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Trial registered on ANZCTR
Registration number
ACTRN12626000765325p
Ethics application status
Submitted, not yet approved
Date submitted
9/06/2026
Date registered
26/06/2026
Date last updated
3/09/2026
Date data sharing statement initially provided
26/06/2026
Type of registration
Prospectively registered
Titles & IDs
Public title
A pilot study of the feasibility and safety of faecal microbiota transplantation in adults with alcohol use disorder and alcohol-related liver disease
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Scientific title
A pilot study of the feasibility and safety of faecal microbiota transplantation in adults with alcohol use disorder and alcohol-related liver disease
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Additional trial identifiers [1]
317520
0
GALA-FMT-V1
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Universal Trial Number (UTN)
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Trial acronym
GALA-2 FMT
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Related trial records
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Health condition
Health condition(s) studied:
Alcohol use disorder
342265
0
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Alcohol-related liver disease
342266
0
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Condition category
Condition code
Mental Health
338379
338379
0
0
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Addiction
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Oral and Gastrointestinal
338380
338380
0
0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of the intervention or exposure
Participants randomised to the intervention arm will receive faecal microbiota transplantation (FMT), administered as a single rectal enema at Week 0.
Intervention name and product
Faecal microbiota transplantation using BIOMICTRA (BiomeBank), an FMT product included in the Australian Register of Therapeutic Goods (ARTG 399066). The product is supplied as two 50 mL frozen syringes, providing a total administered volume of 100 mL containing 25 g of donor stool.
BIOMICTRA is included in the ARTG for restoration of the gut microbiota in the treatment of recurrent Clostridioides difficile infection. Its use in this trial for alcohol use disorder and alcohol-associated liver disease is outside the approved indication and will occur under the Clinical Trial Notification scheme.
Dose and treatment duration
Each participant allocated to the intervention arm will receive one FMT treatment comprising two 50 mL syringes administered sequentially as a single 100 mL rectal enema containing 25 g of donor stool.
Minimum dose to be tested: one administration of 100 mL containing 25 g of donor stool.
Maximum dose to be tested: one administration of 100 mL containing 25 g of donor stool.
The intervention will be administered once only. No repeat dosing will occur during the 12-week primary follow-up or the extended follow-up to Month 6.
Timing and setting
The FMT enema will be administered at Week 0, on day 5 ± 2 of the participant’s supervised inpatient alcohol-withdrawal admission at the De Paul House residential Alcohol and Other Drug Withdrawal Unit, St Vincent’s Hospital Melbourne. The inpatient admission is expected to last 7 ± 2 days.
Mode of delivery and administration procedure
FMT will be administered face-to-face to an individual participant by the rectal route. The participant will be positioned in the left lateral decubitus position. A sterile, soft silicone Foley catheter of 14–16 Fr will be lubricated and inserted approximately 3–5 cm into the rectum without inflation of the distal balloon. The contents of the two 50 mL syringes will be instilled sequentially while the catheter remains in position.
Following administration, the catheter will be removed and the participant will be repositioned prone with a pillow beneath the hips. The participant will be asked to retain the instillate for at least 30 minutes, and the actual retention time will be recorded.
No bowel preparation, laxative, antibiotic preconditioning, sedation or endoscopy will be used as part of the intervention.
Intervention provider and training
The intervention will be administered by a study nurse or medically qualified investigator who has completed protocol-specific training and documented competency assessment. Authorisation to administer the intervention will be recorded in the trial delegation log.
Relevant study personnel will hold current Good Clinical Practice certification and will be trained in product handling, chain of custody, participant identification, confirmation of eligibility and allocation, rectal-enema administration, recognition and reporting of adverse events, protocol-deviation documentation and completion of study source documents. Competency will be documented before the staff member performs the procedure.
Adherence and intervention fidelity
As this is a single, directly administered intervention, adherence will be assessed by documenting whether the allocated FMT treatment was administered and whether administration was complete.
A participant-specific administration checklist will record:
- confirmation of participant identity, eligibility and treatment allocation;
- product identity, batch or lot number and expiry date;
- volume delivered and completeness of administration;
- date and time of administration;
- retention time;
- immediate tolerability events;
- post-procedure observations; and
- any procedural or protocol deviations.
Intervention fidelity will be supported through the study administration procedure, protocol-specific training, documented competency, the delegation log, the participant-specific administration checklist, source-data verification and trial monitoring.
Post-administration monitoring
Participants will be observed for at least two hours following FMT administration. Vital signs will be recorded at baseline and approximately 30, 60 and 120 minutes after administration. Immediate adverse events will be documented, and participants will receive written post-procedure safety information and emergency contact details. A safety telephone call will be conducted approximately 48–72 hours after the procedure.
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Intervention code [1]
334318
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Treatment: Drugs
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Intervention code [2]
334440
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Treatment: Other
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Description of the comparator or control
Participants randomised to the comparator arm will receive standard of care.
Participants in this arm will undergo the same supervised inpatient alcohol-withdrawal admission at the De Paul House residential Alcohol and Other Drug Withdrawal Unit, St Vincent’s Hospital Melbourne, as participants allocated to FMT. The admission is expected to last 7 ± 2 days. Participants will receive evidence-based addiction and hepatology care, including medically supervised alcohol withdrawal, addiction support and, where clinically indicated, relapse-prevention pharmacotherapy and hepatology management.
Participants in the standard-of-care arm will not receive an enema, placebo, sham treatment, carrier-only preparation or other study-specific rectal procedure. No rectal instrumentation will be performed. Therefore, the dose, route of administration, treatment duration, intervention-provider training and comparator-adherence procedures are not applicable to this arm.
For participants in the standard-of-care arm, Week 0 will be the equivalent day of the inpatient admission—day 5 ± 2—on which participants in the intervention arm receive FMT. Both arms will otherwise follow the same schedule of study visits, clinical assessments, validated questionnaires, safety assessments and biospecimen collection through Week 12, with extended follow-up to Month 6.
Usual clinical care will not be restricted. Any clinically indicated treatment will take priority over study procedures and will be documented as concomitant therapy. Completion of the assessment, questionnaire and biospecimen schedule, together with retention to Week 12, will be monitored as part of the study’s feasibility outcomes.
The standard-of-care arm will provide contemporaneous information regarding feasibility, retention, alcohol-use outcomes and background clinical and safety-event rates in the study population. Between-arm comparisons will estimate the combined effect of the FMT product and its administration procedure relative to standard care without a rectal procedure.
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Control group
Active
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Outcomes
Primary outcome [1]
345692
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Feasibility of conducting a randomised, open-label, standard-of-care-controlled pilot trial of faecal microbiota transplantation in adults with alcohol use disorder and alcohol-associated liver disease. Feasibility will be assessed using prespecified recruitment, eligibility, consent, intervention-completion, retention, biospecimen-completeness and questionnaire-completeness rates. Intervention completion is defined as receipt of the full allocated FMT enema among participants randomised to FMT; participants allocated to standard care receive no study intervention or placebo procedure.
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Assessment method [1]
345692
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Feasibility will be assessed using screening, recruitment and consent logs; REDCap electronic case report forms; FMT administration checklists; study-visit records; questionnaire-completion records; and biospecimen-collection records. Recruitment rate will be calculated as the number of participants enrolled per month during the recruitment period. Eligibility rate will be calculated as the number of eligible participants divided by the number screened. Consent rate will be calculated as the number who provide consent divided by the number of eligible participants approached. Intervention-completion rate will be calculated only for the FMT arm and defined as the number of participants who receive the full allocated FMT enema divided by the number randomised to FMT. Participants allocated to standard care will not receive an enema, placebo or other study-specific intervention. Retention rate will be calculated as the number of participants completing the Week 12 visit divided by the total number randomised. Biospecimen completeness will be calculated as the number of scheduled stool, blood and saliva samples collected and evaluable divided by the number expected through Week 12. Questionnaire completeness will be calculated as the number of scheduled questionnaires completed divided by the number expected through Week 12.
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Timepoint [1]
345692
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Recruitment rate assessed throughout the recruitment period. Eligibility and consent assessed at screening. Intervention completion assessed at Week 0. Biospecimen and questionnaire completeness assessed from Week 0 to Week 12. Retention assessed at Week 12 after randomisation, which is the primary feasibility endpoint.
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Primary outcome [2]
345693
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Safety of a single rectal FMT enema compared with standard care, assessed by: 1. the proportion of participants randomised to FMT who experience at least one FMT-related or administration-procedure-related adverse event through Week 12; 2. all-cause and treatment-related serious adverse events, reported separately by treatment arm through Week 12, with serious adverse event ascertainment continuing to Month 6; and 3. adverse events of special interest associated with FMT, including infection or transmission events, sepsis or bacteraemia, gastrointestinal complications, hepatic decompensation, hospitalisation and death. The standard-of-care arm will provide contemporaneous background clinical and safety-event rates in the same population and setting.
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Assessment method [2]
345693
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Safety will be assessed by active adverse event surveillance at study visits and safety calls, participant report, clinical assessment, vital signs, infection surveillance, hospital record review and investigator assessment of severity, causality and expectedness. Adverse events of special interest include infection or suspected pathogen transmission, sepsis or bacteraemia, significant gastrointestinal symptoms or complications, hepatic decompensation, hospitalisation, death, pregnancy during the study, product recall or post-release donor-screening failure affecting an administered product. Vital signs measured at each in-person visit and during post-procedure observation are: systolic and diastolic blood pressure (automated oscillometric sphygmomanometer, with a manual aneroid sphygmomanometer and stethoscope as backup); heart rate and peripheral oxygen saturation (SpO2) (multiparameter patient monitor with pulse oximetry); respiratory rate (manual count over 60 seconds); and body temperature (digital tympanic thermometer). Adverse-event surveillance, infection surveillance, clinical assessment, hospital-record review, and investigator assessment of severity, causality and expectedness are as previously described.
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Timepoint [2]
345693
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Adverse events and adverse events of special interest assessed from Week 0 to Week 12, including 48–72 hours after intervention, Week 1, Week 2, Week 4, Week 8 and Week 12. Serious adverse events assessed from consent to Month 6 after randomisation.
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Primary outcome [3]
345804
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Tolerability and acceptability of a single rectal FMT enema versus standard of care, This will be assessed as a composite outcome
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Assessment method [3]
345804
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Assessed using a study staff procedural checklist and participant-reported acceptability questionnaire. Tolerability will be assessed peri-procedurally by study staff from the start of enema instillation to completion of the on-site observation period. A participant will be classified as tolerating the procedure if the allocated enema is administered as planned, the procedure is completed, the enema is retained for the protocol-defined minimum retention period of 30 minutes, and there is no premature discontinuation due to discomfort, distress, abdominal cramping, rectal discomfort, urgency, embarrassment, withdrawal of consent, or other intolerance. Acceptability will be assessed using a participant questionnaire rating overall acceptability, procedural burden, discomfort, embarrassment/privacy concerns, and willingness to undergo the same intervention again. The composite outcome will be met only if both tolerability and acceptability criteria are satisfied. A participant meets the outcome if they receive the full allocated enema volume and complete administration without a pre-specified intolerance event. Pre-specified intolerance events are: (i) failure to retain the full instilled volume for at least 30 minutes; (ii) involuntary evacuation or leakage of the instillate before 30 minutes; (iii) participant request to cease the procedure; or (iv) abdominal pain, cramping or urgency of at least moderate severity (=4 on a 0–10 numeric rating scale) that the participant characterises as intolerable. Administration completeness is recorded by the administering clinician at the conclusion of instillation. Retention failure and intolerance events are ascertained continuously by direct clinical observation across the instillation and retention window and during a subsequent on-site observation period, with the participant's self-report as the trigger for symptom- and request-based events and the administering clinician as adjudicator. The analysis population is a modified intention-to-treat population comprising all randomised participants who attend and commence enema administration; receipt of the full enema forms part of the outcome and does not condition the denominator. Randomised participants who do not attend, or who attend but in whom administration is not commenced for a non-tolerability reason (e.g. clinician decision, equipment failure), are reported with reasons and excluded from the tolerability denominator. Each participant contributes a single determination; there are no repeated measures. Where participant blinding to allocation is maintained, assessment is masked to allocation to limit differential intolerance reporting between arms. The proportion meeting the outcome will be reported by arm with an exact (Clopper–Pearson) 95% confidence interval.
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Timepoint [3]
345804
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Day 7 post-intervention. The composite outcome will incorporate peri-procedural tolerability data collected on Day 0 from the start of enema instillation to completion of the 30-minute minimum retention period and 30-minute on-site observation period, plus participant-reported acceptability assessed at Day 7.
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Secondary outcome [1]
462927
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Change in alcohol consumption, assessed as percentage heavy-drinking days and standard drinks per drinking day.
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Assessment method [1]
462927
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Alcohol consumption will be assessed using the Timeline Follow-Back method.
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Timepoint [1]
462927
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Screening, Week 0, Week 2, Week 4, Week 8, Week 12 and Month 6 after randomisation.
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Secondary outcome [2]
462928
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Change in phosphatidylethanol concentration as an objective biomarker of alcohol exposure.
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Assessment method [2]
462928
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Whole-blood phosphatidylethanol testing by laboratory assay.
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Timepoint [2]
462928
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Screening, Week 0, Week 2, Week 4, Week 8, Week 12 and Month 6 after randomisation.
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Secondary outcome [3]
462931
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Change in liver biochemistry.
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Assessment method [3]
462931
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Laboratory testing including gamma-glutamyl transferase, aspartate aminotransferase, alanine aminotransferase, bilirubin, albumin, international normalised ratio and platelet count.
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Timepoint [3]
462931
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Screening, Week 0, Week 2, Week 4, Week 8, Week 12 and Month 6 after randomisation.
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Secondary outcome [4]
462932
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Change in alcohol craving.
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Assessment method [4]
462932
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Penn Alcohol Craving Scale.
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Timepoint [4]
462932
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Week 0, Week 2, Week 4, Week 8, Week 12 and Month 6 after randomisation.
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Secondary outcome [5]
462933
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Change in non-invasive measures of liver disease severity.
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Assessment method [5]
462933
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Model for End-Stage Liver Disease score, Child-Pugh class where applicable, Fibrosis-4 Index, AST to Platelet Ratio Index, transient elastography and hand-grip strength.
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Timepoint [5]
462933
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Screening, Week 0, Week 4, Week 12 and Month 6 after randomisation, with transient elastography assessed at screening and Week 12.
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Secondary outcome [6]
462934
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Change in health-related quality of life.
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Assessment method [6]
462934
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EQ-5D-3L questionnaire.
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Timepoint [6]
462934
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Week 0, Week 4, Week 12 and Month 6 after randomisation.
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Secondary outcome [7]
462938
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Change in psychological symptoms.
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Assessment method [7]
462938
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Depression Anxiety Stress Scales-21.
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Timepoint [7]
462938
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Week 0, Week 4, Week 12 and Month 6 after randomisation.
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Secondary outcome [8]
462939
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Major adverse liver outcomes, hospitalisation and mortality (this will be assessed as a composite secondary outcome). Component events: new or worsening ascites, variceal bleeding, hepatic encephalopathy, liver-related hospitalisation, liver transplantation, and death.
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Assessment method [8]
462939
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Clinical assessment, participant report and medical-record review. Each component event is recorded against pre-specified definitions and reported as the composite and, descriptively, as individual components. All-cause hospitalisation and all-cause mortality are captured within the composite.
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Timepoint [8]
462939
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Assessed from randomisation to Week 12 and Month 6 after randomisation.
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Secondary outcome [9]
462940
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Change in gut microbiome diversity, composition and functional potential (this will be assessed as a composite secondary outcome).
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Assessment method [9]
462940
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Shotgun metagenomic sequencing of stool samples, including alpha diversity, beta diversity, taxonomic composition and functional pathway profiling; in the FMT arm, donor–recipient engraftment and strain transfer are additionally quantified.
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Timepoint [9]
462940
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Week 0, Week 2, Week 4, Week 12 and Month 6 after randomisation.
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Eligibility
Key inclusion criteria
Adults aged 18 years or older with moderate-to-severe alcohol use disorder, defined by Alcohol Use Disorders Identification Test (AUDIT) score of 15 or greater, and compensated alcohol-associated liver disease. Alcohol-associated liver disease may be evidenced by deranged liver biochemistry, including AST greater than 50 IU/L and AST:ALT ratio greater than 1.5, and/or liver imaging, elastography or histology consistent with alcohol-associated steatosis, fibrosis or compensated cirrhosis.
Participants must have capacity to provide written informed consent and must not be acutely intoxicated, delirious or in withdrawal severe enough to impair decision-making at the time of consent. Participants must be willing and able to comply with the intervention, study visits, questionnaires and biospecimen collection through the Week 12 primary follow-up visit, with safety follow-up to Month 6. Participants of childbearing potential must have a negative pregnancy test at screening and agree to use effective contraception for the duration of study participation.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Healthy volunteers
No
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Key exclusion criteria
Key exclusion criteria are decompensated cirrhosis, including clinically significant ascites, variceal bleeding, hepatic encephalopathy, jaundice attributable to decompensation, hepatorenal syndrome or multiple organ failure; severe alcohol-associated hepatitis or any other condition requiring urgent inpatient treatment; clinical instability precluding trial participation; primary liver disease of non-alcohol aetiology unless alcohol-associated liver disease criteria are also met; active uncontrolled infection, active gastrointestinal infection, untreated HIV, hepatitis B or hepatitis C, or other transmissible infection judged to increase faecal microbiota transplantation risk; significant immunosuppression, including systemic corticosteroids greater than 10 mg/day prednisolone-equivalent for more than 2 weeks or other clinically relevant immunosuppressive therapy; systemic antibiotics within 4 weeks or probiotics within 2 weeks before baseline; recent initiation or change of proton-pump inhibitor therapy within 2 months; significant change in anti-craving pharmacotherapy within 2 weeks before baseline unless otherwise permitted by the final protocol; active inflammatory bowel disease; recent major gastrointestinal or endoscopic surgery within 3 months; major gastrointestinal surgery altering gastrointestinal continuity; anatomical or clinical contraindication to rectal enema; active malignancy or malignancy within 5 years other than non-melanoma skin cancer; solid-organ transplantation; pregnancy or breastfeeding; known severe food allergy, anaphylaxis, or other contraindication specified in the final FMT product documentation; inability to provide informed consent or inability to comply with study requirements.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible, consented participants will be randomised in a 2:1 ratio to faecal microbiota transplantation or standard care. The randomisation sequence will be computer-generated by an independent statistician using randomly permuted blocks of variable size and stratified by the presence or absence of cirrhosis.
The sequence will be implemented through a concealed central REDCap randomisation module. Allocation will remain concealed from investigators involved in eligibility assessment, recruitment and consent until randomisation. Randomisation will occur only after eligibility has been confirmed, informed consent obtained, and baseline pre-intervention questionnaires and biospecimens collected.
Following randomisation, allocation will be disclosed to the participant and treating study team because the treatment phase is open-label. The trial statistician, laboratory and bioinformatic analysts, and independent safety adjudicator will remain blinded in accordance with the protocol. No emergency unblinding procedure is required because treatment allocation is known to participants and the treating team.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be computer-generated by an independent statistician using randomly permuted blocks of variable size. Participants will be allocated in a 2:1 ratio to faecal microbiota transplantation or standard care. Randomisation will be stratified by the presence or absence of cirrhosis, determined using prespecified clinical, radiological, elastographic or histological criteria before randomisation.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1 / Phase 2
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Type of endpoint/s
Safety
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Statistical methods / analysis
The planned sample size is 30 participants, with 20 allocated to faecal microbiota transplantation (FMT) and 10 allocated to standard care in a 2:1 ratio. This is a pilot feasibility and precision target rather than a formal efficacy power calculation. The 2:1 allocation favours FMT because the primary objectives concern the feasibility, acceptability, tolerability and safety of administering FMT, and most information relevant to these objectives is obtained from participants receiving the intervention. The standard-of-care arm will provide contemporaneous information regarding feasibility and background clinical and safety-event rates.
Analyses will be primarily descriptive and consistent with the pilot feasibility design. Feasibility and safety outcomes will be summarised using counts, proportions and 95% confidence intervals, where appropriate. Continuous outcomes will be summarised using means and standard deviations or medians and interquartile ranges, according to their distributions.
The intention-to-treat population will include all randomised participants, analysed according to their allocated arm, and will be the primary population for feasibility and signal-seeking clinical outcomes. The safety population will include all randomised participants, analysed according to the treatment received. FMT-related harms will be attributed to participants who receive FMT, while standard-of-care participants will contribute contemporaneous background event rates. A supportive per-protocol population will include participants completing the allocated intervention, where applicable, and Week 12 follow-up without a major protocol deviation.
Each feasibility measure will be reported as a proportion with an exact 95% confidence interval, or as a rate per month for recruitment, overall and by treatment arm where relevant. Results will be compared with the prespecified traffic-light progression criteria. Reasons for ineligibility, non-consent, intervention non-completion and loss to follow-up will be tabulated.
Adverse events will be summarised by treatment arm using participant-level and event-level counts. Events will be categorised according to seriousness, severity, causality, expectedness and adverse-event category. No formal between-arm hypothesis testing of harms is planned; differences will be described using effect estimates and confidence intervals.
Signal-seeking clinical outcomes, including alcohol consumption, craving and liver-related measures, will be summarised descriptively. Where repeated measurements and data completeness permit, exploratory longitudinal mixed-effects models will include a participant-level random intercept and fixed effects for treatment arm, time and the treatment-by-time interaction, with adjustment for baseline values where appropriate. Binary outcomes will be summarised using counts, proportions and confidence intervals. Time-to-event outcomes will be described using Kaplan–Meier methods only where event numbers are sufficient.
Because the trial is open-label, participant-reported outcomes will be interpreted alongside objective measures, including phosphatidylethanol. Prespecified sensitivity analyses may adjust for baseline treatment expectancy. Any discordance between self-reported alcohol consumption and phosphatidylethanol will be reported.
Microbiome and multi-omics analyses will be exploratory. Alpha diversity will be assessed using measures including Shannon diversity and observed richness. Beta diversity will be assessed using Bray–Curtis dissimilarity and UniFrac distances where phylogenetic data are available. Community composition will be evaluated using PERMANOVA, and differential abundance analyses will use compositionally appropriate methods such as ANCOM-BC with false-discovery-rate control. Donor-strain engraftment will be assessed using strain-level metagenomic tracking where sequencing depth and reference data permit.
No formal confirmatory hypothesis testing is planned for efficacy outcomes. Comparative analyses will be interpreted as hypothesis-generating and will emphasise effect estimates, confidence intervals and biological plausibility. Analyses will be conducted using Stata version 17 and appropriate microbiome and bioinformatics software.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/01/2027
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Actual
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Date of last participant enrolment
Anticipated
30/06/2028
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Actual
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Date of last data collection
Anticipated
31/12/2028
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
29633
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St Vincent's Hospital (Melbourne) Ltd - Fitzroy
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Recruitment postcode(s) [1]
45974
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3065 - Fitzroy
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Funding & Sponsors
Funding source category [1]
322082
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Hospital
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Name [1]
322082
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St. Vincent's Hospital Melbourne - Department of Gastroenterology
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Address [1]
322082
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Country [1]
322082
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Australia
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Funding source category [2]
322088
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Hospital
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Name [2]
322088
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St. Vincent's Hospital Melbourne - Department of Addiction Medicine
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Address [2]
322088
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Country [2]
322088
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Australia
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Primary sponsor type
Hospital
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Name
St. Vincent's Hospital Melbourne
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Address
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Country
Australia
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Secondary sponsor category [1]
324973
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None
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Name [1]
324973
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Address [1]
324973
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Country [1]
324973
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Other collaborator category [1]
283977
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University
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Name [1]
283977
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The University of Melbourne
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Address [1]
283977
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Country [1]
283977
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Australia
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Other collaborator category [2]
283978
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Other Collaborative groups
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Name [2]
283978
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St. Vincent's Institute (SVI)
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Address [2]
283978
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Country [2]
283978
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Australia
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
320616
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St Vincent's Hospital Melbourne Human Research Ethics Committee
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Ethics committee address [1]
320616
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https://svhm.org.au/home/research/researchers/human-research-ethics-committee
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Ethics committee country [1]
320616
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Australia
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Date submitted for ethics approval [1]
320616
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20/07/2026
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Approval date [1]
320616
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Ethics approval number [1]
320616
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Summary
Brief summary
This pilot study will assess whether a single faecal microbiota transplantation (FMT) enema can be delivered safely, acceptably and feasibly to adults with moderate-to-severe alcohol use disorder and compensated alcohol-associated liver disease. Thirty participants will be randomly allocated in a 2:1 ratio to receive either a single rectal FMT enema in addition to standard care or standard care alone. All participants will undergo the same supervised inpatient alcohol-withdrawal admission and receive evidence-based addiction and hepatology care. Participants allocated to standard care will not receive an enema, placebo, sham procedure or rectal instrumentation. Participants will be followed for 12 weeks for the primary feasibility and safety outcomes, with serious adverse event ascertainment and extended clinical follow-up continuing to Month 6. Feasibility outcomes include recruitment, eligibility, consent, FMT-completion, retention, and questionnaire and biospecimen completeness. Safety and tolerability will be assessed using adverse events, serious adverse events and adverse events of special interest associated with FMT. The study will also explore changes in alcohol consumption, alcohol craving, liver-related clinical measures, quality of life, psychological symptoms, gut and oral microbiome features, microbial metabolites and immune or gut-barrier markers. These exploratory analyses are intended to identify preliminary signals and inform the design of future research; the study is not powered to establish whether FMT is clinically effective. The results will determine whether progression to a larger definitive trial of microbiome-targeted therapy for alcohol use disorder and alcohol-associated liver disease is feasible and justified.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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A/Prof Jacinta Holmes
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Address
151054
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St Vincent's Hospital Melbourne, 41 Victoria Parade, Fitzroy VIC 3065, Australia
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Country
151054
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Australia
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Phone
151054
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+61 3 9231 3581
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Fax
151054
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Email
151054
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[email protected]
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Contact person for public queries
Name
151055
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Timothy Phan
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Address
151055
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St Vincent's Hospital Melbourne, 41 Victoria Parade, Fitzroy VIC 3065, Australia
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Country
151055
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Australia
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Phone
151055
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+61 3 9231 2211
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Fax
151055
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Email
151055
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[email protected]
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Contact person for scientific queries
Name
151056
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Timothy Phan
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Address
151056
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St Vincent's Hospital Melbourne, 41 Victoria Parade, Fitzroy VIC 3065, Australia
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Country
151056
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Australia
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Phone
151056
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+61 3 9231 2211
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Email
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment:
Individual participant data will not be made publicly available at this stage. This is a small pilot feasibility and safety trial involving sensitive alcohol use, liver disease, microbiome, biomarker and clinical data. The risk of re-identification may be increased because of the small sample size and specialised participant population. Any future sharing of de-identified data would require approval by the sponsor, the investigator team and the relevant ethics/governance bodies, and would need to be consistent with participant consent.
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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