Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000366459
Ethics application status
Approved
Date submitted
9/04/2025
Date registered
24/04/2025
Date last updated
28/05/2025
Date data sharing statement initially provided
24/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of Gut therapy on Long COVID-19 Outcomes and Wellbeing (The GLOW Trial)
Scientific title
A randomised, double-blind, placebo-controlled feasibility trial of enema-delivered faecal microbiome transplant for Long COVID.
Secondary ID [1] 314172 0
Nil known
Universal Trial Number (UTN)
Trial acronym
GLOW Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Long COVID-19 337023 0
Condition category
Condition code
Infection 333474 333474 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Human faecal microbiome transplantation enemas, comprising donor faeces (16.7g), saline, and glycerol, rectally delivered via 3 x 60mL enemas.
Enemas will be administered one per day on consecutive days. Research nurses will administer the enemas in a clinical setting.
Intervention code [1] 330772 0
Treatment: Other
Comparator / control treatment
Placebo enemas, comprising saline, glycerol, and brown food dye, rectally delivered via 3 x 60mL enemas.
Enemas will be administered one per day on consecutive days. Research nurses will administer the enemas in a clinical setting.
Control group
Placebo

Outcomes
Primary outcome [1] 341051 0
Feasibility
Timepoint [1] 341051 0
Cumulative data will be assessed at the conclusion of the study
Secondary outcome [1] 446373 0
Overall Health Perception
Timepoint [1] 446373 0
Baseline, Week 4 post-first enema and Week 8 post-first enema
Secondary outcome [2] 446372 0
Functional Capacity,
Timepoint [2] 446372 0
Baseline, Week 4 post-first enema and Week 8 post-first enema
Secondary outcome [3] 445956 0
Symptom severity
Timepoint [3] 445956 0
Baseline, Week 4 post-first enema and Week 8 post-first enema

Eligibility
Key inclusion criteria
• Aged 18-65 years.
• Documented diagnosis of Long COVID confirmed by a specialist at a dedicated Long COVID clinic or a healthcare provider with recognised expertise in managing post-COVID conditions, with verifiable documentation.
• Experiencing moderate to severe functional impairment due to their Long COVID, measured as a World Health Organisation Disability Assessment Scale (WHODAS 2.0 12-item) score of greater than 25.
• Willing and able to wear a Garmin wrist health tracking device for the duration of the study, without known allergies to materials used in the device (e.g., nickel, silicone).
• Willing and able to give informed consent prior to study enrolment and to comply with study procedures, including attending the study site for in-person study appointments.
• Able to commit to the ongoing use of hormonal (e.g., oral contraceptive pill, intrauterine device) or non-hormonal (e.g., barrier methods) contraception if sexually active and of childbearing potential age during the trial period.
• Has access to a device capable of downloading and using the WeGuide application, with stable internet access using a smartphone, laptop, or desktop computer.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• History of major gastrointestinal conditions, including but not limited to:
o suspected bowel perforation.
o Coeliac’s disease (due to potential risk of gluten contamination in the FMT).
o severe, active inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis) including recent flares and/or complications (e.g., abscess, fistulae, severe bleeding).
o any other major gastrointestinal conditions considered to increase the risk of complications, compromise participant safety, or confound study outcomes, as determined by the Investigator or their delegate.
• History of major gastrointestinal surgery, including but not limited to:
o resection of large portions of the intestines (e.g., total colectomy, hemicolectomy)
o presence of colostomy or ileostomy
o any other major gastrointestinal surgeries considered to increase the risk of complications, compromise participant safety, or confound study outcomes, as determined by the Investigator or their delegate.
• Known immunosuppression or immunodeficiency, including, but not limited to:
o uncontrolled HIV (e.g., CD4 count < 240 cells/mm3).
o history of bone marrow transplant.
o severe hepatic impairment (e.g., decompensated cirrhosis).
o use of major immunosuppressive agents, including high-dose corticosteroids (e.g., prednisolone greater than 60mg/day, calcineurin inhibitors, mTOR inhibitors, lymphocyte-depleting biologic agents, anti-TNF therapy, or chemotherapy.
o any other immunosuppression or immunodeficiencies considered to increase the risk of complications, compromise participant safety, or confound study outcomes, as determined by the Investigator or their delegate.
• Conditions that prevent safe or comfortable administration of an enema including, but not limited to:
o severe haemorrhoids prone to bleeding or causing significant pain during rectal procedures.
o history of rectal fissures or chronic anal ulcers that could be aggravated by enema insertion.
o rectal prolapse or anal stenosis that may obstruct safe insertion of the enema syringe.
o recent rectal or anal surgery within the past 6 months, such as for fistula repair or haemorrhoidectomy.
o diagnosed conditions that cause involuntary muscle spasms or severe pain in the rectal area (e.g., anismus, proctalgia fugax).
o active perianal infections such as abscesses or other rectal infections.
o history of severe bowel obstruction or chronic constipation that may interfere with enema administration.
o congenital abnormalities of the rectum or anus that obstruct enema insertion.
o significant psychological distress or trauma associated with rectal procedures, making the enema procedure intolerable.
o any other condition considered a contraindication to enema delivery, as determined by the Investigator or their delegate.
• Received FMT (e.g., oral, endoscope, rectal) within the past 12 months prior to consent.
• Use of bowel preparation or administration of any other rectally delivered enema within the past six months prior to consent.
• History of anaphylactic or anaphylactoid reactions, particularly to components that may be present in the FMT preparation.
• Currently pregnant or breastfeeding, or planning pregnancy, egg donation, or egg retrieval within the 8-week study period.
• Males planning to conceive a child or donate sperm during the study or within 90 days after last dose of Investigational Product.
• Participating in another intervention trial that may interfere with study outcomes.
• Known or suspected active and unstable medical disorder that may compromise participant safety, as determined by the Investigator or their delegate.
• Commencement, dosage change, or discontinuation of medication for a stable ongoing condition (e.g., antidepressants) within the 30 days prior to consent (delayed commencement allowed).
• Use of antibiotics within the 30 days prior to consent (delayed commencement allowed).
• Commencement or discontinuation of probiotics, synbiotics, prebiotics, or other supplements intended to impact gut health or the gut microbiome within the 30 days prior to consent (delayed commencement allowed).
• Commencement, dosage change, or discontinuation of COVID-19 specific treatment drugs (e.g., antiviral medications such as Paxlovid, monoclonal antibodies like sotrovimab) within the 30 days prior to consent (delayed commencement allowed).
• Receipt of a COVID-19 vaccine within the 28 days prior to consent or any other vaccination (e.g., influenza, pneumococcal) within the 14 days prior to consent.
• Participants who are mentally or legally incapacitated and unable to provide informed consent, or whose condition may interfere with compliance to the trial protocol, as judged by the Investigator or their delegate.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Concealment will be maintained with an allocation list. The allocation list will link both STUDYIDs with the enema KITID.

Only the unblinded staff member will have access to the list which links the KITID's to either Intervention or Placebo allocations.
This will be stored electronically in a password protected database.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be conducted using permuted block randomisation, with an independent statistician generating and maintaining the allocation list. Upon completion of screening, 40 eligible participants will be randomly allocated in a 1:1 ratio to receive either active FMT enemas (treatment group) or saline enemas (placebo group).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/06/2025
Actual
Date of last participant enrolment
Anticipated
1/12/2025
Actual
Date of last data collection
Anticipated
1/04/2026
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 43924 0
3220 - Geelong

Funding & Sponsors
Funding source category [1] 318688 0
Government body
Name [1] 318688 0
Australian Department of Health and Aged Care, Medical Research Future Fund
Country [1] 318688 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Country
Australia
Secondary sponsor category [1] 321115 0
None
Name [1] 321115 0
Address [1] 321115 0
Country [1] 321115 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317298 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 317298 0
Ethics committee country [1] 317298 0
Australia
Date submitted for ethics approval [1] 317298 0
04/02/2025
Approval date [1] 317298 0
11/03/2025
Ethics approval number [1] 317298 0
RES-25-0000-040A

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 140610 0
Dr Amelia McGuinness
Address 140610 0
Deakin University, 1 Gheringhap Street, Geelong Victoria 3220
Country 140610 0
Australia
Phone 140610 0
+61 3 5227 2217
Fax 140610 0
Email 140610 0
[email protected]
Contact person for public queries
Name 140611 0
Felicity Pendergast
Address 140611 0
Deakin University, 1 Gheringhap Street, Geelong Victoria 3220
Country 140611 0
Australia
Phone 140611 0
+61 3 5227 8576
Fax 140611 0
Email 140611 0
[email protected]
Contact person for scientific queries
Name 140612 0
Felicity Pendergast
Address 140612 0
Deakin University, 1 Gheringhap Street, Geelong Victoria 3220
Country 140612 0
Australia
Phone 140612 0
+61 3 5227 2217
Fax 140612 0
Email 140612 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.