Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000368538
Ethics application status
Approved
Date submitted
5/01/2024
Date registered
28/03/2024
Date last updated
10/11/2024
Date data sharing statement initially provided
28/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating Sodium Butyrate as Treatment for Anorexia Nervosa
Scientific title
Evaluating the Effectiveness of Sodium Butyrate for Treatment of Anorexia Nervosa in Individuals Aged 16 and Over - An Open-Label Proof of Concept Study
Secondary ID [1] 311266 0
Nil known
Universal Trial Number (UTN)
Trial acronym
S-BAN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anorexia Nervosa 332491 0
Condition category
Condition code
Mental Health 329182 329182 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Drug - Sodium butyrate
Dose - 1 g once daily
Duration - 12 weeks
Mode - Oral tablet

Adherence monitoring:
We'll be asking participants of their adherence during the fortnightly catch-up.
We typically ask:
- Have you missed any pills in the last fortnight? If so, how many
- How many pills do you have left?
- If more than 2 pills missed, did you miss these 2 days in a row?
- Record any other details

The fortnightly catch-up will be conducted by the study doctor or nurse. It will either be a brief 5-10 min phone call or completed in conjunction with a visit to the research site (depending on whether the participant is scheduled to visit the research site that week). Participants will also undertake a nutritional assessment with a dietician at baseline. This assessment should take approximately 30 minutes. Further, those participants who are not already receiving external clinical care will be receiving supportive therapy from trained research staff on a fortnightly basis. This will either be a 30 minute phone or Zoom call or completed in conjunction with a visit to the research site, depending on whether the participant is scheduled to visit the research site that week.

Scheduled visits to the research site will take place at Baseline (3 hours), Week 4 (1 hour), Week 8 (1 hour), Week 12. (2.5 hours) There will also be a scheduled follow-up visit to the research site 3 months after having completed the study., which should take approximately 1 hour.

Baseline Visit:
At the Baseline Visit, the following assessments will be conducted:
• The participant will be asked some questions regarding current symptoms of AN, quality of life and readiness to change.
• The participant will be required to complete some cognitive tasks that measure thinking (i.e., memory and attention), and decision-making skills.
• The participant will be asked to fixate on a fixation cross while being measured using an eye tracker.
• A physical examination will be performed by a nurse or the study doctor.
• A nutritional assessment, where we ask questions about dietary intake
At the end of this session, the study medication will be prescribed.

Visits 3 and 4
The participant will be:
• asked questions about mood and symptoms
• asked about experiences of side effects and any adverse events or health problems since last visit
• A physical examination will be performed by a nurse or the study doctor
• A blood test to measure liver, kidney, white blood cell, inflammation, glucose, hormones and levels of calcium, magnesium and phosphate .(25 ml)

Visit 5: Final Treatment Visit
The following assessments will be conducted:
• The participant will be asked some questions regarding current symptoms of AN, quality of life and readiness to change.
• The participant will be asked whether he/she has experienced any side effects or adverse events.
• The participant will be interviewed regarding mood and other symptoms in the past two weeks.
• The participant will be asked questions about your quality of life.
• The participant will be asked to fixate on a fixation cross while being measured using an eye tracker
• A physical examination will be performed by the study doctor.
• If completed at baseline, the participant will be required to complete some cognitive tasks that measure thinking (i.e., memory and attention) skills and decision-making skills .
• Blood tests and a urine and faecal sample will be collected to assess how symptoms affect biological markers in the blood. These will be compared to the blood tests collected at baseline and throughout the study to assess response to the medication.
• A blood test to measure your liver, kidney, white blood cell, inflammation, glucose, hormones and levels of calcium, magnesium, phosphate and zinc (24.5 ml)
• A saliva test to measure your cortisol levels (1 x 5 ml). This will be compared to the saliva samples collected at baseline to assess response to the medication.
• The participant will be asked to provide a stool sample (can be collected at home or in a private space at the research site, depending on preference) to measure butyrate and zinc levels.
• A nutritional assessment,
• Cortisol measures will be evaluated via saliva samples (1x 5mL) This will be compared to the saliva samples collected at baseline to assess your response to the medication.

The supportive therapy will be administered either by a mental health dietician, psychologist or trained research staff. During supportive therapy sessions, we will check in to see how the participant is doing. The sessions will be non-judgemental and led by the participant, and will allow us to establish a good therapeutic alliance and identify your strengths.
Intervention code [1] 327720 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337026 0
Change in eating disorder symptoms
Timepoint [1] 337026 0
Baseline (pre-commencement), Week 4 (post-intervention commencement), Week 8 (post-intervention commencement), Week 12 (primary endpoint) after intervention commencement, 3-month Follow-Up (post end-of-treatment)
Primary outcome [2] 337027 0
Change in Body Mass Index
Timepoint [2] 337027 0
Baseline (pre-commencement), Week 4 (post-intervention commencement), Week 8 (post-intervention commencement), Week 12 (primary endpoint) after intervention commencement, 3-month Follow-Up (post end-of-treatment)
Secondary outcome [1] 430410 0
Change in eating disorder symptoms
Timepoint [1] 430410 0
Baseline (pre-commencement), Week 4 (post-intervention commencement), Week 8 (post-intervention commencement), Week 12 after intervention commencement
Secondary outcome [2] 430411 0
Change in eating disorder symptoms
Timepoint [2] 430411 0
Baseline (pre-commencement), Week 4 (post-intervention commencement), Week 8 (post-intervention commencement), Week 12 after intervention commencement
Secondary outcome [3] 430412 0
Change in clinical impariment
Timepoint [3] 430412 0
Baseline (pre-commencement), Week 4 (post-intervention commencement), Week 8 (post-intervention commencement), Week 12 after intervention commencement
Secondary outcome [4] 430413 0
Change in body image
Timepoint [4] 430413 0
Baseline (pre-commencement), Week 4 (post-intervention commencement), Week 8 (post-intervention commencement), Week 12 after intervention commencement
Secondary outcome [5] 430414 0
Change in eating attitude
Timepoint [5] 430414 0
Baseline (pre-commencement), Week 4 (post-intervention commencement), Week 8 (post-intervention commencement), Week 12 after intervention commencement
Secondary outcome [6] 430415 0
Change in eating disorder symptoms
Timepoint [6] 430415 0
Baseline (pre-commencement), Week 12 after intervention commencement
Secondary outcome [7] 430416 0
Change in eating disorder symptoms
Timepoint [7] 430416 0
Baseline (pre-commencement), Week 4 (post-intervention commencement), Week 8 (post-intervention commencement), Week 12 after intervention commencement
Secondary outcome [8] 430417 0
Change in eating disorder symptoms
Timepoint [8] 430417 0
Baseline (pre-commencement), Week 4 (post-intervention commencement), Week 8 (post-intervention commencement), Week 12 after intervention commencement
Secondary outcome [9] 430418 0
Change in fear of food
Timepoint [9] 430418 0
Baseline (pre-commencement), Week 4 (post-intervention commencement), Week 8 (post-intervention commencement), Week 12 after intervention commencement
Secondary outcome [10] 430419 0
Change in self-efficacy
Timepoint [10] 430419 0
Baseline (pre-commencement), Week 4 (post-intervention commencement), Week 8 (post-intervention commencement), Week 12 after intervention commencement
Secondary outcome [11] 430420 0
Change in readiness to change
Timepoint [11] 430420 0
Baseline (pre-commencement), Week 4 (post-intervention commencement), Week 8 (post-intervention commencement), Week 12 after intervention commencement

Eligibility
Key inclusion criteria
1. Diagnosis of anorexia nervosa (restrictive or binge-eating/purging subtype), in accordance with the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5).
2. 16 years or older in age.
3. Baseline body mass index (BMI) greater than or equal to 14
4. Demonstrated capacity to give informed consent.
5. No initiation of therapies targeting AN within the 4 weeks prior to screening. This includes pharmacological and psychological therapies.
6. No increase or initiation of medications with appetite suppressing and/or weight loss effects within the 4 weeks prior to screening.
7. Engagement with a GP at the time of enrolment and over the course of trial participation.
8. Consent for the research team to communicate with the participant’s clinical treatment team in regard to a) Their progress through the trial and b) Communicate clinical deterioration and risks to allow facilitation of appropriate management, where clinically-indicated.
9. Eligibility for Medicare

Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Inability to provide informed consent.
2. Hospitalisation within the 2-months prior to screening for the purpose of managing risk of refeeding or treatment of other medical instability that has a causal link with AN.
3. Physical parameters meeting Criteria for Medical Ward Admission as per the RANZCP Alfred Health Eating Disorder – Inpatient Access and Treatment Pathways Guideline, namely:
a. High refeeding risk;
b. Vital signs as follows:
i. Systolic BP less than 80 mmHg;
ii. Postural BP drop greater than 20 mmHg systolic, greater than 10 mmHg diastolic;
iii. Heart rate less than 40 or greater than 110;
iv. Postural tachycardia greater than 20bpm
v. Temperature less than 35.5°C.
c. ECG changes not overtly benign
d. Blood tests within the preceding 7 days showing:
i. Blood Glucose less than 3.0 mmol/L
ii. Serum sodium less than 130 mmol/L
iii. Serum magnesium less than 0.6 mmol/L
iv. Serum potassium less than 3.0 mmol/L
v. Serum phosphate less than 0.7 mmol/L
vi. Glomerular filtration rate less than 60ml/min (Cockroft-Gault)
vii. Albumin less than 27 g/L
viii. Liver Enzymes ALT greater than 3 x upper limit of normal
ix. Neutrophils less than 1.0x109/L
e. GCS less than 15
4. Participants who are pregnant or breastfeeding
5. Taking more than 4 psychotropic medications at the time of screening.
6. Diagnosed with Type I diabetes, hyperthyroidism, Crohn’s disease or other conditions that reduce weight
7. Other clinically significant cardiac, respiratory, renal, oncological or endocrine conditions, or evidence of medical instability, at the clinical judgement of the investigator.
8. Current substance use meeting DSM-5 criteria for severe substance use disorder.
9. Diagnosis of any other mental disorder that is the participant’s primary diagnosis or main mental health syndrome of concern at the time of screening, which may significantly affect psychiatric status and assessed as likely to impact trial participation, at the clinical judgement of the investigator.
10. Use of any investigational procedure (e.g., clinical trial) within 30 days prior to randomisation. In case of exposure to an investigational medicinal product, the investigator must ensure that it is adequately washed out prior to randomisation (at least 30 days or 5 half-lives of the investigational medicinal product, whatever is longer).
11. Participants with severe and enduring anorexia, defined by an illness duration of at least 7 years.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/05/2024
Actual
21/10/2024
Date of last participant enrolment
Anticipated
10/03/2025
Actual
Date of last data collection
Anticipated
10/06/2025
Actual
Sample size
Target
15
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315524 0
University
Name [1] 315524 0
Monash University
Country [1] 315524 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Faculty of Education Monash University19 Ancora Imparo Way, Clayton Victoria 3800 Australia
Country
Australia
Secondary sponsor category [1] 317607 0
None
Name [1] 317607 0
Address [1] 317607 0
Country [1] 317607 0
Other collaborator category [1] 282910 0
Other
Name [1] 282910 0
Victoria Point Pharmacy
Address [1] 282910 0
Pelican’s Nest Shopping Centre Shop 10, 149 Colburn Ave Victoria Point QLD 4165
Country [1] 282910 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314424 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 314424 0
Ethics committee country [1] 314424 0
Australia
Date submitted for ethics approval [1] 314424 0
10/01/2024
Approval date [1] 314424 0
14/06/2024
Ethics approval number [1] 314424 0

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

Contacts
Principal investigator
Name 131530 0
Prof Jayashri Kulkarni
Address 131530 0
Multidisciplinary Alfred Psychiatry Research Centre Level 4 607 St Kilda Road 3004 Melbourne VIC
Country 131530 0
Australia
Phone 131530 0
+61 03 9076 6564
Fax 131530 0
Email 131530 0
jayashri.kulkarni@monash.edu
Contact person for public queries
Name 131531 0
Eva Gregertsen
Address 131531 0
Multidisciplinary Alfred Psychiatry Research Centre Level 4 607 St Kilda Road 3004 Melbourne VIC
Country 131531 0
Australia
Phone 131531 0
+61 3 9076 9802
Fax 131531 0
Email 131531 0
eva.gregertsen@monash.edu
Contact person for scientific queries
Name 131532 0
Eva Gregertsen
Address 131532 0
Multidisciplinary Alfred Psychiatry Research Centre Level 4 607 St Kilda Road 3004 Melbourne VIC
Country 131532 0
Australia
Phone 131532 0
+61 3 9076 9802
Fax 131532 0
Email 131532 0
eva.gregertsen@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.