Fecal Microbiota Transplant for Anorexia Nervosa

NCT06593366 | Not Yet Recruiting DMC

• 1 other identifier: FMTAN
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this pilot randomized-controlled trial is to determine whether Fecal Microbiota Transplant (FMT) treatment demonstrates feasibility, acceptability, and prelinary effectiveness among patients with anorexia nervosa (AN). Specifically, the investigators aim to compare changes in weight, gut microbiome, urine, blood biomarkers and mood symptoms between participants receiving the FMT intervention and placebo.

Conditions

Anorexia Nervosa Restricting Type; Anorexia Nervosa; Anorexia in Adolescence; Anorexia in Children; Anorexia

Keywords

anorexia nervosa; fecal microbiota transplant; pilot study; randomized controlled trial; feasibility

Outcome Measures

Primary Outcomes (2)

• Recruitment Rate

  The number of participants who are consented into the study divided by the number of participants who show interest in the study.

  Through study completion, an average of one year.

• Retention Rate

  The number of participants who completed the study divided by the number of participants consented into the study.

  Through study completion, an average of one year.

Secondary Outcomes (21)

• Attitudes towards Fecal Microbiota Transplant

  Week 12 (follow-up)

• Height

  Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)

• Weight

  Week 0 (baseline), Week 2, Week 4 (mid-treatment), Week 6, Week 8 (post-intervention), Week 10, Week 12 (follow-up)

• Eating Disorder Examination Questionnaire

  Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)

• Beck Depression Inventory

  Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)

Study Arms (2)

Fecal Microbiota Transplant

ACTIVE COMPARATOR

Banked donor stools that have been previously screened, prepared and frozen per previous protocols will be used to prepare all oral FMT capsules (OFC) through the laboratory of a collaborator. Recipients will receive OFC (two capsules, twice a day, twice per week) prepared from a single donor throughout their 8-week treatment course, to support assessment of FMT engraftment in recipients; this totals to 64 capsules across the duration of the study. Each OFC will contain approximately 15.0g of dried healthy donor stool contained within a size 00 gelatin capsule.

Biological: Fecal Microbiota Transplant

Placebo

PLACEBO COMPARATOR

Matching oral placebo capsules (OPC) containing methylcellulose will be identical in terms of size, colour, taste, and dosing. Participants will be asked to take the Placebo treatment capsules twice a day for two days per week for a duration of eight weeks (total 64 capsules).

Drug: Placebo

Interventions

Fecal Microbiota Transplant BIOLOGICAL

An investigational biologic comprised of 15.0g of dried healthy donor stool contained within a size 00 gelatin capsule, to be taken twice per day, twice per week over an 8-week duration.

Fecal Microbiota Transplant

Placebo DRUG

Oral placebo capsules (OPC) containing methylcellulose, to be taken twice per day, twice per week over an 8-week duration.

Placebo

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Be 12-17 years-old at time of recruitment
• Have capacity to consent
• Be assigned female sex at birth (may be gender diverse)
• Be active patients in the pediatric ED program at MCH
• Have a weight that is \<85% of the Treatment Goal Weight, as determined by the treating physician

You may not qualify if:

• Exposure to antibiotics within two weeks of study randomization
• Initiation of new probiotics / oral nutritional supplements within two weeks of randomization
• Active pregnancy
• Active psychosis or suicidal ideation
• Other comorbidities that may affect weight or the gut microbiome including celiac disease, inflammatory bowel disease (or other conditions as determined by the study team)

Sponsors & Collaborators

• McMaster University: lead

MeSH Terms

Conditions

Anorexia Nervosa; Anorexia

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Jennifer L Couturier, MD, MSc

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer L Couturier, MD, MSc

CONTACT

905-521-2100; coutur@mcmaster.ca

Nikhil Pai, MD

CONTACT

905-521-2100; pain@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All parties will be blinded to the participant's treatment arm.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: September 19, 2024
• Study Start: January 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 22, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share