Fecal Microbiota Transplant for Anorexia Nervosa
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fecal Microbiota Transplant, Placebo.
- Who it may be relevant to
- Registry conditions: Anorexia Nervosa Restricting Type, Anorexia Nervosa, Anorexia in Adolescence, Anorexia in Children. Basic parameters: 12 years — 17 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Pilot Feasibility Randomized Controlled Trial of Fecal Microbiota Transplant for Adolescent Anorexia Nervosa
Overview
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.
Detailed description
In the following pilot randomized-controlled trial, the investigators' aim is to determine whether FMT treatment demonstrates feasibility, acceptability, and preliminary effectiveness in pediatric AN participants. The investigators will assess how the use of FMT affects participants' rate of weight restoration, gut microbiome, relevant urine and blood biomarkers, and mood symptoms. The investigators' rationale for performing the study is to better understand the interactions between the intestinal microbiome, energy regulation, and behavior. This will be the first study to assess the role of FMT in pediatric AN and will help establish whether this adjunctive treatment modality has benefit in managing the metabolic and behavioral manifestations of this complex neuropsychiatric disorder.
In terms of study procedures, members of a pilot sample of 20 AN patients recruited from McMaster Children's Hospital will be randomized to receive FMT or placebo. All participants will be asked to complete a battery of assessments at regular intervals over the 8-week intervention period, and at a follow-up point at four weeks post-intervention.
The study's primary outcomes are recruitment and retention rates. Descriptive statistics will be used to determine the number of adolescents who will agree to participate in the study and those who will complete the study.
One of the study's secondary outcomes is participants' attitudes toward FMT. This will be measured through qualitative interviews among those who completed the intervention and those who do not agree to participate in the study.
The investigators will know we have reached saturation by using a method called "information power" and will explore how broad the research questions are, if there are clear theories to guide the analysis, how varied the participants in the study are, and how much useful information is accrued. Based on this, the investigators will determine the appropriate number of interviews to lead.
The remaining secondary outcome is a battery of preliminary outcomes (clinical, biological, biochemical and safety). The investigators will assess these outcomes at multiple timepoints using questionnaires, anthropometric data, stool analysis (16s rRNA), urine metabolic analysis, saliva ultra filtrates, changes in blood work, and common terminology criteria for adverse events for safety outcomes.
Interventions
- Biological Fecal Microbiota Transplant
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. - Drug Placebo
Oral placebo capsules (OPC) containing methylcellulose, to be taken twice per day, twice per week over an 8-week duration.
Primary outcome measures
- Recruitment Rate [Time frame: Through study completion, an average of one year.]
- Retention Rate [Time frame: Through study completion, an average of one year.]
Secondary outcome measures (12)
- Attitudes towards Fecal Microbiota Transplant [Time frame: Week 12 (follow-up)]
- Height [Time frame: Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)]
- Weight [Time frame: 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 [Time frame: Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)]
- Beck Depression Inventory [Time frame: Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)]
- Beck Anxiety Inventory [Time frame: Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)]
- Yale-Brown-Cornell Eating Disorder Scale [Time frame: Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)]
- Gastrointestinal Symptom Rating Scale [Time frame: Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)]
- Changes in stool metabolites [Time frame: Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)]
- Changes in urine metabolomics [Time frame: Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)]
- Changes in saliva ultrafiltrates [Time frame: Week 0 (baseline), Week 4 (mid-treatment), Week 8 (post-intervention), Week 12 (follow-up)]
- Changes in complete blood count [Time frame: Week 0 (baseline), Week 8 (post-intervention)]
Eligibility criteria
Inclusion Criteria: All study subjects will have been diagnosed with AN (restricting type or binge eating/purging type) by the primary physician on the ED team, as per standard approach. Study participants will:
- 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
Exclusion Criteria: Potential study subjects will be excluded due to the following reasons:
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Couturier J, Kenner E, Nicula M, Chowdhury F, Surette M, Pai N. Protocol for a pilot feasibility randomised controlled trial of fecal microbiota transplantation for adolescent anorexia nervosa. BMJ Open. 2026 Apr 20;16(4):e109115. doi: 10.1136/bmjopen-2025-109115. PMID 42009386
Identifiers
NCT: NCT06593366 · FMTAN