Fecal microbiome transplant for restricting-type anorexia nervosa
Fecal Microbiome Transplant to Normalize Gut Microbiota, Metabolomics, Immunology, Cognitive and Affective Processing in Patients Suffering From Anorexia Nervosa
Researchers will try oral fecal microbiome transplant capsules in people with restricting-type anorexia nervosa to see if changing gut bacteria improves metabolism, immune health, and thinking about food and weight.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 16 Years to 35 Years |
| Sex | All |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's Academic / other |
| Locations | 1 site (London, Ontario) |
| Trial ID | NCT07143981 on ClinicalTrials.gov |
What this trial studies
This is a one-group, pre/post intervention study delivering fecal microbiome transplant (FMT) capsules to people with restricting-type anorexia nervosa before specialized eating-disorder treatment, with follow-up at 1 week, 3 weeks, and 3 months. The team will compare participants' gut microbiome diversity, targeted metabolomics, immune markers, and cognitive/affective measures before and after FMT. Participants must be medically stable adults with BMI <17 who can swallow capsules and are not on recent antibiotics or enrolled in refeeding programs. The goal is to determine acceptability and biological and cognitive changes associated with FMT in this population.
Who should consider this trial
Good fit: Adults meeting DSM-5 criteria for restricting-type anorexia nervosa with BMI <17 who are medically stable, can swallow capsules, read conversational English, are not pregnant, and have not used antibiotics or probiotics in the prior month are ideal candidates.
Not a fit: People with binge/purge type anorexia, active medical or psychiatric instability requiring hospitalization, chronic GI or immune disorders, recent antibiotic or probiotic use, pregnancy, or those currently enrolled in refeeding programs are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, FMT could diversify gut microbes, improve metabolic and immune profiles, and reduce distorted thinking about weight, potentially aiding recovery from anorexia.
How similar studies have performed: FMT has proven effective for some gastrointestinal conditions and shown preliminary signals in certain mental-health contexts, but applying FMT specifically to anorexia nervosa is novel and not previously established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * meet DSM 5 criteria for AN, restricting type, moderate or higher severity, as indicated by a BMI\<17 * Participants must we willing and able to swallow FMT capsules without vomiting * Able to read and understand conversational English Exclusion Criteria: 1. Medical or psychiatric instability needing hospitalization 2. Patients with AN binge/purge type 3. Use of antibiotics or probiotics in the month prior to treatment 4. Regular oral steroid use, or potent topical steroid use on large sections of skin 5. Chronic immune compromise and chronic illness affecting the intestinal tract or metabolic health 6. Pregnancy or intended pregnancy over the time of study 7. Patients enrolled in any treatment program that involves refeeding
Where this trial is running
London, Ontario
- London Health Sciences Research Institute — London, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Elizabeth Osuch — London Health Sciences Centre
- Study coordinator: Michael Wammes
- Email: michael.wammes@lhsc.on.ca
- Phone: 519-646-6000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.