NCT07143981 The Fecal Microbiome Transplant (FMT) Study for Anorexia Nervosa
| NCT ID | NCT07143981 |
| Status | Recruiting |
| Phase | — |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's |
| Condition | Anorexia Nervosa |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-01-15 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2026-01-15 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Anorexia Nervosa (AN) is a severe, debilitating and potentially life threatening illness that is difficult to treat. A cardinal symptom of AN is the mistaken belief on the part of the individuals that they are overweight and must continue to restrict intake. This fixed false belief is a detrimental factor to recovery. It is known that AN involves disturbance in the gut microbiome (GM; the microbes that live in the lower intestinal tract). The GM also affects how one thinks and makes food choices - there appears to be a direct link between the GM and how the brain functions. This connection is thought to occur through chemical processes that convey information from the gut to the brain. It is known that fecal microbiome transplant (FMT) has been useful in treating several illnesses, including several mental illnesses. The investigators intend to deliver FMT to individuals with AN to determine the extent to which this modifies their GM, their biochemistry, their thinking processes and their moods and emotions. The investigators believe this will illuminate important aspects of AN that keep the illness in place, and that this will uncover useful approaches to better treat it.
Eligibility 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
Contact & Investigator
Elizabeth Osuch
PRINCIPAL INVESTIGATOR
London Health Sciences Centre
Frequently Asked Questions
Who can join the NCT07143981 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, up to 35 Years, studying Anorexia Nervosa. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07143981 currently recruiting?
Yes, NCT07143981 is actively recruiting participants. Contact the research team at michael.wammes@lhsc.on.ca for enrollment information.
Where is the NCT07143981 trial being conducted?
This trial is being conducted at London, Canada.
Who is sponsoring the NCT07143981 clinical trial?
NCT07143981 is sponsored by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's. The principal investigator is Elizabeth Osuch at London Health Sciences Centre. The trial plans to enroll 20 participants.