Using fecal microbiota transplants to treat anorexia nervosa
Feasibility Study of Using Fecal Microbiota Transplants (FMT) in Supportive Treatment of Anorexia Nervosa
This study is testing if giving fecal microbiota transplants from healthy donors to people with anorexia nervosa can help improve their symptoms by restoring a healthy gut microbiome.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Hvidovre University Hospital Academic / other |
| Locations | 3 sites (Ballerup and 2 other locations) |
| Trial ID | NCT05834010 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility of using fecal microbiota transplants (FMT) to treat anorexia nervosa (AN) by restoring the gut microbiome to a healthy state. The hypothesis is that prolonged undernutrition in AN alters the gut microbiome, contributing to the persistence of the disorder. By transplanting a healthy donor's gut microbiome into AN patients, the study aims to reboot the gut-brain axis, potentially improving symptoms and clinical outcomes. The pilot study will involve 20 AN patients, collecting microbiome samples and clinical data to assess changes in microbiome composition and diversity.
Who should consider this trial
Good fit: Ideal candidates for this study are women diagnosed with anorexia nervosa who are seeking treatment.
Not a fit: Patients under 18 years old or those with ongoing laxative abuse or certain chronic bowel disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel treatment option for patients with anorexia nervosa, potentially improving recovery rates.
How similar studies have performed: While the approach of using FMT in psychiatric disorders is novel, preliminary studies in related areas have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion: Women referred to the participating specialized centers or by advertising who fulfill the of a diagnosis of Anorexia Nervosa according to the criteria as specified in the Diagnostic and Statistical Manual of Mental Disorders(DSM) version 5. Exclusion: Age \<18 years. Known ongoing abuse of laxatives. Antibiotic treatment within the last three months. Probiotics within the last month Inflammatory bowel disease, colorectal cancer or other known chronic bowel disorder
Where this trial is running
Ballerup and 2 other locations
- Psychiatric Centre Ballerup — Ballerup, Denmark (Recruiting)
- Copenhagen University Hospital Hvidovre — Hvidovre, Denmark (Recruiting)
- Odense University Hospital — Odense, Denmark (Recruiting)
Study contacts
- Study coordinator: kenneth K barfod, phd cand.scient.bio
- Email: kenneth.barfod@food.ku.dk
- Phone: +45 60777016
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.