Fecal Microbiota Transplant for Anorexia Nervosa

Launched by MCMASTER UNIVERSITY · Sep 9, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a treatment called Fecal Microbiota Transplant (FMT) for young people with anorexia nervosa, a serious eating disorder. The main goal of the study is to see if FMT can help improve weight, mood, and other health markers by changing the bacteria in the gut. Researchers will compare two groups of participants: one group will receive the FMT treatment, while the other group will receive a placebo, which is an inactive substance.

To be eligible for the study, participants need to be girls aged 12 to 17 who have been diagnosed with anorexia nervosa and have a weight that is below 85% of their treatment goal. They must also be active patients in the pediatric eating disorder program at the medical center. During the trial, participants can expect to undergo various health assessments, including checks on their weight and mood, while receiving either the FMT treatment or placebo. It's important to note that certain conditions, like pregnancy or recent use of antibiotics, may prevent someone from joining the study. This trial is not yet recruiting, so interested individuals or their families should keep an eye out for more information as it becomes available.

Gender

FEMALE

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)