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.
Who can participate
Age range12 Years – 17 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
What they're measuring
1
Recruitment Rate
Timeframe: Through study completion, an average of one year.
2
Retention Rate
Timeframe: Through study completion, an average of one year.