Status:
NOT_YET_RECRUITING
Fecal Microbiota Transplant for Anorexia Nervosa
Lead Sponsor:
McMaster University
Conditions:
Anorexia Nervosa Restricting Type
Anorexia Nervosa
Eligibility:
FEMALE
12-17 years
Phase:
NA
Brief Summary
The purpose of this pilot randomized-controlled trial is to determine whether Fecal Microbiota Transplant (FMT) treatment demonstrates feasibility, acceptability, and prelinary effectiveness among pat...
Detailed Description
In the following pilot randomized-controlled trial, the investigators' aim is to determine whether FMT treatment demonstrates feasibility, acceptability, and preliminary effectiveness in pediatric AN ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06593366
Start Date
January 1 2025
End Date
June 1 2026
Last Update
November 22 2024
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