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.
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
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
Parallel
Fecal Microbiota Transplant
Biological/VaccineAn investigational biologic comprised of 15.0g of dried healthy donor stool contained within a size 00 gelatin capsule, to be taken twice per day, twice per week over an 8-week duration.
Placebo
DrugOral placebo capsules (OPC) containing methylcellulose, to be taken twice per day, twice per week over an 8-week duration.
Recruitment Rate
The number of participants who are consented into the study divided by the number of participants who show interest in the study.
Retention Rate
The number of participants who completed the study divided by the number of participants consented into the study.
Attitudes towards Fecal Microbiota Transplant
Attitudes towards FMT will be studied via semi-structured qualitative interviews of all participants: the 20 adolescents and their parents in the trial, and the 10 adolescents and their parents who decline participation, and their guardians. Using Qualitative Description, interviews will explore patient and guardian attitudes toward FMT, as well as their impressions of efficacy (if they participated in the trial). Questions will include perceptions of "natural" versus "drug" products, perspectives on causes of AN, and interests in other potential treatments. Interviews will be conducted virtually, using Zoom for Healthcare, transcribed verbatim and then coded for themes using NVivo. This analysis stays close to the data with little to no interpretation. Our analysis will also include a summative content analysis.
Height
Height will be collected.
Weight
Weight will be measured between hospital visits using home weight scales provided to study participants.
Eating Disorder Examination Questionnaire
The EDEQ is a 28-item standardized questionnaire that measures the severity of symptoms of eating disorders, including menstrual status.
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Hamilton Health Sciences Corporation
Lead sponsor
McMaster University
Collaborator
Hamilton Academic Health Sciences Organization
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
