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NOT YET RECRUITING
NCT06593366
NA

Fecal Microbiota Transplant for Anorexia Nervosa

Sponsor: McMaster University

View on ClinicalTrials.gov

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 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.

Official title: A Pilot Feasibility Randomized Controlled Trial of Fecal Microbiota Transplant for Adolescent Anorexia Nervosa

Key Details

Gender

FEMALE

Age Range

12 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2025-01-01

Completion Date

2026-06

Last Updated

2024-11-22

Healthy Volunteers

No

Interventions

BIOLOGICAL

Fecal Microbiota Transplant

An 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.

DRUG

Placebo

Oral placebo capsules (OPC) containing methylcellulose, to be taken twice per day, twice per week over an 8-week duration.