MedTrace Logo

Fecal Microbiota Transplant for Anorexia Nervosa

NCT06593366 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-11-22

No results posted yet for this study

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.

Conditions

  • Anorexia Nervosa Restricting Type
  • Anorexia Nervosa
  • Anorexia in Adolescence
  • Anorexia in Children
  • Anorexia

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.

Sponsors & Collaborators

Principal Investigators

  • Jennifer L Couturier, MD, MSc · McMaster University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
17 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2026-06-30
Completion
2026-06-30

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06593366 on ClinicalTrials.gov