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A Study on the Effects of Combined FMT on Gut Microbiota and Eating Disorder Symptoms in AN

NCT06744751 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-08-19

No results posted yet for this study

Summary

The goal of this clinical trial is to determine if Fecal Microbiota Transplantation (FMT) is effective in treating Anorexia Nervosa (AN). The study will also explore how FMT works. The main questions it aims to answer are:

1. What is the efficacy of combined FMT treatment in patients with AN?
2. What is the relationship between treatment efficacy and changes in gut microbiota, and what mechanisms underlie the effects of FMT in treating AN? Researchers will compare FMT to a placebo (a look-alike substance that contains no active ingredients) to see if FMT is effective in treating AN.

Participants will:

* Be hospitalized
* Take FMT or placebo daily for 6 days
* Provide stool and blood samples before and after FMT
* Visit the clinic every 4 weeks for check-ups and tests

Conditions

  • Anorexia Nervosa

Interventions

BIOLOGICAL

Fecal Microbiota Transplantation

Patients take the capsules twice daily, with a dose of 6 or 10 capsules per day, for a total of 6 days (72 or 120 capsules in total). Select the capsule dosage based on age. For children under 18 years old, take 10 capsules at a time. For adults aged 18 and above, take 6 capsules at a time. Both the FMT and placebo capsules are identical in appearance, size, color, form, weight, and taste, with the placebo containing starch as the main ingredient.

DRUG

Placebo

Manufactured by the same company, the placebo capsules contain starch as the main ingredient and are identical in appearance, size, color, dosage form, weight, and taste to the FMT capsules. They are administered twice daily, 6 or 10 capsules per dose (selected by age), for 6 days.

Sponsors & Collaborators

  • Shanghai Mental Health Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-12-30
Completion
2027-12-31

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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 NCT06744751 on ClinicalTrials.gov