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

Sponsor
Shanghai Mental Health Center
Study ID
NCT06744751
Status
Not Yet Recruiting

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Conditions

  • Anorexia Nervosa

Eligibility Criteria

Sex
FEMALE
Age
12 Years - 35 Years
Healthy Volunteers
Not accepted

Interventions

  • Fecal Microbiota Transplantation — BIOLOGICAL
    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.
  • Placebo — DRUG
    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.

Study Details

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

Key Dates

First listed
Dec 20, 2024
Start date
Sep 1, 2025
Status verified
Jul 2025
Primary completion
Dec 30, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Fecal Microbiota Transplantation
    The FMT capsules used in this study contain processed, frozen stool from healthy donors, providing gut microbiota from these individuals. The FMT capsules meet relevant manufacturing standards. Patients take the capsules twice daily, with a dose of 6 or 10 capsules per day, over a period of 6 days (for a total of 72 or 120 capsules). 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.
  • Placebo Comparator: Placebo
    The placebo capsules, manufactured by the same company, are identical in appearance, size, color, dosage form, weight, and taste to the FMT capsules. Starch is used as the main ingredient to mimic the FMT capsules.

Primary Outcome Measure

Hight [ Time Frame: baseline，follow-up (4,8,12 week) ]

Central Contacts

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