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A Study on the Effects of Combined FMT on Gut Microbiota and Eating Disorder Symptoms in AN
Sponsor: Shanghai Mental Health Center
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
Official title: A Randomsized Controlled Study on the Effects of Combined Fecal Microbiota Transplantation on Gut Microbiota and Eating Disorder Symptoms in Patients With Anorexia Nervosa
Key Details
Gender
FEMALE
Age Range
12 Years - 35 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2025-09-01
Completion Date
2027-12-31
Last Updated
2025-08-19
Healthy Volunteers
No
Conditions
Interventions
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.
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.