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Assessment of the Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in Patients With Major Depressive Disorder
Sponsor: Gang Wang
Summary
This study aimed to evaluate the efficacy and safety of fecal microbiota transplantation (FMT) in patients with major depressive disorder (MDD) who exhibit suboptimal early response to antidepressant treatment. Additionally, it sought to investigate the impact of FMT on biological indicators, including intestinal microbiota and metabolites, in individuals with MDD
Official title: Assessment of the Effectiveness and Safety of Fecal Microbiota Transplantation (FMT) in Patients With Major Depressive Disorder Who Do Not Show Early Improvement Following Antidepressant Treatment: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
214
Start Date
2025-01-01
Completion Date
2026-12
Last Updated
2025-12-02
Healthy Volunteers
No
Interventions
FMT capsule
The experimental group will maintain escitalopram treatment and take 1.0 g of FMT capsules orally with breakfast every day for 4 weeks.
Escitalopram (Lexapro)
Both the experimental group and the placebo group were treated with the maximum tolerated dose of escitalopram.
Corn Starch capsules
The placebo group will maintain escitalopram treatment and take corn starch capsules 1.0 g orally with breakfast every day for 4 weeks.
Locations (9)
Wuhu Fourth People's Hospital
Wuhu, Anhui, China
Beijing Anding Hospital
Beijing, Beijing Municipality, China
Nangfang Hospital Affiliated of Southern Medical University
Guangzhou, Guangdong, China
The First Affiliated Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Shandong Daizhuang Hospital
Jining, Shandong, China
West China Hospital Affiliated of Sichuan University
Chengdu, Sichuan, China
Tianjin Anding Hospital
Tianjin, Tianjin Municipality, China
The Second People's Hospital of Dali Bai Autonomous Prefecture
Dali, Yunnan, China
The First Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, China