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Assessment of the Efficacy and Safety of Fecal Microbiota Transplantation (FMT) in Patients With Major Depressive Disorder

NCT06692361 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2025-12-02

No results posted yet for this study

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

Conditions

  • Major Depressive Disorder (MDD)
  • Depression - Major Depressive Disorder

Interventions

BIOLOGICAL

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.

DRUG

Escitalopram (Lexapro)

Both the experimental group and the placebo group were treated with the maximum tolerated dose of escitalopram.

BIOLOGICAL

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.

Sponsors & Collaborators

  • Shandong Daizhuang Hospital

    collaborator UNKNOWN

  • Tianjin Anding Hospital

    collaborator OTHER

  • The First Affiliated Hospital, Zhejiang University

    collaborator UNKNOWN

  • The First Hospital of Hebei Medical University

    collaborator OTHER

  • West China Hospital

    collaborator OTHER

  • Wuhu Fourth People's Hospital

    collaborator UNKNOWN

  • Gang Wang

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2026-06-30
Completion
2026-12-31

Countries

  • China

Study Locations

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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 NCT06692361 on ClinicalTrials.gov