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A Study of the Efficacy of Fecal Microbiota Transplantation(FMT) in the Treatment of Depression
Sponsor: First Affiliated Hospital Xi'an Jiaotong University
Summary
Patients with depression were enrolled and randomly divided into two groups, namely FMT combined with antidepressant group and Antidepressant alone group.The former received FMT capsules and antidepressants, and the latter received oral placebo and antidepressants for an 8-week intervention.Before and after intervention, venous blood samples were collected from patients for routine tests such as liver and kidney function to judge the safety of treatment. At the same time, psychological scales were used to evaluate the improvement of patients' depressive symptoms, so as to judge the efficacy and safety of FMT combined with antidepressants.
Official title: A Prospective, Double-blind, Randomized Controlled Trial of FMT Combined With Antidepressants to Improve the Efficacy in Patients With Depressive Disorder
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2023-07
Completion Date
2026-12
Last Updated
2023-05-30
Healthy Volunteers
No
Conditions
Interventions
Fecal microbiota transplantation(FMT)
Subjects will receive FMT capsules (10\^12 CFU/capsule) in addition to their usual antidepressant treatment. Subjects will continue to receive FMT capsules for 8 weeks. New SSRI antidepressants (fluoxetine, citalopram, escitalopram, sertraline, paroxetine, and fluvoxamine) recommended by current treatment guidelines can be used during this period, and the effective therapeutic dose of the drugs can be added within 1 week.
Placebo
Participants will receive a placebo capsule with the same color, appearance, and smell as the FMT capsule, in addition to their usual antidepressant treatment. Placebo capsules contained the food probiotic Lactobacillus (10\^12 CFU per capsule). Subjects will continue to receive placebo capsules for 8 weeks. New SSRI antidepressants (fluoxetine, citalopram, escitalopram, sertraline, paroxetine, and fluvoxamine) recommended by current treatment guidelines can be used during this period, and the effective therapeutic dose of the drugs can be added within 1 week.