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A Study of the Efficacy of Fecal Microbiota Transplantation(FMT) in the Treatment of Schizophrenia
Sponsor: First Affiliated Hospital Xi'an Jiaotong University
Summary
The purpose of this study was to explore whether repeated oral fecal capsules could improve outcomes in patients with schizophrenia receiving conventional antipsychotic drugs. This study was divided into screening period (1 week) and treatment period (8 weeks). Subjects who met the inclusion criteria during the screening period entered the treatment period. During the treatment period, the patients were divided into two groups: oral fecal bacteria capsules + antipsychotics group; Oral placebo + antipsychotic group. During the follow-up period, both groups were treated with stable dose of antipsychotic drugs during the treatment period. Before and after the intervention, venous blood samples of patients were collected for routine tests such as liver and kidney function to determine the safety of treatment. The scale evaluated the improvement of patients' psychotic symptoms to determine the efficacy and safety of FMT combined with antipsychotics.
Official title: A Prospective, Double-blind, Randomized Controlled Trial of FMT Combined With Antipsychotic Drugs to Improve the Efficacy of Schizophrenia
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
2023-05-26
Healthy Volunteers
No
Conditions
Interventions
Fecal microbiota transplantation(FMT)
Subjects will receive FMT capsules (10\^12 Colony-Forming Units(CFU)/capsule) in addition to their usual antipsychotics treatment. Subjects will continue to receive FMT capsules for 8 weeks. During this period, both groups could receive first-line atypical antipsychotics recommended by current treatment guidelines.
Placebo
Participants will receive a placebo capsule with the same color, appearance, and smell as the FMT capsule, in addition to their usual antipsychotics treatment. Placebo capsules contained the food probiotic Lactobacillus (10\^12 CFU per capsule). Subjects will continue to receive placebo capsules for 8 weeks. During this period, both groups could receive first-line atypical antipsychotics recommended by current treatment guidelines.