drugset / Trial / NCT05850585

A Study of the Efficacy of Fecal Microbiota Transplantation(FMT) in the Treatment of Schizophrenia

NCT05850585

Not yet recruiting 100 enrolled First Affiliated Hospital Xi'an Jiaotong University
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2023-07
Primary completion
2025-12
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Ornidazole Other / unclassified 1e+12 unknown Oral

Indications