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

The main research content of this project is to observe the efficacy and safety of adjuvant FMT capsules in the treatment of schizophrenia by enrolling patients with schizophrenia and randomly administering FMT combined with antipsychotics or placebo combined with antipsychotics. This is a multicenter, randomized, double-blind, placebo-controlled clinical trial. In this study, patients with schizophrenia were randomly divided into two groups. The first group was the experimental group, and FMT capsules (10\^12 CFU/ capsule) were used in addition to conventional antipsychotic drugs. The other group, a control group, received a placebo pill with the same color, appearance and smell as the FMT capsules in addition to regular antipsychotic medication. Placebo capsules contain Lactobacillus probiotics for food use (10\^12 CFU/ capsule). To observe the efficacy and safety of adjuvant FMT capsule in patients with schizophrenia. The subjects (inpatients) were evaluated for meeting the eligibility requirements for this study according to the pre-specified inclusion and exclusion criteria, and demographic data (age, sex, marital status, educational level, employment, height and weight, smoking and drinking, and other general information as well as questionnaire assessment of eating habits) were collected. Improve laboratory examination (blood routine, liver function, kidney function and lipid), electrocardiogram and scale assessment. Patients at the end of the screening period were randomly assigned to the experimental and control groups. Subjects will continue to receive FMT capsules or placebo capsules until the end of 8 weeks. During this period, both groups were given first-line atypical antipsychotics (clozapine, olanzapine, quintiapine, risperidone, aripiprazole, Ziprasidone, amsulapride, paliperidone, and paliperidone palmitate) recommended by current treatment guidelines, and added to the effective therapeutic dose within 1 week. Benzodiazepines and drugs that ameliorate side effects of antipsychotics may be used during the study period. Antidepressants and mood stabilizers are prohibited. Transcranial magnetic stimulation and electronic biofeedback were allowed during the study, and non-convulsive electroconvulsive therapy was prohibited.