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

• Status: Not yet recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital Xi'an Jiaotong University

Criteria

Inclusion Criteria:

• Aged from 18 to 65 years

• Patients with schizophrenia and a disease duration of 5 years or less are currently receiving first-line recommended antipsychotic medications

• The patients met the diagnostic criteria of schizophrenia in the 10th edition of the International Classification of Diseases (ICD-10)

• Positive and Negative Syndrome Scale (PANSS) : total score ≥60 (at least 3 positive items ≥3 or 3 negative items ≥3)

• Junior high school or above

• Subjects provided informed consent

Exclusion Criteria:

• Pregnant and lactating women

• Clinically significant or unstable medical diseases, including congestive heart failure, liver and kidney failure, cancer, immune and metabolic endocrine diseases

• Or hepatobiliary gastrointestinal diseases, abdominal pain, diarrhea (except functional constipation)

• Those who had acute or chronic infection, had taken anti-inflammatory drugs, cortisol hormones, and had received antibiotics in the past month

• Other neuropsychiatric disorders (patients with organic brain lesions, mental disorders and mental retardation caused by physical diseases or psychoactive substances)

• There were those with fixed drinking habits

• It is accompanied by intestinal diseases that seriously damage the intestinal barrier, such as inflammatory bowel disease, Crohn's disease, intestinal tuberculosis, ischemic bowel disease, radiation enteritis, and intestinal infectious diseases