NCT05850585Not yet recruiting
A Study of the Efficacy of Fecal Microbiota Transplantation(FMT) in the Treatment of Schizophrenia
A Prospective, Double-blind, Randomized Controlled Trial of FMT Combined With Antipsychotic Drugs to Improve the Efficacy of Schizophrenia
Source: ClinicalTrials.gov · Last updated 26 May 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 12 Apr 2023
- Start date
- 1 Jul 2023
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong University
- Diseases
- Schizophrenia
- NCT number
- NCT05850585
What you commit to
- Study type: Interventional
- Planned participants: 100
- From 1 Jul 2023 to the primary completion date, 31 Dec 2025
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Those who had acute or chronic infection, had taken anti-inflammatory drugs, cortisol hormones, and had received antibiotics in the past month
Other illness
- 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)
- Other neuropsychiatric disorders (patients with organic brain lesions, mental disorders and mental retardation caused by physical diseases or psychoactive substances)
- 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
Other
- Pregnant and lactating women
- There were those with fixed drinking habits
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.