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

NCT05850585 | Not Yet Recruiting

• 2 other identifiers: 82022023-22021GXLH-Z-083-2
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (3)

• Positive and Negative Syndrome Scale（PANSS）score

  PANSS is a scale used to assess the psychotic symptoms of the client.This scale is evaluated by trained doctors, usually through conversation and observation, and scored after the examination. Score before and after treatment and during treatment can evaluate the severity of the disease and treatment effect.

  At the beginning of treatment, at 4 weeks and at the end of 8 weeks

• Positive and Negative Syndrome Scale（PANSS）score

  PANSS is a scale used to assess the psychotic symptoms of the client.This scale is evaluated by trained doctors, usually through conversation and observation, and scored after the examination. Score before and after treatment and during treatment can evaluate the severity of the disease and treatment effect.

  at the end of 4 weeks

• Positive and Negative Syndrome Scale（PANSS）score

  PANSS is a scale used to assess the psychotic symptoms of the client.This scale is evaluated by trained doctors, usually through conversation and observation, and scored after the examination. Score before and after treatment and during treatment can evaluate the severity of the disease and treatment effect.

  at the end of 8 weeks

Study Arms (2)

Fecal microbiota transplantation(FMT)

EXPERIMENTAL

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.

Drug: Fecal microbiota transplantation(FMT)

Placebo

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Fecal microbiota transplantation(FMT) DRUG

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.

Fecal microbiota transplantation(FMT)

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

MeSH Terms

Conditions

Schizophrenia

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Feng Zhu, professor

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY DIRECTOR

Central Study Contacts

Feng Zhu, professor

CONTACT

0086-13571827380; zhufeng0714@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: May 9, 2023
• Study Start: July 1, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 26, 2023

Record last verified: 2023-04