NCT02708316

The Gut Metagenome Research of Schizophrenia

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: First Affiliated Hospital Xi'an Jiaotong University · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Research already found that patients with autistic spectrum disorders lack of Prevotella intestinal type, then schizophrenia patients may also show the specific intestinal type, so investigators want to detect the gut metagenome of schizophrenia patients by high-throughput DNA sequencing to find specific intestinal type, so as to achieve the purpose of schizophrenia diagnosis. According to the detection of inflammatory factors in the blood, nerve growth factor in the cerebrospinal fluid, to find the mechanism of the gut-microbes-brain axis. Furthermore, investigators want to identify intestinal strains involved in weight gain and metabolic disorders such as blood glucose and lipids induced by antipsychotic drugs.

Detailed description

A prospective observational study will be conducted and cases will be recruited by multi-center cooperation. Investigators plan to collect 100 schizophrenic patients as case group, 100 healthy people as control group. Investigators will observe schizophrenia patients who use the single drug of risperidone in the treatment and follow up the patients on day 1, the third week, the third month, the sixth month and the first year. In addition, the other two groups of patients with schizophrenia will be included, one with olanzapine and the other with aripiprazole. There are three objectives: 1. Compare healthy population with schizophrenia patients in the difference of gut metagenome and inflammatory factors in the blood, stool samples aimed at detecting the difference of composition of intestinal microorganism; 2. Observe the change of intestinal microorganism, inflammatory factors, γ-aminobutyric acid of schizophrenic patients who received risperidone treatment according to the blood, stool samples, cerebrospinal fluid during the follow-up period. 3. Study the difference of intestinal flora composition between schizophrenia patients with metabolic disorder and schizophrenia patients without metabolic disorder after olanzapine or aripiprazole treatment and discuss the relationship between intestinal flora composition and metabolic disorder.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
GENETIC	sequencing faecal metagenome	sequencing faecal metagenome is not the intervention measure.It is the observational method for investigators to detect the component of faecal microorganism.

Timeline

• Start date: 2016-04-01
• Primary completion: 2022-12-01
• Completion: 2022-12-01
• First posted: 2016-03-15
• Last updated: 2021-08-19

Locations

1 site across 1 country: China