The Gut Metagenome Research of Schizophrenia

NCT02708316 | Unknown

• 1 other identifier: XJTU1AF-CRS-2015-009
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (2)

• species-level molecular operational taxonomic units

  The composition of the gut microbe was evaluated by sequencing faecal metagenome. The specific measures representing the above characteristics of gut microbe contain species-level molecular operational taxonomic units.

  at the beginning

• species-level molecular operational taxonomic units

  The composition of the gut microbe was evaluated by sequencing faecal metagenome. The specific measures representing the above characteristics of gut microbe contain species-level molecular operational taxonomic units.

  the third month

Secondary Outcomes (15)

• concentration of inflammatory factors

  at the beginning

• concentration of inflammatory factors

  the third week

• concentration of inflammatory factors

  the third month

• concentration of inflammatory factors

  the sixth month

• concentration of inflammatory factors

  one year

Study Arms (2)

schizophrenia group

schizophrenia patients in the group

Genetic: sequencing faecal metagenome

control group

healthy population

Genetic: sequencing faecal metagenome

Interventions

sequencing faecal metagenome GENETIC

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

control group; schizophrenia group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The cases included the first episode or recurrent acute-exacerbation schizophrenia patients who correspond to the DSM-Ⅵ diagnostic criteria. The healthy population is matched with cases based on gender, age, nationality, smoking, diet, education and socioeconomic status.

You may qualify if:

• The first episode or recurrent acute-exacerbation schizophrenia patients who correspond to the Diagnostic and Statistical Manual of Mental Disorders-Ⅵ (DSM-Ⅵ) diagnostic criteria.
• Between 18 and 45 years old (including 18 and 45 years old, male or female).
• Patients never accepted full range of psychotropic drugs before admission(taking psychotropic drug less than 5 days before admission)
• the duration of recurrent patients is less than 5 years
• the period of taking psychiatric drug before admission is no more than 2 weeks.
• didn't use of antibiotics within consecutive 3 days in recent 3 months.
• meet the indications of a single antipsychotic risperidone treatment.
• All the patients must have a good family support and comply with the requirements and signed informed consent
• The PANSS score is greater than 60 or equal to 60.
• BMI is greater than or equal 17.5 and less than or equal to 30.

You may not qualify if:

• Patients have severe unstable cardiovascular disease, liver disease, kidney disease, blood disease and endocrine disease or history.
• Patients have the history of systematic disease or history of malignant tumor or relevant complications.
• Patients have the activity of gastrointestinal diseases.
• Patients have organic brain disease or complications and mental retardation.
• According to the DSM-Ⅵ diagnostic criteria , patients have drug abuse or drug dependence and incomplete remission.
• glutamic-oxalacetic transaminase (AST) or glutamic-pyruvic transaminase (ALT) is 2 times higher than the normal limit.
• Renal dysfunction, creatinine is higher than the upper limit of normal value.
• The women in pregnancy or lactation now, and may be in pregnant during the study period.
• Patients are allergic to risperidone.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead
• Rehabilitation Hospital of Bao Ji City: collaborator
• Center Hospital of Xian Yang City: collaborator
• Mental Health Center of Wei Nan City: collaborator

Study Sites (1)

First Affiliated Hospital of Xian Jiaotong University

Xi'an, Shaanxi, 710061, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

stool samples retained for sequencing faecal metagenome

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Xiancang Ma, MD,PHD

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiancang Ma, MD,PHD

CONTACT

008613002951782; maxiancang@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2016
• First Posted: March 15, 2016
• Study Start: April 1, 2016
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: August 19, 2021

Record last verified: 2021-08

Locations

CN (1)