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The comparison of intestinal flora species and metabolites in Chinese patients with schizophrenia, depression and bipolar disorder

The comparison of intestinal flora species and metabolites in Chinese patients with schizophrenia, depression and bipolar disorder

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ROC-17013029
Enrollment
Unknown
Registered
2017-10-19
Start date
2017-11-01
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

schizophrenia, depression, bipolar disorder

Interventions

schizophrenia group:without
depression group:without
bipolar disorder group:without

Sponsors

The department of psychiatry, Xijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 65 Years

Inclusion criteria

Inclusion criteria: Schizophrenia group: 1. Subject to consent by Drug Clinical Trials Ethics Committee of the First Affiliated Hospital, Fourth Military Medical University. The guardian of all participants need to sign a written informed consent; 2. 100 patients with schizophrenia or schizophrenia-like disorder who meet the DSM-5 diagnostic criteria will be recruited from outpatients or inpatients at the First Affiliated Hospital of Fourth Military Medical University; the score of Positive and negative symptoms scale (PANSS) is greater than or equal to 60; Aged 16 to 65; 3. Did not use probiotics and probiotic fermented food within 1 mouth; 4. Did not use any antibiotics within 1 month. Depression group: 1. Subject to consent by Drug Clinical Trials Ethics Committee of the First Affiliated Hospital, Fourth Military Medical University. All participants (or guardians) need to sign a written informed consent; 2. 100 patients with major depressive disorder who meet the DSM-5 diagnostic criteria will be recruited from outpatients or inpatients at the First Affiliated Hospital of Fourth Military Medical University; the score of HAMD is greater than or equal to 18; Aged 16 to 65 years; 3. Did not use probiotics and probiotic fermented food within 1 mouth; 4. Did not use any antibiotics within 1 month. Bipolar disorder group: 1. Subject to consent by Drug Clinical Trials Ethics Committee of the First Affiliated Hospital, Fourth Military Medical University. All participants (or guardians) need to sign a written informed consent; 2. 100 patients (50 cases of depressive episodes, 50 cases of hypomania or manic episodes) with bipolar disorder who meet the DSM-5 diagnostic criteria will be recruited from outpatients or inpatients at the First Affiliated Hospital of Fourth Military Medical University; HAMD score >= 18 points or YMRS score >= 20 points; Aged 16 to 65 years; 3. Did not use probiotics and probiotic fermented food within 1 mouth; 4. Did not use any antibiotics within 1 month. Control group: 1. Subject to consent by Drug Clinical Trials Ethics Committee of the First Affiliated Hospital, Fourth Military Medical University. All participants (or guardians) need to sign a written informed consent; 2. 100 subjects aged 16 to 65 years old will be recruited from physical examination center of the First Affiliated Hospital, Fourth Military Medical University; 3. Did not use probiotics and probiotic fermented food within 1 mouth; 4. Did not use any antibiotics within 1 month.

Exclusion criteria

Exclusion criteria: 1. Patients with inflammatory bowel disease, crohn's disease or other diseases of the digestive system, patients with other organic diseases; 2. Obesity: BMI >= 28.0; hyperglycemia: FPG >= 6.1mmol/L and/or somebody has been diagnosed with diabetes and treatment; TG >= 2.3 mmol/L; hypertension: systolic >= 140mmHg or diastolic blood pressure >= 90mmHg; 3. Pregnant or lactating women; 4. Severely unbalanced diet, such as high-fat diet or long-term vegetarians; 5. Suffering from other mental disorders in line with DSM-5 diagnostic criteria; 6. Taken any kind of psychotropic drugs or antipyretic analgesics in sufficient doses for more than 2 days in the nearly two weeks.

Design outcomes

Primary

MeasureTime frame
Fecal Sample Test;Hamilton depression scale;Young manic rating scale;positive and negative syndrome scale;

Secondary

MeasureTime frame
Global Assessment Function;

Countries

China

Contacts

Public ContactHuaning Wang

Department of psychiatry, Xijing Hospital

xskzhu@fmmu.edu.cn+86 13609161341

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 25, 2026