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Study of gut microbiota and blood metabolomics in patients with mental disorders

Study of gut microbiota and blood metabolomics in patients with mental disorders

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500113261
Enrollment
Unknown
Registered
2025-11-26
Start date
2025-11-27
Completion date
Unknown
Last updated
2025-12-01

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

Conditions

Schizophrenia, depression, bipolar disorder, anxiety disorder

Interventions

Schizophrenia group:None
Depression group:None
healthy control group:None

Sponsors

Xijing Hospital, the Fourth Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
13 Years to 65 Years

Inclusion criteria

Inclusion criteria: Schizophrenia group 1. With the approval of the ethics committee, all participants (or guardians) shall sign a written informed consent form; 2. 200 patients with schizophrenia or schizophrenia like disorders who meet the DSM-5 diagnostic criteria; The total score of the Positive and Negative Syndrome Scale (PANSS) is >= 60 points; Age range: 13-65 years old; 3. Not using prebiotics, probiotics, and probiotic fermented foods within one month; 4. Not using any antibiotics within one month. Depression group 1. With the approval of the ethics committee, all participants (or guardians) shall sign a written informed consent form; 2. 200 patients with major depressive disorder who meet the DSM-5 diagnostic criteria; Hamilton Depression Rating Scale (HAMD) score >= 18 points; Age range: 13-65 years old; 3. Not using prebiotics, probiotics, and probiotic fermented foods within one month; 4. Not using any antibiotics within one month. Anxiety disorder group 1. With the approval of the ethics committee, all participants (or guardians) shall sign a written informed consent form; 2. 200 anxiety disorder patients who meet the DSM-5 diagnostic criteria; Hamilton Anxiety Scale (HAMA) score >= 14 points; Age range: 13-65 years old; 3. Not using prebiotics, probiotics, and probiotic fermented foods within one month; 4. Not using any antibiotics within one month. Bipolar disorder group 1. With the approval of the ethics committee, all participants (or guardians) shall sign a written informed consent form; 2. 200 patients with bipolar disorder who meet the DSM-5 diagnostic criteria (including current depressive episodes, hypomanic/manic episodes); During a depressive episode (HAMD) score >= 18 points; During manic episodes, the Young's Mania Scale (YMRS) score is >= 20 points; Age range: 13-65 years old; 3. Not using prebiotics, probiotics, and probiotic fermented foods within one month; 4. Not using any antibiotics within one month. Healthy control group 1. With the approval of the ethics committee, all participants (or guardians) shall sign a written informed consent form; 2. 100 healthy individuals aged 13-65 years old; 3. Not using prebiotics, probiotics, and probiotic fermented foods within one month; 4. Not using any antibiotics within one month.

Exclusion criteria

Exclusion criteria: 1. Presence of the following diseases: Gastrointestinal diseases: Inflammatory bowel disease, Crohn's disease, pancreatitis, fatty liver, etc. Coronary heart disease. Systemic autoimmune diseases (e.g., systemic lupus erythematosus, Behçet's disease, multiple sclerosis, connective tissue diseases). Atopic diseases (e.g., moderate to severe asthma, eczema, gastrointestinal eosinophilic disorders). Chronic pain syndromes (e.g., chronic fatigue syndrome, fibromyalgia). Neurological/neurodevelopmental disorders. 2. Obesity or metabolic abnormalities: Obesity: BMI >= 28.0. Hyperglycemia: Fasting plasma glucose (FPG) >= 6.1 mmol/L and/or 2-hour postprandial glucose (2hTC) >= 7.8 mmol/L and/or individuals who have been treated for diabetes. Hypertriglyceridemia: Triglycerides (TG) >= 2.3 mmol/L. Hypertension: Systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg. 3. Pregnant or breastfeeding women. 4. Individuals with special dietary or lifestyle preferences. 5. Presence of other psychiatric disorders that meet the diagnostic criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). 6. Use of any psychotropic medications or antipyretic analgesics within the past 2 weeks.

Design outcomes

Primary

MeasureTime frame
Diversity of gut microbiota;

Secondary

MeasureTime frame
Hamilton Anxiety Scale (HAMA);blood metabolomics;positive and negative syndrome scale;Hamilton Depression Scale;Yang's Mania Scale;

Countries

China

Contacts

Public ContactPeng Zhengwu

Xijing Hospital, the Fourth Military Medical University, Xi'an, China

pengzhengwu1446@163.com+86 137 2049 8280

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026