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The effect of Probiotics Probio-M8 on schizophrenia

The effect of Probiotics Probio-M8 on schizophrenia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109122
Enrollment
Unknown
Registered
2025-09-12
Start date
2024-08-01
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Schizophrenia

Interventions

Placebo group:Placebo

Sponsors

The Third Hospital of Inner Mongolia Autonomous Region
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Meets ICD-10 diagnostic criteria for schizophrenia with a duration of at least 2 years; 2. Positive and Negative Symptom Scale (PANSS) total score >= 60 points; 3. Prior to study enrollment, patients must have taken atypical antipsychotic medication for at least 8 weeks with no medication changes within 21 days; 4. Age between 20 and 70 years; 5. Consent to participate in this study and sign an informed consent form; 6. Patients must be conscious and able to cooperate with examinations, questionnaires, and medical history collection independently or with family assistance. 7. Failure to meet any of the above requirements will result in exclusion from the clinical study.

Exclusion criteria

Exclusion criteria: 1. Individuals with other mental disorders such as organic brain disorders or affective disorders; 2. Those with severe physical illnesses or conditions that may interfere with assessment; 3. Individuals with a history of substance abuse or dependence within the past year; 4. Participants who discontinue or arbitrarily adjust the study medication during follow-up; 5. Individuals with a history of severe suicidal ideation; 6. Those with hearing or visual impairments; 7. Concurrent use of laxatives during follow-up, such as polyethylene glycol electrolyte solutions, phenolphthalein tablets, or senna leaf preparations; 8. Patients with chronic digestive system diseases or tumors, such as peptic ulcers, inflammatory bowel disease, or severe liver disease; 9. Patients with allergy to the study drug or experiencing significant gastrointestinal symptoms such as intolerance; 10. Patients with irregular dietary habits or significant changes in diet during follow-up.

Design outcomes

Primary

MeasureTime frame
Positive and Negative Syndrome;Minimum Mental State Examination;

Secondary

MeasureTime frame
Fecel metagenomics;Fecel metabolomics;Blood biochemistry;Inflammatory factor;

Countries

China

Contacts

Public ContactZhijian Bai

The Third Hospital of Inner Mongolia Autonomous Region

70280256@qq.com+86 180 0481 3300

Outcome results

None listed

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