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The efficacy, safety and related mechanisms of bifidobacteria in the adjuvant treatment of mental disorder

The efficacy, safety and related mechanisms of bifidobacteria in the adjuvant treatment of mental disorder

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900024126
Enrollment
Unknown
Registered
2019-06-26
Start date
2019-07-01
Completion date
Unknown
Last updated
2019-07-01

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

Conditions

Mental disorder

Interventions

Experimental group:Bifidobacterium triple live capsule

Sponsors

Second Xiangya Hospital, Central South University.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 55 Years

Inclusion criteria

Inclusion criteria: 1. Subjects voluntarily participated in the trial and signed informed consent and were able to comply with the planned visits, laboratory tests and other research procedures; 2. Outpatients or inpatients of men and women aged 18 to 55 years; 3. Meet the Diagnostic and Statistical Manual of Mental Disorder-V (DSM-V) Major Depression Disorder or Bipolar Disorder Diagnostic Criteria and is reviewed by the Mini-SCID diagnostic interview tool; 4. From the signing of informed consent to the end of the trial, there will be no major changes in the diet structure.

Exclusion criteria

Exclusion criteria: 1. There are other serious somatic diseases or comorbid diseases, especially patients who are undergoing diabetes treatment or lipid-regulating therapy; patients with history of cardiovascular and cerebrovascular diseases such as coronary heart disease and cerebral infarction; 2. Meet other diagnosis of mental diseases; 3. Patients who are taking benzodiazepines daily. Patients received ECT within 6 months or need ECT in current episodes; 4. Women during pregnancy or breastfeeding, or have plan during the trial period, and women at high risk of pregnancy who have not taken any contraceptive measures; 5. There are obvious suicide attempts or behaviors; 6. Other conditions or drugs that may affect biomarkers during the trial: long-term regular administration of NSAIDs, COX-2 inhibitors, immunosuppressants, hormone drugs, interferons, chemotherapeutics, anticoagulants Etc. Malignant tumors, active autoimmune diseases, inflammatory bowel diseases, etc.; 7. Bifidobacterium triple live capsule allergy history; 8. Had a history of digestive surgery; 9. History of the use of antibiotics in the last 1 week.

Design outcomes

Primary

MeasureTime frame
Bone density;HAMD;HAMA;Total cholesterol;Fasting plasma glucose;

Countries

China

Contacts

Public ContactHaishan Wu

Second Xiangya Hospital, Central South University

wuhaishan@csu.edu.cn+86 13755058944

Outcome results

None listed

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