Bipolar Disorder
Conditions
Interventions
Bifidobacterium group:Live Combined Bifidobacterium,Lactobacillus and Enterococcus Capsules
Sponsors
Second Xiangya Hospital, Central South University.
Eligibility
Sex/Gender
All
Age
18 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) Bipolar Disorder Diagnostic Criteria and is reviewed by the Mini-SCID diagnostic interview tool; 4. The main clinical phase is one of the following (first or recurrent): Manic phase: YMRS scale =12, HAM-D17<17, Depressive phase: YMRS scale <12, HAM-D17 = 17, Mixed phase: YMRS scale = 12, HAM-D17 = 17; 5. The total disease duration is =5 years, and the current drug regimen is olanzapine alone, valproate alone, olanzapine + valproate, or the planned drug plan after enrollment is one of the above; 6. 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
| Measure | Time frame |
|---|---|
| Body weight;Fasting plasma glucose;Total cholesterol;Bone density;YMRS;HAM-D17; | — |
Secondary
| Measure | Time frame |
|---|---|
| CGI-S, CGI-I, HAMA, Self-rating scale; | — |
Countries
China
Contacts
Public ContactJindong Chen
Second Xiangya Hospital, Central South University
Outcome results
None listed