bipolar disorder
Conditions
Interventions
treatment group:taking probiotics + conventional treatment
controll group:taking placebo + conventional treatmen
Sponsors
The Second Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
16 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Age 16-45 years; 2. Met the International Statistical Classification of Diseases and Related Health Problems, 10th revision (ICD-10) diagnostic criteria for depressive BD-I; 3. 17-item Hamilton Depression Rating Scale (HAMD-17) score > 17.
Exclusion criteria
Exclusion criteria: 1. With suicide ideations or/and suicidal behaviors; 2. With positive symptoms of psychosis, such as delusions and hallucinations; 3. With the presence of a personality disorder; 4. With a history of substance abuse; 5. Women who are pregnant or breast feeding; 6. With organic disease conditions, such as infection, hypertension, diabetes, tumors, autoimmune diseases and so on, or the presence of abnormal liver and kidney functions; 7. Had taken antibiotics, anti-inflammatory drugs, lipid-regulating drugs, psychoneurotic drugs or probiotic products within one month before entering the study; 8. Comorbidity with other psychiatric disorders or mental retardation; 9. Hypersensitivity or allergy to any ingredients in the probiotic/placebo product; 10. Once participants were identified as meeting the criteria of mania/hypomania during the experiment, they would be excluded and given treatment as deemed clinically appropriate.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HAMD-17 scores;HAMA-14 scores; | — |
Secondary
| Measure | Time frame |
|---|---|
| body weight;Fasting blood glucose;triglyceride;high-density lipoprotein;low-density lipoprotein;total cholesterol;Sequencing the gut microbiota; | — |
Countries
China
Contacts
Public ContactZhaoxia Liu
The Second Affiliated Hospital of Nanchang University
Outcome results
None listed