The Effect of Probiotics in Treatment of Bipolar Disorder.

Phase 3

• Conditions: Type 1 bipolar disorder.; Bipolar disorder

• Registration Number: IRCT20180819040836N1
• Lead Sponsor: Kerman University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 5 November 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Detection of type 1 bipolar disorder based on DSM5.
Age 18 to 65 years old.
No change in dosage of antipsychotics, lithium and sodium valproate in the 2 weeks prior to entering the study and during treatment.

Exclusion Criteria

Pregnancy and Lactation.
Hypersensivity to lactose.
Chronic diseases (heart, kidney, lung and liver).
Use of supplements and probiotics in the last 2 months.
Schizophrenia and other psychotic disorders.
seizure.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determination of serum IL-6 concentration. Timepoint: Measurement of serum IL-6 concentration at baseline,1month and 2 months later. Method of measurement: A kit for measuring serum levels of IL-6.;Determination of serum IL-10 concentration. Timepoint: Measurement of serum IL-10 concentration at baseline, 1 month and 2 months later. Method of measurement: A kit for measuring serum levels of IL-10.;Determination of serum TNF-a concentration. Timepoint: Measurement of serum TNF-a concentration at baseline, 1 month and 2 months later. Method of measurement: A kit for measuring serum levels of TNF-a.

Secondary Outcome Measures

Name	Time	Method
Hamilton Scale of Depression Scale. Timepoint: At the start of the study, one month and two months later. Method of measurement: Based on the Hamilton Depression Questionnaire.;Scale Young Mania Scale. Timepoint: At the start of the study, one month and two months later. Method of measurement: Based on Young Mania Questionnaire.;Improvement of Mania Symptoms and Depression. Timepoint: At the start of the study, one month and two months later. Method of measurement: Based on the Clinical Global Impression and Impronement Bipolar Questionnaire.