Bipolar disorders
Conditions
Interventions
The 84 participants will be randomized to two arms, namely: placebo group (42 participants) and probiotic group (42 participants). The placebo group (GPL42) will receive, in addition to the usual drug
G07.203.300.456.500
Sponsors
Universidade de São Paulo
Universidade de São Paulo
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Bipolar disorder type I or type II; score on the YMRS scale less than 8; score on the MADRS scale greater than 8
Exclusion criteria
Exclusion criteria: Pregnant or lactating women; patients dependent on alcohol and illicit drugs like marijuana, crack or cocaine; patients on prolonged antibiotic therapy; immunosuppressive therapies; introduction of recent antidepressants up to 15 days from the beginning of the study; HIV carriers with manifestations of the syndrome of acquired immunodeficiency and serious clinical diseases; with delayed mental or inability to understand the study instructions will be excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of probiotic supplementation on the improvement of depressive symptoms in patients with bipolar disorder using the Montegomery-Asberg depression scale every two weeks of intervention for twelve weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess whether possible improvements in depression would be mediated by intestinal inflammation biomarkers (LPS, Zonulin and FABP2) and by serum inflammatory biomarkers (IL-1ß, IL-4, IL-6, IL-10, TNF-a, IFN-?) collected in the sixth week of the study. | — |
Countries
Brazil
Contacts
Public ContactAdiel Rios
Universidade de São Paulo
Outcome results
None listed