Clinical evaluation of the antidepressant effect of the use of probiotics in bipolar disorder

INTERVENTION: G07.203.300.456.500 Interventions The 84 participants will be randomized to two arms, namely: Placebo group (42 participants) and probiotic group (42 participants). Placebo Group (GPL42): in addition to the usual drug treatment, participants will receive placebo supplementation, once a day. As adopted by Messaoudi et al., 2011 and Dickerson et al., 2018, the placebo will contain pharmaceutical excipients maltodextrin and cellulose in an amount equivalent to 1.5g that should be handled in capsules, in a pharmacy, with no active ingredient, containing only the pharmaceutical adjunct. Probiotic group (GPR42): in addition to the usual drug treatment, they will receive probiotic supplementation. We will adopt the same bacterial strains proposed by Messaoudi et al. 2011 and Dickerson et al. 2018 in an exclusive formulation containing the combination of the strains Lactobacillus helveticus and Bifidobacterium longum (Messaoudi et al., 2011) and Lactobacillus GG and Bifidobacterium lactis (Dickerson et al., 2018) containing 1 billion CFU of each strain, respectively, in capsules resulting, therefore, formulations with 4 billion UFC handled at the Pharmacy Mortar, Perdizes Unit, São Paulo, SP. For all groups, the design of the clinical trial will last for 12 weeks. The scales will be applied every two as proposed in the ISBD (International Society for Bipolar Disorder) guidelines (Tohen, 2009). We will carry out the monitored study for a period of 12 weeks (3 months). In the preliminary assessment (baseline), the patients recruited for the study will receive the necessary guidance on the research and will receive a sufficient amount of probiotic or placebo to consume 1 time / day at each moment. Those involved will be duly advised to ingest a capsule always with CONDITION: Bipolar disorders PRIMARY OUTCOME: Assess the effect of probiotic supplementation on symptom improvement; depression in TB patients using the Montegomery‐Asberg depression scale. A 50% reduction in depressive symptoms is expected. SECONDARY OUTCOME: Assess whether possible improvements in depression would be mediated through ; intestinal inflammation biomarkers (MPO, AAT, NEO, LPS, Zonulin and ; FABP2) and through serum inflammatory biomarkers (IL‐1ß, IL‐4, IL‐6, ; IL‐10, TNF‐a, IFN‐?). To check if the improvement in depression is mediated by these biomarkers, a collection will be performed in the sixth week of the study. INCLUSION CRITERIA: Bipolar disorder type I or type II. Score on the YOUNG scale less than 8. Score on the MADRS scale greater than 8.