标题：Bacillus coagulans MTCC 5856 for the management of major depression with irritable bowel syndrome: a randomised, double-blind, placebo controlled, multi-centre, pilot clinical study
摘要：BackgroundThe modification of microbial ecology in human gut by supplementing probiotics may be an alternative strategy to ameliorate or prevent depression.ObjectiveThe current study was conducted to assess the safety and efficacy of the probiotic strainBacillus coagulansMTCC 5856 for major depressive disorder (MDD) in IBS patients.MethodPatients (n= 40) diagnosed for MDD with IBS were randomized (1:1) to receive placebo orB. coagulansMTCC 5856 at a daily dose of 2 × 109 cfu (2 billion spores) and were maintained to the end of double-blind treatment (90 days). Changes from baseline in clinical symptoms of MDD and IBS were evaluated through questionnaires.ResultsSignificant change (p= 0.01) in favour of theB. coagulansMTCC 5856 was observed for the primary efficacy measure Hamilton Rating Scale for Depression (HAM-D), Montgomery-Asberg Depression Rating Scale (MADRS), Center for Epidemiological Studies Depression Scale (CES-D) and Irritable bowel syndrome quality of life questionnaire (IBS-QOL). Secondary efficacy measures i.e. Clinical Global Impression-Improvement rating Scale (CGI-I), Clinical Global Impression Severity rating Scale (CGI-S), Gastrointestinal Discomfort Questionnaire (GI-DQ) and Modified Epworth Sleepiness Scale (mESS) also showed significant results (p= 0.01) inB. coagulansMTCC 5856 group compared to placebo group except dementia total reaction scoring. Serum myeloperoxidase, an inflammatory biomarker was also significantly reduced (pConclusionB. coagulansMTCC 5856 showed robust efficacy for the treatment of patients experiencing IBS symptoms with major depressive disorder. The improvement in depression and IBS symptoms was statistically significant and clinically meaningful. These findings supportB. coagulansMTCC 5856 as an important new treatment option for major depressive disorder in IBS patients.
