Bacillus coagulans MTCC 5856 supplementation in the management of diarrhea predominant Irritable Bowel Syndrome: a double blind randomized placebo controlled pilot clinical study

Nutrition Journal

Research

Suresh Kumar Karri¹  Kalyanam Nagabhushanam²  Anurag Pande²  Shaheen Majeed³  Furqan Ali⁴  Sankaran Natarajan⁴  Arumugam Sivakumar⁴  Muhammed Majeed⁵ 

[1] ClinWorld Private Limited, # 19/1 & 19/2, I Main, II Phase, Peenya Industrial Area, 560 058, Bangalore, Karnataka, India;Sabinsa Corporation, 20 Lake Drive, 08520, East Windsor, NJ, USA;Sabinsa Corporation, 750 Innovation Circle, 84651, Payson, UT, USA;Sami Labs Limited, Peenya Industrial Area, 560 058, Bangalore, Karnataka, India;Sami Labs Limited, Peenya Industrial Area, 560 058, Bangalore, Karnataka, India;Sabinsa Corporation, 20 Lake Drive, 08520, East Windsor, NJ, USA;

关键词: Lactobacillus;    Bacillus coagulans;    LactoSpore®;    Diarrhea;    Irritable Bowel Syndrome;   

DOI  :  10.1186/s12937-016-0140-6

 received in 2015-11-18, accepted in 2016-02-20,  发布年份 2016

来源: Springer

【 摘 要 】

BackgroundBacillus coagulans MTCC 5856 has been marketed as a dietary ingredient, but its efficacy in diarrhea predominant irritable bowel syndrome (IBS) condition has not been clinically elucidated till date. Thus, a double blind placebo controlled multi-centered trial was planned to evaluate the safety and efficacy of B. coagulans MTCC 5856 in diarrhea predominant IBS patients.MethodsThirty six newly diagnosed diarrhea predominant IBS patients were enrolled in three clinical centres. Along with standard care of treatment, 18 patients in group one received placebo while in group two 18 patients received B. coagulans MTCC 5856 tablet containing 2 × 109 cfu/day as active for 90 days. Clinical symptoms of IBS were considered as primary end point measures and were evaluated through questionnaires. The visual analog scale (VAS) was used for abdominal pain. Physician’s global assessment and IBS quality of life were considered as secondary efficacy measures and were monitored through questionnaires.ResultsLaboratory parameters, anthropometric and vital signs were within the normal clinical range during the 90 days of supplementation in placebo and B. coagulans MTCC 5856 group. There was a significant decrease in the clinical symptoms like bloating, vomiting, diarrhea, abdominal pain and stool frequency in a patient group receiving B. coagulans MTCC 5856 when compared to placebo group (p < 0.01). Similarly, disease severity also decreased and the quality of life increased in the patient group receiving B. coagulans MTCC 5856 when compared to placebo group.ConclusionsThe study concluded that the B. coagulans MTCC 5856 at a dose of 2 × 109 cfu/day along with standard care of treatment was found to be safe and effective in diarrhea predominant IBS patients for 90 days of supplementation. Hence, B. coagulans MTCC 5856 could be a potential agent in the management of diarrhea predominant IBS patients.

【 授权许可】

CC BY   
© Majeed et al. 2016