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

Muhammed Majeed, Kalyanam Nagabhushanam, Sankaran Natarajan, Arumugam Sivakumar, Furqan Ali, Anurag Pande, Shaheen Majeed, Suresh Kumar Karri, Muhammed Majeed, Kalyanam Nagabhushanam, Sankaran Natarajan, Arumugam Sivakumar, Furqan Ali, Anurag Pande, Shaheen Majeed, Suresh Kumar Karri

Abstract

Background: Bacillus 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.

Methods: Thirty 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 × 10(9) 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.

Results: Laboratory 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.

Conclusions: The study concluded that the B. coagulans MTCC 5856 at a dose of 2 × 10(9) 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.

Figures

Fig. 1
Fig. 1
Flow chart of study procedures. Legend: From eligible thirty six subjects who were fit into the inclusion and exclusion criteria, 31 completed the study. At every follow up visit, study evaluations and assessments were made in both the study groups
Fig. 2
Fig. 2
a Visual analog scale for abdominal pain. Legend: A value of ‘0’ indicates ‘no pain’ while ‘10’ indicates ‘worst possible pain’. *p < 0.01 between placebo and active groups on visit 3 and 4. b GI discomfort assessment for IBS symptoms. Legend: Low value indicates less GI discomfortness. *p < 0.01 between placebo and active groups from visits 2 to 4. c Bristol stool score for stool frequency. Legend: High value indicates diarrhea where the stool is ‘watery, with no solid pieces. *p < 0.01 between placebo and active groups from visits 2 to 4. d Physician’s global assessment for disease severity. Legend: Scale ranges from 0 to 10, where 0 indicates ‘very poor’ and 10 indicates ‘excellent’. *p < 0.01 between placebo and active groups on visits 3 and 4. e IBS –QOL. Legend: High QOL value indicates poor quality of life. *p < 0.01 between placebo and active groups on visits 3 and 4. All the values are expressed as mean ± S.E

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