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Bacillus coagulans MTCC 5856 supplementation in the management of diarrhea predominant Irritable Bowel Syndrome: a double blind randomized placebo controlled pilot clinical study.
Nutr J 2016; 15:21NJ

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.

Authors+Show Affiliations

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

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26922379

Citation

Majeed, Muhammed, et al. "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, vol. 15, 2016, p. 21.
Majeed M, Nagabhushanam K, Natarajan S, et al. Bacillus coagulans MTCC 5856 supplementation in the management of diarrhea predominant Irritable Bowel Syndrome: a double blind randomized placebo controlled pilot clinical study. Nutr J. 2016;15:21.
Majeed, M., Nagabhushanam, K., Natarajan, S., Sivakumar, A., Ali, F., Pande, A., ... Karri, S. K. (2016). 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, 15, p. 21. doi:10.1186/s12937-016-0140-6.
Majeed M, et al. Bacillus Coagulans MTCC 5856 Supplementation in the Management of Diarrhea Predominant Irritable Bowel Syndrome: a Double Blind Randomized Placebo Controlled Pilot Clinical Study. Nutr J. 2016 Feb 27;15:21. PubMed PMID: 26922379.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Bacillus coagulans MTCC 5856 supplementation in the management of diarrhea predominant Irritable Bowel Syndrome: a double blind randomized placebo controlled pilot clinical study. AU - Majeed,Muhammed, AU - Nagabhushanam,Kalyanam, AU - Natarajan,Sankaran, AU - Sivakumar,Arumugam, AU - Ali,Furqan, AU - Pande,Anurag, AU - Majeed,Shaheen, AU - Karri,Suresh Kumar, Y1 - 2016/02/27/ PY - 2015/11/18/received PY - 2016/02/20/accepted PY - 2016/2/29/entrez PY - 2016/2/29/pubmed PY - 2016/10/21/medline SP - 21 EP - 21 JF - Nutrition journal JO - Nutr J VL - 15 N2 - 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. SN - 1475-2891 UR - https://www.unboundmedicine.com/medline/citation/26922379/Bacillus_coagulans_MTCC_5856_supplementation_in_the_management_of_diarrhea_predominant_Irritable_Bowel_Syndrome:_a_double_blind_randomized_placebo_controlled_pilot_clinical_study_ L2 - https://nutritionj.biomedcentral.com/articles/10.1186/s12937-016-0140-6 DB - PRIME DP - Unbound Medicine ER -