title: Bacillus coagulans MTCC 5856 supplementation in the management of diarrhea predominant Irritable Bowel Syndrome: a double blind randomized placebo controlled pilot clinical study.
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.affiliation: Sami Labs Limited, Peenya Industrial Area, Bangalore, 560 058, Karnataka, India.|Sabinsa Corporation, 20 Lake Drive, East Windsor, NJ, 08520, USA.
authors.forename: Muhammed
authors.initials: M
authors.lastname: Majeed
authors.affiliation: Sabinsa Corporation, 20 Lake Drive, East Windsor, NJ, 08520, USA.
authors.forename: Kalyanam
authors.initials: K
authors.lastname: Nagabhushanam
authors.affiliation: Sami Labs Limited, Peenya Industrial Area, Bangalore, 560 058, Karnataka, India.
authors.forename: Sankaran
authors.initials: S
authors.lastname: Natarajan
authors.affiliation: Sami Labs Limited, Peenya Industrial Area, Bangalore, 560 058, Karnataka, India.
authors.forename: Arumugam
authors.initials: A
authors.lastname: Sivakumar
authors.affiliation: Sami Labs Limited, Peenya Industrial Area, Bangalore, 560 058, Karnataka, India.
authors.forename: Furqan
authors.initials: F
authors.lastname: Ali
authors.affiliation: Sabinsa Corporation, 20 Lake Drive, East Windsor, NJ, 08520, USA.
authors.forename: Anurag
authors.initials: A
authors.lastname: Pande
authors.affiliation: Sabinsa Corporation, 750 Innovation Circle, Payson, UT, 84651, USA.
authors.forename: Shaheen
authors.initials: S
authors.lastname: Majeed
authors.affiliation: ClinWorld Private Limited, # 19/1 & 19/2, I Main, II Phase, Peenya Industrial Area, Bangalore, 560 058, Karnataka, India. suresh@clinworld.org.
authors.forename: Suresh Kumar
authors.initials: SK
authors.lastname: Karri
mesh_terms: D015746:Abdominal Pain / Q000628:therapy; D000293:Adolescent; D000328:Adult; D001407:Bacillus; D003967:Diarrhea / Q000628:therapy*; D019468:Disease Management; D004311:Double-Blind Method; D005260:Female; D000069196:Gastrointestinal Microbiome; D041981:Gastrointestinal Tract / Q000378:metabolism / Q000382:microbiology; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D010865:Pilot Projects; D019936:Probiotics / Q000008:administration & dosage*; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D055815:Young Adult