Efficacy of Bacillus coagulans Unique IS2 in treatment of irritable bowel syndrome in children: a double blind, randomised placebo controlled study

Abstract

The efficacy of the probiotic strain, Bacillus coagulans Unique IS2 in the treatment of Irritable Bowel Syndrome (IBS) was evaluated in children. A total of 141 children of either sex in the age group 4-12 years, diagnosed with IBS according to the Rome III criteria, participated in the double-blind randomised controlled trial. Children received either B. coagulans Unique IS2 chewable tablets or placebo once daily for eight weeks followed by a two week follow-up period. Reduction in pain intensity as well as other symptoms associated with Irritable Bowel Syndrome like abdominal discomfort, bloating, distension, sense of incomplete evacuation, straining at stool, urgency of bowel movement, passage of gas and mucus, and bowel habit satisfaction were assessed. B. coagulans Unique IS2 treated group showed a greater reduction in pain scores as evaluated by a weekly pain intensity scale. There was a significant reduction (P<0.0001) in pain intensity in the probiotic treated group (7.6±0.98) as compared to the placebo group (4.2±1.41) by the end of the treatment period (8 weeks). There was also a significant improvement in stool consistency as well as reduction in abdominal discomfort, bloating, staining, urgency, incomplete evacuation and passage of gas. Bowel habit satisfaction and global assessment of relief was also observed in the B. coagulans Unique IS2 treated group as compared to the placebo group. This study demonstrates the efficacy of B. coagulans Unique IS2 in reducing the symptoms of Irritable Bowel Syndrome in children in the age group of 4-12 years.

Randomized clinical trial: the effect of probiotic Bacillus coagulans Unique IS2 vs. placebo on the symptoms management of irritable bowel syndrome in adults

“…Bacillus coagulans Unique IS2 TM (MTCC 5260, ATCC PTA-11748) is a spore forming, non-toxic commercial probiotic strain 23,24 . The clinical trials conducted on anti-hypercholesterolemic effect 25 , liver cirrhosis 26 , bacterial vaginosis 27 , acute-diarrhea 28 , abdominal pain 29 , constipation 30 , oral health 31 and IBS in children 22 have proven therapeutic efficacy and safety of this strain. Moreover, in vitro studies on anti-inflammatory and immune-modulatory activity 32 , anti-proliferative effects in colon cancer cells 33 , and in vivo anti-inflammatory effects in animal model 34 strengthen the therapeutic applicability.…”

“…The safety of probiotic B . coagulans Unique IS2 has been already established and reported 22,24–33 . In this study, no severe adverse events and deaths with probiotic treatment were detected, which suggested safety of B .…”

“…In our previous study, we have shown that B . coagulans Unique IS2 supplementation reduced abdominal pain, discomfort and disease severity and improved the stool consistency in children (4–12 years) with IBS 22 . In the present double blind, randomised controlled study, we investigated the effect of B .…”

Efficacy of UB0316, a multi-strain probiotic formulation in patients with type 2 diabetes mellitus: A double blind, randomized, placebo controlled study

“…salivarius UBLS22) [16], complications of liver cirrhosis ( B . coagulans Unique IS2) [17], irritable bowel syndrome in childrens [18] and adults ( B . coagulans Unique IS2) [19], childhood abdominal pain ( B .…”

Isolation of food-derived bacteria inducing interleukin-22 in B cells

“…B. coagulans is a sporeforming bacterium that produces lactic acid. B. coagulans spores are probiotics and have beneficial effects in humans, such as amelioration of irritable bowel syndrome [12,13], bacterial vaginosis [14], and intestinal disorders [15][16][17], and absorption of amino acids from proteins [18,19]. In addition, their use in broilers and fish yields growth-promoting and disease-preventing effects [20,21].…”