Efficacy and safety of Bacillus coagulans LBSC in irritable bowel syndrome

Abstract

Goals: To evaluate safety and efficacy of Bacillus coagulans LBSC [DSM17654] in irritable bowel syndrome (IBS) through a prospective, interventional, randomized, double-blind, and placebo-controlled, CONSORT compliant clinical trial. Background: Bacteriotherapy shows promising impact on alleviating clinical conditions of IBS and associated functional gastrointestinal disorders. B coagulans LBSC is a genetically and phenotypically safe probiotic strain used in this study to study its impact on ameliorating IBS symptoms and improving quality of life. Methods: In this interventional, randomized, double-blind, placebo-controlled clinical study, total 40 subjects (18–65 years) were screened through Rome IV criteria and randomized into 2 groups, that is, interventional and placebo arm (n = 20/arm). Similar dosages were received by both the arm, that is, placebo (vehicle) and interventional arm (B coagulans LBSC, 6 billion/d) for a period of 80 days. Study completed with per protocol subjects (n = 38) and results were considered to evaluate the primary and secondary endpoints. Results: Assessment through Digestive Symptom Frequency Questionnaire 5 point Likert scale showed significant improvement in interventional arm compared to placebo on symptoms such as bloating/cramping, abdominal pain, diarrhea, constipation, stomach rumbling, nausea, vomiting, headache, and anxiety. Maximum of “no symptoms” cases and mild to moderate gastrointestinal symptoms along with improved stool consistency were from interventional arm tested following IBS severity scoring system and Bristol stool form scale. Upper gastrointestinal endoscopy revealed no clinical difference of gastrointestinal mucosa between both the arms. B coagulans LBSC was well tolerated with no serious adverse events. Conclusions: B coagulans LBSC was safe for human consumption and efficacious in alleviating overall pathophysiological symptoms of IBS and thereby improving inclusive quality of life evaluated.

The Effect of Probiotics on Quality of Life, Depression and Anxiety in Patients with Irritable Bowel Syndrome: A Systematic Review and Meta-Analysis

“…The studies were published between 2005 and 2021. Most studies were conducted in Europe (n = 19; 54%) [22][23][24][25][26][27][28][29][30][31][32][33][34][35][36][37][38][39][40], followed by Asia (n = 11; 31%) [41][42][43][44][45][46][47][48][49][50][51], America (n = 4; 11%) [52][53][54][55] and Africa (n = 1; 3%) [56]. In total, the 35 trials included 4717 participants.…”

“…In total, the 35 trials included 4717 participants. The median age was 42 [41][42][43][44][45][46] years and 68% of the participants were women. The duration of the interventions ranged between 4 and 24 weeks with a median length of 7 [5.5-8] weeks.…”

Probiotics, Prebiotics, and Synbiotics in the Irritable Bowel Syndrome Treatment: A Review

“…Most of the above-described studies are focused on all IBS subtypes [ 80 , 81 , 82 , 87 , 88 , 89 , 95 , 100 , 108 , 109 , 112 , 113 , 115 , 116 , 118 , 119 , 120 ]. Although, several studies did not differentiate the form of the disease among participants [ 79 , 83 , 84 , 85 , 90 , 91 , 92 , 96 , 101 , 103 , 104 , 127 ]. Moreover, Oh et al (2019) performed the analysis of probiotic impact on IBS patients with the exclusion of subjects suffering from IBS-C [ 124 ].…”

“…This probiotic improved symptoms of IBS only among individuals suffering from the IBS-D subtype[100]. Other effective probiotics in improving IBS symptoms are strains of Bacillus coagulans[101][102][103][104] Majeed et al (2018). observed that B. coagulans MTCC 5856 could reduce sleeplessness and depression in IBS-D patients[102].Gupta et al (2012) noted the beneficial impact of B. coagulans LBSC on GIT microbiota of IBS individuals[104].…”

“…Other effective probiotics in improving IBS symptoms are strains of Bacillus coagulans[101][102][103][104] Majeed et al (2018). observed that B. coagulans MTCC 5856 could reduce sleeplessness and depression in IBS-D patients[102].Gupta et al (2012) noted the beneficial impact of B. coagulans LBSC on GIT microbiota of IBS individuals[104]. Likewise,Sun et al (2018) used Clostridium butyricum as IBS treatment in the trial, in which probiotic exhibited the ability to ameliorate symptoms of the disease.…”