Role of Bacillus coagulans (Heyndrickxia coagulans)BCP92 in managing irritable bowel syndrome: A randomized, double-blind, multicenter, placebo-controlled clinical trial

Abstract

Background: Irritable bowel syndrome (IBS) is a major global healthcare burden that requires effective and well-tolerated intervention. This study aimed to investigate the effectiveness and safety of Bacillus coagulans BCP92, a probiotic, in managing IBS symptoms. Methods: This randomized controlled trial included 100 participants who strictly adhered to the protocol. Various parameters such as IBS severity, digestive symptom frequency, gastrointestinal symptom frequency, stool consistency, interleukin-6 levels, stress relief, and anxiety levels were evaluated over 12 weeks. Results: B. coagulans BCP92 significantly improved IBS severity (P < .001), and gastrointestinal symptom frequency (P < .001) compared with that in the control group. The stool consistency significantly improved (P < .001). Mental stress relief was remarkable (P = .001), differentiating the test and control groups. No significant change in interleukin-6 levels was observed; however, the safety assessment revealed an excellent profile with no reported severe adverse events. Conclusion: B. coagulans BCP92 is one of the most promising therapeutic options for the management of IBS because it has shown significant efficacy in alleviating symptoms among patients suffering from this condition, resulting in improved stool consistency changes in addition to improving overall mental well-being for its users, thereby foreseeing the elimination of any potential side effects experienced during the implementation of this approach strategy within our health care system, thereby improving patient outcomes and leading to individualization of treatment plans among all individuals diagnosed with this disease entity who may have symptoms, including abdominal pain or discomfort associated with changes in bowel habits.