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凝结芽孢杆菌(海氏肠球菌)BCP92 治疗肠易激综合征的作用:一项随机、双盲、多中心、安慰剂对照临床试验。

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

机构信息

Pellucid Lifesciences Pvt Ltd, Gandhinagar, Gujarat, India.

Gastrocare, Liver & Digestive Disease Center, Bhopal, India.

出版信息

Medicine (Baltimore). 2024 Aug 2;103(31):e39134. doi: 10.1097/MD.0000000000039134.

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.

摘要

背景

肠易激综合征(IBS)是全球范围内的主要医疗保健负担,需要有效的、耐受良好的干预措施。本研究旨在探讨凝结芽孢杆菌 BCP92(一种益生菌)治疗 IBS 症状的有效性和安全性。

方法

本随机对照试验纳入了 100 名严格遵循方案的参与者。在 12 周内评估了 IBS 严重程度、消化症状频率、胃肠道症状频率、粪便稠度、白细胞介素-6 水平、压力缓解和焦虑水平等各种参数。

结果

与对照组相比,凝结芽孢杆菌 BCP92 显著改善了 IBS 严重程度(P<0.001)和胃肠道症状频率(P<0.001)。粪便稠度明显改善(P<0.001)。心理压力缓解显著(P=0.001),区分了试验组和对照组。白细胞介素-6 水平没有显著变化;然而,安全性评估显示出极好的概况,没有报告严重不良事件。

结论

凝结芽孢杆菌 BCP92 是治疗 IBS 的最有前途的治疗选择之一,因为它在缓解患者症状方面表现出显著的疗效,除了改善整体心理健康外,还导致粪便稠度的变化,从而可以预见在我们的医疗保健系统中实施这种方法策略时不会出现任何潜在的副作用,从而改善患者的结局,并导致所有诊断为该疾病实体的个体的治疗计划个体化,这些个体可能有症状,包括与肠道习惯改变相关的腹痛或不适。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a717/11296456/5047f3ace2f5/medi-103-e39134-g001.jpg

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