Probiotics Laboratory, Advanced Enzyme Technologies Ltd., Sun Magnetica, Louiswadi, Thane (W), Maharashtra, India.
Medicine (Baltimore). 2021 Jan 22;100(3):e23641. doi: 10.1097/MD.0000000000023641.
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.
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.
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.
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.
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.
通过前瞻性、干预性、随机、双盲、安慰剂对照、符合 CONSORT 标准的临床试验，评估凝结芽孢杆菌 LBSC[DSM17654]在肠易激综合征（IBS）中的安全性和疗效。
细菌疗法对缓解 IBS 和相关功能性胃肠疾病的临床状况显示出有希望的影响。B 型凝结芽孢杆菌 LBSC 是一种经过基因和表型安全测试的益生菌菌株，用于本研究，以研究其对改善 IBS 症状和提高生活质量的影响。
在这项干预性、随机、双盲、安慰剂对照的临床研究中，通过罗马 IV 标准筛选了总共 40 名（18-65 岁）受试者，并将其随机分为干预组和安慰剂组（n=20/组）。两组均接受相同剂量的治疗，即安慰剂（载体）和干预组（B 型凝结芽孢杆菌 LBSC，60 亿/天），为期 80 天。根据方案完成研究的受试者（n=38），并对结果进行了评估，以评估主要和次要终点。
通过消化症状频率问卷 5 分李克特量表评估，与安慰剂组相比，干预组在腹胀/痉挛、腹痛、腹泻、便秘、肠鸣、恶心、呕吐、头痛和焦虑等症状方面有显著改善。根据 IBS 严重程度评分系统和布里斯托粪便形态量表，干预组中最多的“无症状”病例和轻度至中度胃肠道症状以及改善的粪便一致性。胃肠内窥镜检查显示两组胃肠道黏膜无临床差异。B 型凝结芽孢杆菌 LBSC 耐受性良好，无严重不良事件。
B 型凝结芽孢杆菌 LBSC 可安全用于人体，并有效缓解 IBS 的整体病理生理症状，从而提高综合生活质量。
