Sami-Sabinsa Group Limited, Karnataka, India.
Sabinsa Corporation, NJ.
Medicine (Baltimore). 2023 Mar 3;102(9):e33109. doi: 10.1097/MD.0000000000033109.
Gut microbiome dysbiosis is a major cause of abdominal gas, bloating, and distension. Bacillus coagulans MTCC 5856 (LactoSpore) is a spore-forming, thermostable, lactic acid-producing probiotic that has numerous health benefits. We evaluated the effect of Lacto Spore on improving the clinical symptoms of functional gas and bloating in healthy adults.
Multicenter, randomized, double-blind, placebo-controlled study at hospitals in southern India. Seventy adults with functional gas and bloating with a gastrointestinal symptom rating scale (GSRS) indigestion score ≥ 5 were randomized to receive B coagulans MTCC 5856 (2 billion spores/day, N = 35) or placebo (N = 35) for 4 weeks. Changes in the GSRS-Indigestion subscale score for gas and bloating and global evaluation of patient's scores from screening to the final visit were the primary outcomes. The secondary outcomes were Bristol stool analysis, brain fog questionnaire, changes in other GSRS subscales, and safety.
Two participants from each group withdrew from the study and 66 participants (n = 33 in each group) completed the study. The GSRS indigestion scores changed significantly (P < .001) in the probiotic group (8.91-3.06; P < .001) compared to the placebo (9.42-8.43; P = .11). The median global evaluation of patient's scores was significantly better (P < .001) in the probiotic group (3.0-9.0) than in the placebo group (3.0-4.0) at the end of the study. The cumulative GSRS score, excluding the indigestion subscale, decreased from 27.82 to 4.42% (P < .001) in the probiotic group and 29.12 to 19.33% (P < .001) in the placebo group. The Bristol stool type improved to normal in both the groups. No adverse events or significant changes were observed in clinical parameters throughout the trial period.
Bacillus coagulans MTCC 5856 may be a potential supplement to reduce gastrointestinal symptoms in adults with abdominal gas and distension.
肠道微生物群落失调是腹部气体、腹胀和膨胀的主要原因。凝结芽孢杆菌 MTCC5856（LactoSpore）是一种形成孢子、耐热、产乳酸的益生菌，具有许多健康益处。我们评估了 LactoSpore 对改善健康成年人功能性气体和腹胀的临床症状的影响。
在印度南部的医院进行的多中心、随机、双盲、安慰剂对照研究。70 名功能性气体和腹胀伴有胃肠道症状评分量表（GSRS）消化不良评分≥5 的成年人被随机分为两组，分别接受凝结芽孢杆菌 MTCC5856（每天 20 亿个孢子，N=35）或安慰剂（N=35）治疗 4 周。主要结局是 GSRS-消化不良亚量表评分中气体和腹胀的变化以及从筛查到最后一次就诊的患者总体评估评分。次要结局是布里斯托粪便分析、脑雾问卷、其他 GSRS 亚量表的变化以及安全性。
每组各有 2 名参与者退出研究，共有 66 名参与者（每组 33 名）完成了研究。益生菌组的 GSRS 消化不良评分有显著变化（P<.001）（8.91-3.06；P<.001），而安慰剂组无显著变化（9.42-8.43；P=.11）。益生菌组的患者总体评估评分中位数明显更好（P<.001）（3.0-9.0），而安慰剂组为（3.0-4.0）。研究结束时，排除消化不良亚量表后的累积 GSRS 评分从益生菌组的 27.82%降至 4.42%（P<.001），从安慰剂组的 29.12%降至 19.33%（P<.001）。两组的布里斯托粪便类型均改善为正常。整个试验期间，临床参数无不良反应或显著变化。
凝结芽孢杆菌 MTCC5856 可能是一种潜在的补充剂，可以减少有腹部气体和膨胀的成年人的胃肠道症状。
