Research and Applications Department, Gnosis by Lesaffre, Lesaffre Group, Marcq-en-Baroeul 59700, France.
Data Science and Bioinformatics Laboratory, Research and Development Department, Lesaffre International, Lesaffre Group, Marcq-en-Baroeul 59700, France.
World J Gastroenterol. 2022 Jun 14;28(22):2509-2522. doi: 10.3748/wjg.v28.i22.2509.
Probiotics are a promising solution for managing irritable bowel syndrome (IBS). () I-3856 has already demonstrated beneficial effects in IBS subjects, particularly in IBS with predominant constipation (IBS-C).
To confirm the efficacy of I-3856 in the management of gastrointestinal symptoms in IBS-C.
A randomized, double-blind, placebo-controlled clinical study was performed in a total of 456 subjects. After a run-in period, subjects were randomly assigned to the group receiving I-3856 (8 × 10 CFU daily) or the placebo for 8 wk, and they performed daily self-evaluations of gastrointestinal symptoms. The primary objective was to assess the effect of the probiotic on abdominal pain. The secondary objectives were the evaluation of other gastrointestinal symptoms, bowel movement frequency and consistency, and quality of life (QOL).
A significantly higher proportion of abdominal pain responders was reported in the Probiotic group (45.1% 33.9%, = 0.017). A nonsignificant difference in the area under the curve for abdominal pain over the second month of supplementation was observed in subjects receiving probiotic placebo [ = 0.073, 95%CI: -0.59 (-1.23; 0.05)]. No statistically significant differences were reported in the evolution of bowel movement frequency and stool consistency between the groups. After 8 wk of supplementation, the overall QOL score was significantly higher in the Probiotic group than in the Placebo group [ = 0.047, 95%CI: 3.86 (0.52; 7.20)]. Furthermore, exploratory analyses showed statistically significant and clinically relevant improvements in QOL scores in abdominal pain responders nonresponders.
The results of this clinical study confirmed the abdominal pain alleviation properties of I-3856 in IBS-C. Abdominal pain relief was associated with improved QOL. ClinicalTrials.gov identifier: NCT03150212.
益生菌是治疗肠易激综合征（IBS）的一种有前途的方法。（）I-3856 已在 IBS 患者中显示出有益效果，特别是在 IBS 伴主要便秘（IBS-C）中。
确认 I-3856 在 IBS-C 胃肠道症状管理中的疗效。
在总共 456 名受试者中进行了一项随机、双盲、安慰剂对照的临床研究。经过导入期后，受试者被随机分配到接受 I-3856（每日 8×10 CFU）或安慰剂治疗 8 周的组，并进行每日胃肠道症状自我评估。主要目的是评估益生菌对腹痛的影响。次要目标是评估其他胃肠道症状、排便频率和一致性以及生活质量（QOL）。
报告益生菌组腹痛缓解者的比例明显更高（45.1%比 33.9%，=0.017）。接受益生菌和安慰剂的受试者在补充第二个月腹痛的曲线下面积无显著差异[=0.073，95%CI：-0.59（-1.23；0.05）]。两组之间的排便频率和粪便一致性均无统计学差异。补充 8 周后，益生菌组的总体 QOL 评分明显高于安慰剂组[=0.047，95%CI：3.86（0.52；7.20）]。此外，探索性分析显示，在腹痛缓解者和非缓解者中，QOL 评分均有统计学显著和临床相关的改善。
这项临床研究的结果证实了 I-3856 在 IBS-C 中缓解腹痛的特性。腹痛缓解与 QOL 改善相关。临床试验注册号：NCT03150212。
