Clinical Development & Science Communications, Vedic Lifesciences Pvt Ltd, Mumbai, India.
Medical Department, ADM Health & Wellness, London, UK.
Gut Microbes. 2024 Jan-Dec;16(1):2338322. doi: 10.1080/19490976.2024.2338322. Epub 2024 Apr 17.
To determine the efficacy of the probiotic CECT 7347 (ES1) and postbiotic heat-treated CECT 7347 (HT-ES1) in improving symptom severity in adults with diarrhea-predominant irritable bowel syndrome (IBS-D), a randomised, double-blind, placebo-controlled trial with 200 participants split into three groups was carried out. Two capsules of either ES1, HT-ES1 or placebo were administered orally, once daily, for 84 days (12 weeks). The primary outcome was change in total IBS-Symptom Severity Scale (IBS-SSS) score from baseline, compared to placebo. Secondary outcome measures were stool consistency, quality of life, abdominal pain severity and anxiety scores. Safety parameters and adverse events were also monitored. The change in IBS-SSS scores from baseline compared to placebo, reached significance in the ES1 and HT-ES1 group, on Days 28, 56 and 84. The decrease in mean IBS-SSS score from baseline to Day 84 was: ES1 (-173.70 [±75.60]) vs placebo (-60.44 [±65.5]) ( < .0001) and HT-ES1 (-177.60 [±79.32]) vs placebo (-60.44 [±65.5]) ( < .0001). Secondary outcomes included changes in IBS-QoL, APS-NRS, stool consistency and STAI-S and STAI-T scores, with changes from baseline to Day 84 being significant in ES1 and HT-ES1 groups, compared to the placebo group. Both ES1 and HT-ES1 were effective in reducing IBS-D symptom severity, as evaluated by measures such as IBS-SSS, IBS-QoL, APS-NRS, stool consistency, and STAI, in comparison to the placebo. These results are both statistically significant and clinically meaningful, representing, to the best of the authors' knowledge, the first positive results observed for either a probiotic or postbiotic from the same strain, in this particular population.
为了确定益生菌 CECT7347(ES1)和后生元热处理的 CECT7347(HT-ES1)在改善以腹泻为主的肠易激综合征(IBS-D)成人患者症状严重程度方面的疗效,进行了一项随机、双盲、安慰剂对照试验,共纳入 200 名参与者,分为三组。ES1、HT-ES1 或安慰剂每天口服 2 粒,持续 84 天(12 周)。主要终点是与安慰剂相比,从基线开始的总 IBS 症状严重程度量表(IBS-SSS)评分的变化。次要终点测量指标包括粪便稠度、生活质量、腹痛严重程度和焦虑评分。还监测了安全性参数和不良事件。与安慰剂相比,ES1 和 HT-ES1 组在第 28、56 和 84 天,IBS-SSS 评分的变化达到了显著水平。从基线到第 84 天,IBS-SSS 评分的平均下降值分别为:ES1(-173.70 [±75.60])与安慰剂(-60.44 [±65.5])( < .0001)和 HT-ES1(-177.60 [±79.32])与安慰剂(-60.44 [±65.5])( < .0001)。次要结局包括 IBS-QoL、APS-NRS、粪便稠度和 STAI-S 和 STAI-T 评分的变化,与安慰剂组相比,ES1 和 HT-ES1 组在第 84 天的变化均有显著意义。ES1 和 HT-ES1 均能有效减轻 IBS-D 症状严重程度,通过 IBS-SSS、IBS-QoL、APS-NRS、粪便稠度和 STAI 等指标评估,与安慰剂相比,差异有统计学意义且具有临床意义。这些结果在统计学上和临床上均有意义,据作者所知,这是同一菌株的益生菌或后生元在该特定人群中首次观察到的阳性结果。
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