Clinical Development, Human Health, Chr. Hansen A/S, Hoersholm 2970, Denmark.
Clinical Development, Vedic Lifesciences, Mumbai 400053, India.
World J Gastroenterol. 2023 Jul 28;29(28):4451-4465. doi: 10.3748/wjg.v29.i28.4451.
Probiotics have shown promise in alleviating symptoms of diarrhea-predominant irritable bowel syndrome (IBS-D); however, the certainty of evidence is low. Well-powered randomized controlled dose-ranging trials are warranted on promising single-strain candidates.
To investigate the clinical efficacy of () Lpla33 (DSM34428) in adults with IBS-D.
This is a randomized, double-blind, placebo-controlled, multi-center, and dose-ranging study. Three hundred and seven adults, 18-70 years of age, with IBS-D, according to Rome IV criteria, were allocated (1:1:1) to receive placebo or Lpla33 at 1 × 10 (1B) or 1 × 10 (10B) colony-forming units/d over an 8-wk intervention period. The primary outcome was the change in IBS severity scoring system (IBS-SSS) total score after 8 wk, while secondary and exploratory outcomes included abdominal pain severity, IBS related quality of life, stool and microbial profile, and perceived stress.
IBS-SSS was significantly reduced, after 8 wk, in participants receiving 1B (-128.45 ± 83.30; < 0.001) and 10B (-156.77 ± 99.06; < 0.001), compared to placebo (-58.82 ± 74.75). Further, a dose-ranging effect was observed, with a greater absolute reduction in the 10B group ( < 0.05). A reduction in sub-scores related to abdominal pain, abdominal distension, bowel habits, and quality of life was observed in both groups compared to placebo ( < 0.001). Further, 62.5% and 88.4% of participants administered 1B and 10B, respectively, were classified as stool consistency responders based on a reduction in diarrheal stool form, as compared to 26.3% in the placebo group ( < 0.001). In contrast, no significant shifts were observed in microbial diversity.
Lpla33 (DSM34428) is well tolerated and improves IBS symptom severity with a dose-ranging effect and a corresponding normalization of bowel habits in adults with IBS-D.
益生菌已被证明可缓解腹泻为主的肠易激综合征（IBS-D）的症状；然而，证据的确定性较低。有必要对有前途的单一菌株候选药物进行有力的随机对照剂量范围试验。
研究 （）Lpla33（DSM34428）在 IBS-D 成人中的临床疗效。
这是一项随机、双盲、安慰剂对照、多中心、剂量范围研究。307 名年龄在 18-70 岁之间、符合罗马 IV 标准的 IBS-D 成人患者被随机分配（1:1:1）接受安慰剂或 1×10（1B）或 1×10（10B）菌落形成单位/天的 （）Lpla33 治疗，干预期为 8 周。主要结局是 8 周后 IBS 严重程度评分系统（IBS-SSS）总分的变化，次要和探索性结局包括腹痛严重程度、IBS 相关生活质量、粪便和微生物谱以及感知压力。
与安慰剂组（-58.82±74.75）相比，接受 1B（-128.45±83.30； <0.001）和 10B（-156.77±99.06； <0.001）治疗的患者，8 周后 IBS-SSS 显著降低。此外，还观察到剂量范围效应，10B 组的绝对降低更大（<0.05）。与安慰剂组相比，两组患者的腹痛、腹胀、排便习惯和生活质量相关的亚评分均降低（<0.001）。此外，分别接受 1B 和 10B 治疗的 62.5%和 88.4%的患者，根据腹泻粪便形式的减少，被归类为粪便一致性应答者，而安慰剂组为 26.3%（<0.001）。相比之下，微生物多样性没有明显变化。
（）Lpla33（DSM34428）耐受性良好，可改善 IBS 症状严重程度，具有剂量范围效应，并使 IBS-D 成人的排便习惯正常化。
