Sadrin S, Sennoune S R, Gout B, Marque S, Moreau J, Grillasca J, Pons O, Maixent J M
Laboratoire PROTEE - EA 3819-EBMM-Bâtiment R, Université du Sud Toulon-Var, BP 20132, 83957 La Garde Cedex, France.
Department of Cellular Physiology and Molecular Biophysics - Health Sciences Center, Texas Tech University, 3601 4th Street, Lubbock, TX 79430-6551, USA.
Cell Mol Biol (Noisy-le-grand). 2017 Sep 30;63(9):122-131. doi: 10.14715/cmb/2017.63.9.21.
Irritable bowel syndrome is a chronic functional gastrointestinal disorder characterized by abdominal pain/discomfort and altered bowel habits. The use of Lactobacilli as probiotics during irritable bowel syndrome is based on their interesting mechanisms of action and their excellent safety profile but little is known about their clinical efficacy due to the lack of adequately designed clinical trials. The current clinical trial protocol aims to determine the effects of a mixture of Lactobacillus acidophilus NCFM and LAFTI L10 as probiotics to improve irritable bowel syndrome symptoms (LAPIBSS). Eighty patients with a positive diagnosis of irritable bowel syndrome according to Rome III criteria were recruited to a multicentre, double-blinded, in parallel groups, placebo-controlled randomized trial. Patients were provided with a daily dose of two capsules with two strains of Lactobacilli (5x109cfu/capsule) or placebo for 8 weeks on a 1:1 ratio. The primary outcome is to obtain scores of abdominal pain/discomfort assessed with a 100-mm visual analogue scale. The secondary outcome is to obtain scores of bloating, flatus and rumbling tested with a 100-mm visual analogue scale, composite score, stool frequency and stool consistency/appearance assessed with the Bristol Stool Form scale. According to the hypothesis that abdominal pain is mainly the result of a visceral hypersensitivity, the current study protocol aims to provide high quality proof of concept data to elucidate the efficacy of a consumption of a mixture of Lactobacillus acidophilus probiotic strains after 8 weeks, for decreasing abdominal pain. Ethical approval was given by ethics committee French Consultative Committee for the Protection of Individuals in Biomedical Research of the South West (Number CPP08-014a) and ANSM (French National Agency for Medicines and Health Products Safety - Number B80623-40). The findings from LAPBISS will be disseminated through peer-reviewed publications and at scientific conferences.
EudraCT N°2008-A00844-51.
肠易激综合征是一种慢性功能性胃肠疾病，其特征为腹痛/不适和排便习惯改变。在肠易激综合征期间使用乳酸杆菌作为益生菌，是基于其有趣的作用机制和良好的安全性，但由于缺乏设计充分的临床试验，对其临床疗效了解甚少。当前的临床试验方案旨在确定嗜酸乳杆菌NCFM和LAFTI L10的混合物作为益生菌对改善肠易激综合征症状（LAPIBSS）的效果。根据罗马III标准，80例确诊为肠易激综合征的患者被纳入一项多中心、双盲、平行组、安慰剂对照的随机试验。患者按1:1比例每日服用两粒含有两种乳酸杆菌菌株（5x109cfu/胶囊）的胶囊或安慰剂，持续8周。主要结局是用100毫米视觉模拟量表评估腹痛/不适得分。次要结局是用100毫米视觉模拟量表测试腹胀、肠胃气胀和咕噜声得分、综合得分、用布里斯托大便形状量表评估的排便频率和大便稠度/外观。根据腹痛主要是内脏超敏反应结果的假设，当前研究方案旨在提供高质量的概念验证数据，以阐明服用嗜酸乳杆菌益生菌菌株混合物8周后减轻腹痛的疗效。法国西南部生物医学研究中保护个人的伦理咨询委员会（编号CPP08 - 014a）和法国国家药品与健康产品安全局（编号B80623 - 40）给予了伦理批准。LAPBISS的研究结果将通过同行评审出版物和科学会议进行传播。
EudraCT编号2008 - A00844 - 51。
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