临床试验/NCT00561535

NCT00561535已完成2 期

Effect of a Probiotic, Lactobacillus FARCIMINIS, in Diarrhea Predominant IBS

Assistance Publique - Hôpitaux de Paris2 个研究点分布在 1 个国家目标入组 60 人开始时间: 2007年10月最近更新: 2011年1月27日

适应症

试验速览

阶段: 2 期
状态: 已完成
发起方: Assistance Publique - Hôpitaux de Paris
入组人数: 60
试验地点: 2
主要终点: Overall subject's assessment

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Probiotics may improve symptoms in IBS patients. The aim of this study is to test the efficacy of Lactobacillus FARCIMINIS in diarrhea predominant IBS patients according to Rome III criteria.

详细描述

The aim of this study is to test the efficacy of Lactobacillus FARCIMINIS in diarrhea predominant IBS patients according to Rome III criteria.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Diarrhea predominant IBS
•Less than 5-year duration
•Pain intensity between 2 and 7 on VAS

排除标准

•Celiac disease
•Antibiotic treatment within the 1-month period preceding inclusion
•Digestive organic disease
•Any severe non digestive organic disease

结局指标

主要结局

Overall subject's assessment

时间窗: 4 weeks

次要结局

Decrease in abdominal pain, stool form and consistency, modifications in intestinal permeability, modification in fecal serine protease activity, modifications in interleukin seric concentrations(4 weeks)

研究者

发起方

Assistance Publique - Hôpitaux de Paris

申办方类型

Other

研究点 (2)

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