Effect of Lactobacillus Reuteri DSM 17938 on Gut Motility in Patients With Functional Constipation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Improvement in gastrointestinal symptoms after 3 months of probiotic administration
研究概览
简要总结
The diffusion of gastrointestinal (GI) chronic diseases is significantly increased during the last century in western countries. In the USA and Northern Europe, constipation is twofold the prevalence found in the East and Southern Europe. In Italy, constipation affects up to 15-17% of the whole adult population. Of them, more than half (about 10%) treats this disorder by assuming laxatives, while the remaining does not even assume drugs. A close relationship between intestinal environment and bacterial flora has been found. As a matter of fact changes in the intestinal physiology can modify the composition of bacterial flora as well as modifications in the intestinal microbiota can modify the physiology of the gut. The probiotic effects on the GI motility can be due to substances released by bacteria and/or products of their fermentation. Also, probiotic may indirectly act by the release of neuroendocrine factors and/or substances released by the immune system. Clinically, it has already been demonstrated that probiotics exert a positive effect on symptoms and intestinal habit in constipated IBS patients. In this framework, the idea to perform a long lasting intervention study in patients with functional constipation treated with probiotics sounds convincing. The present study is a randomized, double blind, placebo controlled, monocentric study, concerning the evaluation of efficacy of 3 months administration of Lactobacillus reuteri DSM 17938 in patients with functional constipation, as defined by the Rome criteria. Clinical, physiological, hematological and immunologic variables will be evaluated.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfilment of the Rome Criteria III for functional constipation
- •Availability of at least one GI imaging study during the last five years (colonoscopy, sigmoidoscopy, abdominal ultrasound, barium enema)
- •Commitment to availability for the whole study period
排除标准
- •Major abdominal surgery
- •Presence of any concomitant diseases such as organic GI diseases and/or lactose and gluten intolerance; medical or psychiatric illness
- •Alarming symptoms (rectal bleeding, weight loss, etc)
- •Family history of peptic ulcer, colorectal cancer, or IBD
- •Abnormal laboratory data or thyroid function.
结局指标
主要结局
Improvement in gastrointestinal symptoms after 3 months of probiotic administration
时间窗: Before the start of the study (Time 0) and after 90 days of treatment (Time 90)
Validated and structured questionnaires to evaluate gastrointestinal symptoms, to confirm functional constipation diagnosis and to exclude IBS variant constipation. Score of gastrointestinal symptoms with Gastrointestinal Symptom Rating Score (GSRS); Constipation Symptom Score (CSS); Constipation QoL, Constipation Rome criteria, Diary for the symptoms and for intestinal behavior. These questionnaires will be administered at baseline, after 45 days of treatment, and at the end of treatment.
次要结局
- Changes in metabolic parameters after 3 months of probiotic administration(Before the start of the study (time 0) and after 90 days of treatment (Time 90))
- Changes in physiological parameters after 3 months of probiotic administration(Before the start of the study (Time 0) and after 90 days of treatment (Time 90))
研究者
Francesco Russo
MD
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis