CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 72 enrolled
Drug / intervention
L. reuteri DSM 17938 +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01244945
NCT01244945Phase 4Completed

Effect of Lactobacillus Reuteri DSM 17938 on Gut Motility in Patients With Functional Constipation

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis·interventional·Posted Nov 22, 2010·Updated Mar 27, 2014

In Brief

A Phase 4 clinical trial evaluating L. reuteri DSM 17938 and Placebo Group for Functional Constipation. Completed, enrolled 72 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly
Collaborators--

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 22, 2010
Enrollment StartJan 1, 2011
Primary CompletionDec 1, 2013
Study CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 15.6 years ago

Interventions

L. reuteri DSM 17938dietary

L. reuteri will be administered at 1x10\^8 CFU dosage in form of tabs. In order to ensure colonization (run in), 4 tabs will be administered per os daily (4x10\^8CFU/die) for 15 days. Then administration will continue with 2 tabs daily (2x10\^8 CFU/die) for 90 days.

Placebo Groupother

Placebo tabs identical in form, taste and consistency to active tabs