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Lactobacillus Reuteri DSM 17938 in Functional Constipation

NCT01244945 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2014-03-27

No results posted yet for this study

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.

Conditions

  • Functional Constipation

Interventions

DIETARY_SUPPLEMENT

L. reuteri DSM 17938

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.

OTHER

Placebo Group

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

Sponsors & Collaborators

  • Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis

    lead OTHER

Principal Investigators

  • Giuseppe Riezzo, M.D. · Azienda Ospedaliera Specializzata in Gastroenterologia IRCCS "Saverio de Bellis"

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-01-31
Primary Completion
2013-12-31
Completion
2014-01-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01244945 on ClinicalTrials.gov