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Effect and Tolerance of a Probiotic-based Medical Device Administered to Patients With Irritable Bowel Syndrome — Lactiplus  

Irritable Bowel Syndrome Clinical Trial

Official title:
Effect and Tolerance of a Probiotic-based Medical Device (Lactiplus®) Administered to Patients With Irritable Bowel Syndrome

Clinical Trial Summary

This is an observational, open, longitudinal, multicentre study conducted in France.

The study plans to enrol 119 patients with irritable bowel syndrome who will be included by about 50 general practitioners or gastroenterologists consulting in private offices. The treatment, Lactiplus® is a medical device, in the form of capsules containing L. gasseri LA806. The main objective of the study is to assess the effect of a 4-week treatment with the medical device on abdominal pain.

Clinical Trial Description

The study is designed as an observational post-market follow-up study, to confirm the performance of the medical device in real life conditions and document its safety profile.

The eligible population corresponds to the population that could benefit from the treatment, according to the MD's instructions for use. Non-inclusion criteria prevent from including patients with other pathologies associated with gastro-intestinal troubles, who may beneficiate from more adequate treatments. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04324658
Study type Observational
Source Pileje
Contact
Status Completed
Phase
Start date July 30, 2019
Completion date June 26, 2020
View Details
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