NCT04324658

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 119 (actual)
• Sponsor: PiLeJe · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Irritable Bowel Syndrome

Interventions

Type	Name	Description
DEVICE	Lactiplus	capsules containing L. gasseri LA806

Timeline

• Start date: 2019-07-30
• Primary completion: 2020-06-26
• Completion: 2020-06-26
• First posted: 2020-03-27
• Last updated: 2020-09-29

Locations

1 site across 1 country: France