NCT02728063

Lactibiane Tolérance® in Individuals Suffering From Irritable Bowel Syndrome With Diarrheal Predominance

Effect of a Mixture of Probiotics, Lactibiane Tolérance® on Intestinal Permeability in Individuals Suffering From Irritable Bowel Syndrome With Diarrheal Predominance

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: PiLeJe · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The main objective of the study is to evaluate the effect on intestinal permeability of a supplementation with Lactibiane Tolérance® for 4 weeks (28 days) in patients suffering from irritable bowel syndrome (IBS) with diarrhea predominance. Secondary objectives of the study are to evaluate the effects of supplementation with Lactibiane Tolérance® for 4 weeks (28 days) in patients suffering from IBS with diarrhea predominance on intestinal permeability, inflammation of the digestive tract, symptoms and comfort. Single-center study in single open arms: 30 volunteer adults suffering from Irritable Bowel Syndrome (IBS) with diarrhea predominance and matching the criteria of inclusion and non-inclusion listed below.

Detailed description

single-center pilot study in single open arm: * 2 to 6 weeks before enrollment: a screening visit (visit 0 \[V0\]) is carried out for verification of eligibility. time between V0 and V1 is a wash-out period with a duration decided by the physician (max 8 weeks). * The experimental phase is composed of 2 visits (Visit 1 \[V1\] and Visit 2 \[V2\]) separated by 28 days (± 2 days) : from V1 to V2 patients are taking the product Lactibiane Tolérance®. * V1 and V2 each include collection of stools, a blood sample, questionnaires on abdominal symptoms and quality of life, dynamic test of absorption of lactulose / mannitol to evaluate the intestinal permeability, recto-sigmoidoscopy with confocal endomicroscopy for in-vivo study of fluorescein leakage in the lamina propria and biopsies for ex-vivo measurements. * "carmine red" test for the evaluation of intestinal transit speed is carried out the week before V1 and V2 (at least 72 hours before the visit). Questionnaires on abdominal symptoms as well as the frequency and consistency of stools are filled during the 7 days before V1 and V2 before.

Conditions

• Diarrhea Predominant Irritable Bowel Syndrome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactibiane Tolerance	probiotics

Timeline

• Start date: 2016-05-11
• Primary completion: 2018-04-11
• Completion: 2018-04-11
• First posted: 2016-04-05
• Last updated: 2021-02-23

Locations

1 site across 1 country: France