A Novel Formulation of Bifidobacterium Longum BB536 and Lactobacillus Rhamnosus HN001 With Vitamin B6 on IBS Patients (LLB)

NCT03815617 PHASE3 COMPLETED

Irritable bowel syndrome (IBS) is one of the most frequent functional gastrointestinal disorder with a prevalence ranging from 10 to 15 percent. IBS results from an interaction among several factors, including genetic predisposition, gastrointestinal motility, visceral hypersensitivity, immune activation with minimal inflammation, alterations in intestinal microbiota, increased intestinal permeability, and food sensitivity. Of note, the management of patients with IBS is critical. Since quantitative and qualitative disturbances of intestinal microbiota can occur in IBS, interesting data support the use of probiotics to modulate intestinal microbiota. The present study aimed to investigate the effects of a novel formulation of B. longum BB536 and L. rhamnosus HN001 with vitamin B6 on the gut microbiota and intestinal permeability in IBS subjects.

Details

Lead sponsor	University of Bari
Phase	PHASE3
Status	COMPLETED
Enrolment	25
Start date	Wed Feb 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Mon Dec 31 2018 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Irritable Bowel Syndrome

Interventions

• Zircombi
• Placebo

Countries

Italy