Irritable Bowel Syndrome | Irritable Bowel Syndrome and Lactibiane Tolerance
Irritable Bowel Syndrome research study
What is the primary objective of this study?
The purpose of this study is to evaluate the effects of a probiotic combination (Lactibiane Tolerance) on the severity of symptoms in patients with irritable bowel syndrome (IBS).
Who is eligible to participate?
Inclusion Criteria: - Irritable bowel syndrome according to the Rome II criteria - 150< Francis Score < 300 - HAD score inferior or egal to 25 Exclusion Criteria: - History of hypersensitivity to one of the composant of the product - Use of probiotics or antibiotics last four weeks - use of prohibited drugs - bowel preparation for morphological examination last month - pregnancy or lactation - immundepressed or co-existing other serious illness or evolutive
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Irritable Bowel Syndrome
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Dietary Supplement:Lactibiane ToleranceProbiotics combination 2 gelules per days during 6 weeks
Dietary Supplement:PlaceboPlacebo 2 gelules per days for 6 weeks
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Lactibiane ToleranceProbiotics combination
Start Date: April 2010
Completed Date: December 2012
Phase: Phase 3
Primary Outcome: Severity of bowel symptoms according to the Francis Score
Secondary Outcome: Quality of life
Study sponsors, principal investigator, and references
Principal Investigator: Piche Thierry, MD
Lead Sponsor: Pileje