Irritable Bowel Syndrome and Lactibiane Tolerance

Not Applicable

Completed

• Conditions: Irritable Bowel Syndrome

• Registration Number: NCT01529359
• Lead Sponsor: PiLeJe

Brief Summary

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).

Detailed Description

The primary 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).

The secondary purposes are to evaluate the effects of the intervention on:

* quality of life

* severity of fatigue, anxiety and depression

* levels of inflammatory markers in blood and tools

Study Timeline

• Study Start: 2010-03-24
• Study First Submitted: 2011-10-10
• Study First Submitted QC: 2012-02-06
• Study First Posted: 2012-02-08
• Primary Completion: 2013-02-04
• Study Completion: 2013-02-11
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-19
• Last Update Posted: 2021-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 123

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Severity of bowel symptoms according to the Francis Score	After 6 weeks of complementation	The severity of bowel symptoms is evaluated with a quality of life questionnaire, the Francis Score before and after 6 weeks of complementation in placebo and verum groups.

Secondary Outcome Measures

Name	Time	Method
Impact of the intervention on immunological parameters in blood	after 2 weeks of wash-out	The impact of the intervention on immunological parameters in blood will be measured with levels of endotoxines, ultrasensitive protein C Reactive and cytokines
Severity of Anxiety/Depression	after 6 weeks of complementation	The level of anxiety/depression will be measured with the HAD scale
Impact of the complementation on fatigue	After 2 weeks of wash out	The level of fatigue will be measured with the score to the fatigue Impact Scale (FIS)
Quality of life	after 2 weeks of wash-out	Effect of the intervention on transit and abdominal pain
Severity of bowel symptoms according to the Francis Score	after 2 weeks of wash-out	The severity of bowel symptoms is evaluated with the Francis Score before 6 weeks of complementation and after 2 weeks of wash-out in placebo and verum groups
severity of the anxiety/depression	after 2 weeks of wash-out	The level of anxiety/depression will be measured with the HAD scale
Impact of the intervention on immunological parameters in stools	after 2 weeks of wash out	The effects of the intervention on immunological parameters in stools will be avaluated via the levels of beta-defensine 2 and sérine protease activities

Trial Locations

Locations (1)

Chu L'Archet 2; 🇫🇷 Nice, Alpes Maritimes, France