Irritable Bowel Syndrome and Lactibiane Tolerance

Effect of Lactibiane Tolerance on Symptoms Severity of Irritable Bowel Syndrome

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).

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Lactibiane Tolerance

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 Type: Interventional
• Enrollment (Actual): 123
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Alpes Maritimes
    • Nice, Alpes Maritimes, France, 06200
      • Chu L'Archet 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Probiotics Excipients	Dietary supplement: Placebo; Placebo 2 gelules per days for 6 weeks
Experimental: Lactibiane Tolerance; Probiotics combination	Dietary supplement: Lactibiane Tolerance; Probiotics combination 2 gelules per days during 6 weeks; Other Names: Probiotic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of bowel symptoms according to the Francis Score	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.	After 6 weeks of complementation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: PiLeJe
• Investigators: Principal Investigator: Piche Thierry, MD

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2010
• Primary Completion (Actual): February 4, 2013
• Study Completion (Actual): February 11, 2013

Study Registration Dates

• First Submitted: October 10, 2011
• First Submitted That Met QC Criteria: February 6, 2012
• First Posted (Estimate): February 8, 2012

Study Record Updates

• Last Update Posted (Actual): April 20, 2021
• Last Update Submitted That Met QC Criteria: April 19, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Irritable Bowel Syndrome; Probiotics
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: PiLeJe-LactiTol-0210