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Irritable Bowel Syndrome and Lactibiane Tolerance

Primary Purpose

Irritable Bowel Syndrome

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

Lactibiane Tolerance

Placebo

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Irritable Bowel Syndrome, Probiotics

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Chu L'Archet 2

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Lactibiane Tolerance

Arm Description

Probiotics Excipients

Probiotics combination

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Quality of life

Effect of the intervention on transit and abdominal pain

Severity of Anxiety/Depression

The level of anxiety/depression will be measured with the HAD scale

Impact of the complementation on fatigue

The level of fatigue will be measured with the score to the fatigue Impact Scale (FIS)

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

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

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

Quality of life

Effect of the intervention on transit and abdominal pain

severity of the anxiety/depression

The level of anxiety/depression will be measured with the HAD scale

Impact of the complementation on fatigue

The level of fatigue will be measured with the score to the fatigue Impact Scale (FIS)

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

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

Full Information

NCT ID

NCT01529359

First Posted

October 10, 2011

Last Updated

April 19, 2021

Sponsor

PiLeJe

1. Study Identification

Unique Protocol Identification Number

NCT01529359

Brief Title

Irritable Bowel Syndrome and Lactibiane Tolerance

Official Title

Effect of Lactibiane Tolerance on Symptoms Severity of Irritable Bowel Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

March 24, 2010 (Actual)

Primary Completion Date

February 4, 2013 (Actual)

Study Completion Date

February 11, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

PiLeJe

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Irritable Bowel Syndrome

Keywords

Irritable Bowel Syndrome, Probiotics

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

123 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Probiotics Excipients

Arm Title

Lactibiane Tolerance

Arm Type

Experimental

Arm Description

Probiotics combination

Intervention Type

Dietary Supplement

Intervention Name(s)

Lactibiane Tolerance

Other Intervention Name(s)

Probiotic

Intervention Description

Probiotics combination 2 gelules per days during 6 weeks

Intervention Type

Dietary Supplement

Intervention Name(s)

Placebo

Intervention Description

Placebo 2 gelules per days for 6 weeks

Primary Outcome Measure Information:

Title

Severity of bowel symptoms according to the Francis Score

Description

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.

Time Frame

After 6 weeks of complementation

Secondary Outcome Measure Information:

Title

Quality of life

Description

Effect of the intervention on transit and abdominal pain

Time Frame