Irritable Bowel Syndrome and Lactibiane Tolerance

NCT ID: NCT01529359

Last Updated: 2021-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-24

Study Completion Date

2013-02-11

Brief Summary

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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

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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

Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Probiotics Excipients

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo 2 gelules per days for 6 weeks

Lactibiane Tolerance

Probiotics combination

Group Type EXPERIMENTAL

Lactibiane Tolerance

Intervention Type DIETARY_SUPPLEMENT

Probiotics combination 2 gelules per days during 6 weeks

Interventions

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Lactibiane Tolerance

Probiotics combination 2 gelules per days during 6 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo 2 gelules per days for 6 weeks

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Probiotic

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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PiLeJe

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Piche Thierry, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

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Chu L'Archet 2

Nice, Alpes Maritimes, France

Site Status

Countries

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France

Other Identifiers

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PiLeJe-LactiTol-0210

Identifier Type: -

Identifier Source: org_study_id

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