Irritable Bowel Syndrome and Lactibiane Tolerance

PiLeJe

Status: Completed

Conditions: Irritable Bowel Syndrome

Treatments: Dietary Supplement: Lactibiane Tolerance; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01529359

PiLeJe-LactiTol-0210

Details and patient eligibility

About

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).

Full 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

Enrollment: 123 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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123 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Probiotics Excipients

Treatment:

Dietary Supplement: Placebo

Lactibiane Tolerance

Experimental group

Description:

Probiotics combination

Treatment:

Dietary Supplement: Lactibiane Tolerance