Irritable Bowel Syndrome and Lactibiane Tolerance

PiLeJe123 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

123

Conditions

Irritable Bowel Syndrome

Interventions

Lactibiane ToleranceDIETARY_SUPPLEMENT

Probiotics combination 2 gelules per days during 6 weeks

PlaceboDIETARY_SUPPLEMENT

Placebo 2 gelules per days for 6 weeks

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Chu L'Archet 2

Nice, Alpes Maritimes, France

Outcomes

Primary Outcomes

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.

Time frame: After 6 weeks of complementation