Effect of a Probiotic, Lactobacillus FARCIMINIS, in Diarrhea Predominant IBS Patients

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 2

Conditions: Irritable Bowel Syndrome

Treatments: Dietary Supplement: placebo (starch); Dietary Supplement: Lactobacillus FARCIMINIS

Study type: Interventional

Funder types: Other

Identifiers

NCT00561535

AEFD 2007-01

Details and patient eligibility

About

Probiotics may improve symptoms in IBS patients. The aim of this study is to test the efficacy of Lactobacillus FARCIMINIS in diarrhea predominant IBS patients according to Rome III criteria.

Full description

The aim of this study is to test the efficacy of Lactobacillus FARCIMINIS in diarrhea predominant IBS patients according to Rome III criteria.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diarrhea predominant IBS
• Less than 5-year duration
• Pain intensity between 2 and 7 on VAS

Exclusion criteria

• Celiac disease
• Antibiotic treatment within the 1-month period preceding inclusion
• Digestive organic disease
• Any severe non digestive organic disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

A

Experimental group

Description:

Lactobacillus FARCIMINIS

Treatment:

Dietary Supplement: Lactobacillus FARCIMINIS

B

Placebo Comparator group

Description:

Placebo

Treatment:

Dietary Supplement: placebo (starch)