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

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

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2010-06-30

Brief Summary

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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.

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Detailed Description

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

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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Lactobacillus FARCIMINIS

Group Type EXPERIMENTAL

Lactobacillus FARCIMINIS

Intervention Type DIETARY_SUPPLEMENT

10.10 UFC of lactobacillus FARCIMINIS

B

Placebo

Group Type PLACEBO_COMPARATOR

placebo (starch)

Intervention Type DIETARY_SUPPLEMENT

Once daily

Interventions

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Lactobacillus FARCIMINIS

10.10 UFC of lactobacillus FARCIMINIS

Intervention Type DIETARY_SUPPLEMENT

placebo (starch)

Once daily

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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10.10 UFC of lactobacillus FARCIMINIS Once daily

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No