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Completed

NCT Number: NCT00561535

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

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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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Diarrhea Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hopital Louis Mourier, GI Unit

Colombes, Île-de-France Region, 92700, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lactobacillus FARCIMINIS

Dietary Supplement

10.10 UFC of lactobacillus FARCIMINIS

Other names: 10.10 UFC of lactobacillus FARCIMINIS

placebo (starch)

Dietary Supplement

Once daily

Other names: Once daily

Primary outcomes

  1. Overall subject's assessment

    Time frame: 4 weeks

Secondary outcomes

  1. Decrease in abdominal pain, stool form and consistency, modifications in intestinal permeability, modification in fecal serine protease activity, modifications in interleukin seric concentrations

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Association pour l'Etude des Fonctions Digestives

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Nov 21, 2007
Registry last updated
Jan 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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