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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00561535
Enrollment
60
Registered
2007-11-21
Start date
2007-10-31
Completion date
2010-06-30
Last updated
2011-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome

Keywords

IBS, Diarrhea, Rome III

Brief summary

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.

Detailed description

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

Interventions

DIETARY_SUPPLEMENTLactobacillus FARCIMINIS

10.10 UFC of lactobacillus FARCIMINIS

DIETARY_SUPPLEMENTplacebo (starch)

Once daily

Sponsors

Association pour l'Etude des Fonctions Digestives
CollaboratorUNKNOWN
Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Overall subject's assessment4 weeks

Secondary

MeasureTime frame
Decrease in abdominal pain, stool form and consistency, modifications in intestinal permeability, modification in fecal serine protease activity, modifications in interleukin seric concentrations4 weeks

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026