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Efficacy of an Encapsulated Probiotic Bifidobacterium Infantis 35624 in Irritable Bowel Syndrome

NCT00135031 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 362

Last updated 2011-06-15

No results posted yet for this study

Summary

The purpose of this study was to determine the dose-ranging efficacy and safety profile of encapsulated Bifidobacterium infantis 35624 in female subjects with irritable bowel syndrome (IBS).

Conditions

  • Irritable Bowel Syndrome

Interventions

DRUG

Bifidobacterium infantis 35624

Sponsors & Collaborators

  • Alimentary Health Ltd

    collaborator INDUSTRY

  • Procter and Gamble

    lead INDUSTRY

Principal Investigators

  • Peter J. Whorwell, M.D. · Department of Medicine, Education and Research Centre, Wythenshawe Hospital, Manchester M23 9LT UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Primary Completion
2004-09-30
Completion
2004-09-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00135031 on ClinicalTrials.gov