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

June 14, 2011 updated by: Procter and Gamble

A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Safety and Efficacy Evaluation of Bifidobacterium Infantis 35624 in Female Subjects With Irritable Bowel Syndrome

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The pathogenesis of irritable bowel syndrome (IBS) may have a a post-infectious inflammatory component, suggesting that altered gut bacterial flora are of relevance and that probiotics may be beneficial. This clinical trial examined the efficacy of an encapsulated probiotic in subjects with Rome II IBS. After a 2 week baseline, 362 female subjects were randomized to placebo or one of three doses of B. infantis 35624 once daily for 4 weeks. IBS symptoms were monitored daily and scored according to a 6-point Likert scale; stool frequency and form were also monitored daily. The primary efficacy variable was the abdominal pain score; secondary efficacy variables included other IBS symptom relief and quality of life.

Study Type

Interventional

Enrollment

362

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Bristol, United Kingdom, BS15 2NJ
        • The Orchard Medical Centre
    • Cambridgeshire
      • Peterborough, Cambridgeshire, United Kingdom, PE7 3JL
        • Yaxley Group Practice, The Health Centre
      • Soham, Cambridgeshire, United Kingdom, CB7 5JD
        • The Staploe Medical Centre
      • Wansford, Cambridgeshire, United Kingdom, PE8 6PL
        • Wansford Surgery
    • County Antrim
      • Greenisland, County Antrim, United Kingdom, BT38 8TP
        • Old School Surgery
    • County Down
      • Bangor, County Down, United Kingdom, BT19 1PP
        • Springhill Surgery
      • Downpatrick, County Down, United Kingdom, BT30 6HY
        • Downpatrick Health Centre
    • East Sussex
      • Bexhill-on-Sea, East Sussex, United Kingdom, TN39 5JB
        • Little Common Surgery
      • Bexhill-on-Sea, East Sussex, United Kingdom, TN40 1JJ
        • Sea Road Surgery
    • Fife
      • High Valleyfield, Fife, United Kingdom, KY 12 8SJ
        • Valleyfield Health Centre
    • Middlesex
      • Ashford, Middlesex, United Kingdom, TW18 1SL
        • Stanwell Road Surgery
      • Harrow, Middlesex, United Kingdom, HA3 7LT
        • Belmont Health Centre
    • Somerset
      • Frome, Somerset, United Kingdom, BA11 1EZ
        • The Frome Medical Practice
    • South Yorkshire
      • Doncaster, South Yorkshire, United Kingdom, DN1 2EG
        • The Burns Practice
      • Sheffield, South Yorkshire, United Kingdom, S3 9DA
        • The Burngreave Surgery
    • Surrey
      • East Horsley, Surrey, United Kingdom, KT 24 6QT
        • The Medical Centre
    • Wales
      • Cardiff, Wales, United Kingdom, CF23 5SY
        • The Penylan Surgery
    • Warwickshire
      • Leamington Spa, Warwickshire, United Kingdom, CV32 4RA
        • Sherbourne Medical Centre
    • Wiltshire
      • Chippenham, Wiltshire, United Kingdom, SN15 1HP
        • Hathaway Surgery
      • Swindon, Wiltshire, United Kingdom, SN25 4YZ
        • Swindon Medical Research Centre, Abbeymeads Medical

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Meet Rome II criteria for the diagnosis of IBS
  • Refrain from using probiotic supplements during the trial

Exclusion Criteria:

  • Organic diseases, including inflammatory bowel disease, and significant systemic diseases
  • Subjects over 55 years of age that had not had a sigmoidoscopy or colonoscopy performed in the previous five years
  • Use of anti-psychotic medications within the prior three months
  • Had major psychiatric disorder (DSM-II-R or DSM-IV), including major depression, psychoses, alcohol or substance abuse, within the past two years
  • Were pregnant or nursing
  • Had known lactose intolerance or immunodeficiency
  • Had undergone any abdominal surgery, with the exception of hernia repair or appendectomy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary efficacy variable was the abdominal pain score

Secondary Outcome Measures

Outcome Measure
Bloating/distension, sense of incomplete evacuation, straining, urgency, passage of gas, number of bowel movements, passage of mucus, a composite symptom score, subject's assessment of IBS symptom relief, and quality of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Procter and Gamble

Collaborators

Alimentary Health Ltd

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

September 1, 2004

Study Completion (Actual)

September 1, 2004

Study Registration Dates

First Submitted

August 23, 2005

First Submitted That Met QC Criteria

August 23, 2005

First Posted (Estimate)

August 25, 2005

Study Record Updates

Last Update Posted (Estimate)

June 15, 2011

Last Update Submitted That Met QC Criteria

June 14, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2002089

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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