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

This study has been completed.
Sponsor:
Collaborator:
Alimentary Health Ltd
Information provided by:
Procter and Gamble
ClinicalTrials.gov Identifier:
NCT00135031
First received: August 23, 2005
Last updated: June 14, 2011
Last verified: June 2011
  Purpose

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).


Condition Intervention Phase
Irritable Bowel Syndrome
Drug: Bifidobacterium infantis 35624
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Safety and Efficacy Evaluation of Bifidobacterium Infantis 35624 in Female Subjects With Irritable Bowel Syndrome

Further study details as provided by Procter and Gamble:

Primary Outcome Measures:
  • The primary efficacy variable was the abdominal pain score

Secondary Outcome Measures:
  • 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

Estimated Enrollment: 362
Study Start Date: January 2004
Study Completion Date: September 2004
Primary Completion Date: September 2004 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00135031

Locations
United Kingdom
Yaxley Group Practice, The Health Centre
Peterborough, Cambridgeshire, United Kingdom, PE7 3JL
The Staploe Medical Centre
Soham, Cambridgeshire, United Kingdom, CB7 5JD
Wansford Surgery
Wansford, Cambridgeshire, United Kingdom, PE8 6PL
Old School Surgery
Greenisland, County Antrim, United Kingdom, BT38 8TP
Springhill Surgery
Bangor, County Down, United Kingdom, BT19 1PP
Downpatrick Health Centre
Downpatrick, County Down, United Kingdom, BT30 6HY
Sea Road Surgery
Bexhill-on-Sea, East Sussex, United Kingdom, TN40 1JJ
Little Common Surgery
Bexhill-on-Sea, East Sussex, United Kingdom, TN39 5JB
Valleyfield Health Centre
High Valleyfield, Fife, United Kingdom, KY 12 8SJ
Stanwell Road Surgery
Ashford, Middlesex, United Kingdom, TW18 1SL
Belmont Health Centre
Harrow, Middlesex, United Kingdom, HA3 7LT
The Frome Medical Practice
Frome, Somerset, United Kingdom, BA11 1EZ
The Burns Practice
Doncaster, South Yorkshire, United Kingdom, DN1 2EG
The Burngreave Surgery
Sheffield, South Yorkshire, United Kingdom, S3 9DA
The Medical Centre
East Horsley, Surrey, United Kingdom, KT 24 6QT
The Penylan Surgery
Cardiff, Wales, United Kingdom, CF23 5SY
Sherbourne Medical Centre
Leamington Spa, Warwickshire, United Kingdom, CV32 4RA
Hathaway Surgery
Chippenham, Wiltshire, United Kingdom, SN15 1HP
Swindon Medical Research Centre, Abbeymeads Medical
Swindon, Wiltshire, United Kingdom, SN25 4YZ
The Orchard Medical Centre
Bristol, United Kingdom, BS15 2NJ
Sponsors and Collaborators
Procter and Gamble
Alimentary Health Ltd
Investigators
Principal Investigator: Peter J. Whorwell, M.D. Department of Medicine, Education and Research Centre, Wythenshawe Hospital, Manchester M23 9LT UK
  More Information

No publications provided

Responsible Party: Linda McKean, Procter & Gamble
ClinicalTrials.gov Identifier: NCT00135031     History of Changes
Other Study ID Numbers: 2002089
Study First Received: August 23, 2005
Last Updated: June 14, 2011
Health Authority: United Kingdom: Department of Health

Additional relevant MeSH terms:
Syndrome
Irritable Bowel Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 18, 2014