Status:
COMPLETED
Efficacy of an Encapsulated Probiotic Bifidobacterium Infantis 35624 in Irritable Bowel Syndrome
Lead Sponsor:
Procter and Gamble
Collaborating Sponsors:
Alimentary Health Ltd
Conditions:
Irritable Bowel Syndrome
Eligibility:
FEMALE
18-65 years
Phase:
PHASE3
Brief 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).
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 benefici...
Eligibility Criteria
Inclusion
- Meet Rome II criteria for the diagnosis of IBS
- Refrain from using probiotic supplements during the trial
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
September 1 2004
Estimated Enrollment :
362 Patients enrolled
Trial Details
Trial ID
NCT00135031
Start Date
January 1 2004
End Date
September 1 2004
Last Update
June 15 2011
Active Locations (20)
Enter a location and click search to find clinical trials sorted by distance.
1
The Orchard Medical Centre
Bristol, Bristol, United Kingdom, BS15 2NJ
2
Yaxley Group Practice, The Health Centre
Peterborough, Cambridgeshire, United Kingdom, PE7 3JL
3
The Staploe Medical Centre
Soham, Cambridgeshire, United Kingdom, CB7 5JD
4
Wansford Surgery
Wansford, Cambridgeshire, United Kingdom, PE8 6PL