Efficacy of an Encapsulated Probiotic Bifidobacterium Infantis 35624 in Irritable Bowel Syndrome
This study has been completed.
Sponsor:
Procter and Gamble
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
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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) |
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
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:
|
Irritable Bowel Syndrome Colonic Diseases, Functional Colonic Diseases |
Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013