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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00135031
Recruitment Status : Completed
First Posted : August 25, 2005
Last Update Posted : June 15, 2011
Alimentary Health Ltd
Information provided by:
Procter and Gamble

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).

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Drug: Bifidobacterium infantis 35624 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 362 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : January 2004
Actual Primary Completion Date : September 2004
Actual Study Completion Date : September 2004

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

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00135031

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Sponsors and Collaborators
Procter and Gamble
Alimentary Health Ltd
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Principal Investigator: Peter J. Whorwell, M.D. Department of Medicine, Education and Research Centre, Wythenshawe Hospital, Manchester M23 9LT UK
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Responsible Party: Linda McKean, Procter & Gamble Identifier: NCT00135031    
Other Study ID Numbers: 2002089
First Posted: August 25, 2005    Key Record Dates
Last Update Posted: June 15, 2011
Last Verified: June 2011
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases