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

Primary Purpose

Irritable Bowel Syndrome

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Bifidobacterium infantis 35624
Sponsored by
Procter and Gamble
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Yaxley Group Practice, The Health Centre
  • The Staploe Medical Centre
  • Wansford Surgery
  • Old School Surgery
  • Springhill Surgery
  • Downpatrick Health Centre
  • Little Common Surgery
  • Sea Road Surgery
  • Valleyfield Health Centre
  • Stanwell Road Surgery
  • Belmont Health Centre
  • The Frome Medical Practice
  • The Burns Practice
  • The Burngreave Surgery
  • The Medical Centre
  • The Penylan Surgery
  • Sherbourne Medical Centre
  • Hathaway Surgery
  • Swindon Medical Research Centre, Abbeymeads Medical
  • The Orchard Medical Centre

Outcomes

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

Full Information

First Posted
August 23, 2005
Last Updated
June 14, 2011
Sponsor
Procter and Gamble
Collaborators
Alimentary Health Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT00135031
Brief Title
Efficacy of an Encapsulated Probiotic Bifidobacterium Infantis 35624 in Irritable Bowel Syndrome
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 Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
September 2004 (Actual)
Study Completion Date
September 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Procter and Gamble
Collaborators
Alimentary Health Ltd

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
362 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Bifidobacterium infantis 35624
Primary Outcome Measure Information:
Title
The primary efficacy variable was the abdominal pain score
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter J. Whorwell, M.D.
Organizational Affiliation
Department of Medicine, Education and Research Centre, Wythenshawe Hospital, Manchester M23 9LT UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yaxley Group Practice, The Health Centre
City
Peterborough
State/Province
Cambridgeshire
ZIP/Postal Code
PE7 3JL
Country
United Kingdom
Facility Name
The Staploe Medical Centre
City
Soham
State/Province
Cambridgeshire
ZIP/Postal Code
CB7 5JD
Country
United Kingdom
Facility Name
Wansford Surgery
City
Wansford
State/Province
Cambridgeshire
ZIP/Postal Code
PE8 6PL
Country
United Kingdom
Facility Name
Old School Surgery
City
Greenisland
State/Province
County Antrim
ZIP/Postal Code
BT38 8TP
Country
United Kingdom
Facility Name
Springhill Surgery
City
Bangor
State/Province
County Down
ZIP/Postal Code
BT19 1PP
Country
United Kingdom
Facility Name
Downpatrick Health Centre
City
Downpatrick
State/Province
County Down
ZIP/Postal Code
BT30 6HY
Country
United Kingdom
Facility Name
Little Common Surgery
City
Bexhill-on-Sea
State/Province
East Sussex
ZIP/Postal Code
TN39 5JB
Country
United Kingdom
Facility Name
Sea Road Surgery
City
Bexhill-on-Sea
State/Province
East Sussex
ZIP/Postal Code
TN40 1JJ
Country
United Kingdom
Facility Name
Valleyfield Health Centre
City
High Valleyfield
State/Province
Fife
ZIP/Postal Code
KY 12 8SJ
Country
United Kingdom
Facility Name
Stanwell Road Surgery
City
Ashford
State/Province
Middlesex
ZIP/Postal Code
TW18 1SL
Country
United Kingdom
Facility Name
Belmont Health Centre
City
Harrow
State/Province
Middlesex
ZIP/Postal Code
HA3 7LT
Country
United Kingdom
Facility Name
The Frome Medical Practice
City
Frome
State/Province
Somerset
ZIP/Postal Code
BA11 1EZ
Country
United Kingdom
Facility Name
The Burns Practice
City
Doncaster
State/Province
South Yorkshire
ZIP/Postal Code
DN1 2EG
Country
United Kingdom
Facility Name
The Burngreave Surgery
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S3 9DA
Country
United Kingdom
Facility Name
The Medical Centre
City
East Horsley
State/Province
Surrey
ZIP/Postal Code
KT 24 6QT
Country
United Kingdom
Facility Name
The Penylan Surgery
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF23 5SY
Country
United Kingdom
Facility Name
Sherbourne Medical Centre
City
Leamington Spa
State/Province
Warwickshire
ZIP/Postal Code
CV32 4RA
Country
United Kingdom
Facility Name
Hathaway Surgery
City
Chippenham
State/Province
Wiltshire
ZIP/Postal Code
SN15 1HP
Country
United Kingdom
Facility Name
Swindon Medical Research Centre, Abbeymeads Medical
City
Swindon
State/Province
Wiltshire
ZIP/Postal Code
SN25 4YZ
Country
United Kingdom
Facility Name
The Orchard Medical Centre
City
Bristol
ZIP/Postal Code
BS15 2NJ
Country
United Kingdom

12. IPD Sharing Statement

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

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