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

NCT ID: NCT00135031

Last Updated: 2011-06-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

362 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2004-09-30

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Irritable Bowel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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Bifidobacterium infantis 35624

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Alimentary Health Ltd

INDUSTRY

Sponsor Role collaborator

Procter and Gamble

INDUSTRY

Sponsor Role lead

Responsible Party

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Procter & Gamble

Principal Investigators

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Peter J. Whorwell, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine, Education and Research Centre, Wythenshawe Hospital, Manchester M23 9LT UK

Locations

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The Orchard Medical Centre

Bristol, Bristol, United Kingdom

Site Status

Yaxley Group Practice, The Health Centre

Peterborough, Cambridgeshire, United Kingdom

Site Status

The Staploe Medical Centre

Soham, Cambridgeshire, United Kingdom

Site Status

Wansford Surgery

Wansford, Cambridgeshire, United Kingdom

Site Status

Old School Surgery

Greenisland, County Antrim, United Kingdom

Site Status

Springhill Surgery

Bangor, County Down, United Kingdom

Site Status

Downpatrick Health Centre

Downpatrick, County Down, United Kingdom

Site Status

Little Common Surgery

Bexhill-on-Sea, East Sussex, United Kingdom

Site Status

Sea Road Surgery

Bexhill-on-Sea, East Sussex, United Kingdom

Site Status

Valleyfield Health Centre

High Valleyfield, Fife, United Kingdom

Site Status

Stanwell Road Surgery

Ashford, Middlesex, United Kingdom

Site Status

Belmont Health Centre

Harrow, Middlesex, United Kingdom

Site Status

The Frome Medical Practice

Frome, Somerset, United Kingdom

Site Status

The Burns Practice

Doncaster, South Yorkshire, United Kingdom

Site Status

The Burngreave Surgery

Sheffield, South Yorkshire, United Kingdom

Site Status

The Medical Centre

East Horsley, Surrey, United Kingdom

Site Status

The Penylan Surgery

Cardiff, Wales, United Kingdom

Site Status

Sherbourne Medical Centre

Royal Leamington Spa, Warwickshire, United Kingdom

Site Status

Hathaway Surgery

Chippenham, Wiltshire, United Kingdom

Site Status

Swindon Medical Research Centre, Abbeymeads Medical

Swindon, Wiltshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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2002089

Identifier Type: -

Identifier Source: org_study_id

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