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

Irritable Bowel Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00135031
• Other study ID #: 2002089
• Status: Completed
• Phase: Phase 3
• First received: August 23, 2005
• Last updated: June 14, 2011
• Start date: January 2004
• Est. completion date: September 2004

Study information

• Verified date: June 2011
• Source: Procter and Gamble
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Department of Health
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 362
• Est. completion date: September 2004
• Est. primary completion date: September 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• Bifidobacterium infantis 35624

Locations

Country	Name	City	State
United Kingdom	Stanwell Road Surgery	Ashford	Middlesex
United Kingdom	Springhill Surgery	Bangor	County Down
United Kingdom	Little Common Surgery	Bexhill-on-Sea	East Sussex
United Kingdom	Sea Road Surgery	Bexhill-on-Sea	East Sussex
United Kingdom	The Orchard Medical Centre	Bristol
United Kingdom	The Penylan Surgery	Cardiff	Wales
United Kingdom	Hathaway Surgery	Chippenham	Wiltshire
United Kingdom	The Burns Practice	Doncaster	South Yorkshire
United Kingdom	Downpatrick Health Centre	Downpatrick	County Down
United Kingdom	The Medical Centre	East Horsley	Surrey
United Kingdom	The Frome Medical Practice	Frome	Somerset
United Kingdom	Old School Surgery	Greenisland	County Antrim
United Kingdom	Belmont Health Centre	Harrow	Middlesex
United Kingdom	Valleyfield Health Centre	High Valleyfield	Fife
United Kingdom	Sherbourne Medical Centre	Leamington Spa	Warwickshire
United Kingdom	Yaxley Group Practice, The Health Centre	Peterborough	Cambridgeshire
United Kingdom	The Burngreave Surgery	Sheffield	South Yorkshire
United Kingdom	The Staploe Medical Centre	Soham	Cambridgeshire
United Kingdom	Swindon Medical Research Centre, Abbeymeads Medical	Swindon	Wiltshire
United Kingdom	Wansford Surgery	Wansford	Cambridgeshire

Sponsors (2)

Lead Sponsor	Collaborator
Procter and Gamble	Alimentary Health Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy variable was the abdominal pain score
Secondary	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