Clinical trial NCT00135031: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Irritable Bowel Syndrome
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
Collaborators: name: Alimentary Health Ltd
First posted: 2005-08-25
Enrollment: 362
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The primary efficacy variable was the abdominal pain score
Secondary outcomes:
measure: 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
Other outcomes:
Locations:
city: Peterborough
country: United Kingdom
facility: Yaxley Group Practice, The Health Centre
state: Cambridgeshire
city: Soham
country: United Kingdom
facility: The Staploe Medical Centre
state: Cambridgeshire
city: Wansford
country: United Kingdom
facility: Wansford Surgery
state: Cambridgeshire
city: Greenisland
country: United Kingdom
facility: Old School Surgery
state: County Antrim
city: Bangor
country: United Kingdom
facility: Springhill Surgery
state: County Down
city: Downpatrick
country: United Kingdom
facility: Downpatrick Health Centre
state: County Down
city: Bexhill-on-Sea
country: United Kingdom
facility: Little Common Surgery
state: East Sussex
city: Bexhill-on-Sea
country: United Kingdom
facility: Sea Road Surgery
state: East Sussex
city: High Valleyfield
country: United Kingdom
facility: Valleyfield Health Centre
state: Fife
city: Ashford
country: United Kingdom
facility: Stanwell Road Surgery
state: Middlesex
city: Harrow
country: United Kingdom
facility: Belmont Health Centre
state: Middlesex
city: Frome
country: United Kingdom
facility: The Frome Medical Practice
state: Somerset
city: Doncaster
country: United Kingdom
facility: The Burns Practice
state: South Yorkshire
city: Sheffield
country: United Kingdom
facility: The Burngreave Surgery
state: South Yorkshire
city: East Horsley
country: United Kingdom
facility: The Medical Centre
state: Surrey
city: Cardiff
country: United Kingdom
facility: The Penylan Surgery
state: Wales
city: Leamington Spa
country: United Kingdom
facility: Sherbourne Medical Centre
state: Warwickshire
city: Chippenham
country: United Kingdom
facility: Hathaway Surgery
state: Wiltshire
city: Swindon
country: United Kingdom
facility: Swindon Medical Research Centre, Abbeymeads Medical
state: Wiltshire
city: Bristol
country: United Kingdom
facility: The Orchard Medical Centre
Study officials:
affiliation: Department of Medicine, Education and Research Centre, Wythenshawe Hospital, Manchester M23 9LT UK
name: Peter J. Whorwell, M.D.
role: PRINCIPAL_INVESTIGATOR
References: