Efficacy of an Encapsulated Probiotic Bifidobacterium Infantis 35624 in Irritable Bowel Syndrome
- Conditions
- Irritable Bowel Syndrome
- Registration Number
- NCT00135031
- Lead Sponsor
- 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).
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 362
- Meet Rome II criteria for the diagnosis of IBS
- Refrain from using probiotic supplements during the trial
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The primary efficacy variable was the abdominal pain score
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (20)
The Penylan Surgery
🇬🇧Cardiff, Wales, United Kingdom
Yaxley Group Practice, The Health Centre
🇬🇧Peterborough, Cambridgeshire, United Kingdom
Wansford Surgery
🇬🇧Wansford, Cambridgeshire, United Kingdom
The Staploe Medical Centre
🇬🇧Soham, Cambridgeshire, United Kingdom
Old School Surgery
🇬🇧Greenisland, County Antrim, United Kingdom
Downpatrick Health Centre
🇬🇧Downpatrick, County Down, United Kingdom
Springhill Surgery
🇬🇧Bangor, County Down, United Kingdom
Sea Road Surgery
🇬🇧Bexhill-on-Sea, East Sussex, United Kingdom
Little Common Surgery
🇬🇧Bexhill-on-Sea, East Sussex, United Kingdom
Valleyfield Health Centre
🇬🇧High Valleyfield, Fife, United Kingdom
The Frome Medical Practice
🇬🇧Frome, Somerset, United Kingdom
Belmont Health Centre
🇬🇧Harrow, Middlesex, United Kingdom
Stanwell Road Surgery
🇬🇧Ashford, Middlesex, United Kingdom
The Burns Practice
🇬🇧Doncaster, South Yorkshire, United Kingdom
The Medical Centre
🇬🇧East Horsley, Surrey, United Kingdom
The Burngreave Surgery
🇬🇧Sheffield, South Yorkshire, United Kingdom
Sherbourne Medical Centre
🇬🇧Leamington Spa, Warwickshire, United Kingdom
Hathaway Surgery
🇬🇧Chippenham, Wiltshire, United Kingdom
Swindon Medical Research Centre, Abbeymeads Medical
🇬🇧Swindon, Wiltshire, United Kingdom
The Orchard Medical Centre
🇬🇧Bristol, United Kingdom