The purpose of this study was to determine the dose-ranging efficacy and safety profile of encapsulated Bifidobacteria infantis 35624 in female subjects with Irritable Bowel Syndrome (IBS)

Condition	Intervention	Phase
Irritable Bowel Syndrome	Drug: Bifidobacterium infantis 35624	Phase III

Further Study Details: 

Primary Outcomes: The primary efficacy variable was the abdominal pain score
Secondary Outcomes: 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.
Expected Total Enrollment:  362

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 randomdized 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.

Ages Eligible for Study:  18 Years   -   65 Years,  Genders Eligible for Study:  Female

Criteria

Inclusion Criteria:

Meet Rome II criteria for the diagnosis of IBS. Refrain from using probiotic supplements during the trial

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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) (23); including major depresssion, 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

United Kingdom
      The Orchard Medical Centre, Bristol,  BS15 2NJ,  United Kingdom
United Kingdom, Cambridgeshire
      The Staploe Medical Centre, Soham,  Cambridgeshire,  CB7 5JD,  United Kingdom
      Yaxley Group Practice, The Health Centre, Peterborough,  Cambridgeshire,  PE7 3JL,  United Kingdom
      Wansford Surgery, Wansford,  Cambridgeshire,  PE8 6PL,  United Kingdom
United Kingdom, County Antrim
      Old School Surgery, Greenisland,  County Antrim,  BT38 8TP,  United Kingdom
United Kingdom, County Down
      Springhill Surgery, Bangor,  County Down,  BT19 1PP,  United Kingdom
      Downpatrick Health Centre, Downpatrick,  County Down,  BT30 6HY,  United Kingdom
United Kingdom, East Sussex
      Little Common Surgery, Bexhill-on-Sea,  East Sussex,  TN39 5JB,  United Kingdom
      Sea Road Surgery, Bexhill-on-Sea,  East Sussex,  TN40 1JJ,  United Kingdom
United Kingdom, Fife
      Valleyfield Health Centre, High Valleyfield,  Fife,  KY 12 8SJ,  United Kingdom
United Kingdom, Middlesex
      Stanwell Road Surgery, Ashford,  Middlesex,  TW18 1SL,  United Kingdom
      Belmont Health Centre, Harrow,  Middlesex,  HA3 7LT,  United Kingdom
United Kingdom, Somerset
      The Frome Medical Practice, Frome,  Somerset,  BA11 1EZ,  United Kingdom
United Kingdom, South Yorkshire
      The Burns Practice, Doncaster,  South Yorkshire,  DN1 2EG,  United Kingdom
      The Burngreave Surgery, Sheffield,  South Yorkshire,  S3 9DA,  United Kingdom
United Kingdom, Surrey
      The Medical Centre, East Horsley,  Surrey,  KT 24 6QT,  United Kingdom
United Kingdom, Wales
      The Penylan Surgery, Cardiff,  Wales,  CF23 5SY,  United Kingdom
United Kingdom, Warwickshire
      Sherbourne Medical Centre, Leamington Spa,  Warwickshire,  CV32 4RA,  United Kingdom
United Kingdom, Wiltshire
      Hathaway Surgery, Chippenham,  Wiltshire,  SN15 1HP,  United Kingdom
      Swindon Medical Research Centre, Abbeymeads Medical, Swindon,  Wiltshire,  SN25 4YZ,  United Kingdom

Study chairs or principal investigators

Peter J. Whorwell, M.D.,  Principal Investigator,  Department of Medicine, Education and Research Centre, Wythenshawe Hospital, Manchester M23 9LT UK   

Study ID Numbers:  2002089
Last Updated:  August 24, 2005
Record first received:  August 23, 2005
ClinicalTrials.gov Identifier:  NCT00135031
Health Authority: United Kingdom: Department of Health
ClinicalTrials.gov processed this record on 2005-09-13