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

Last updated: June 14, 2011
Sponsor: Procter and Gamble
Overall Status: Completed

Phase

3

Condition

Lactose Intolerance

Colic

Gastrointestinal Diseases And Disorders

Treatment

N/A

Clinical Study ID

NCT00135031
2002089
  • Ages 18-65
  • Female

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Meet Rome II criteria for the diagnosis of IBS

  • Refrain from using probiotic supplements during the trial

Exclusion

Exclusion Criteria:

  • Organic diseases, including inflammatory bowel disease, and significant systemicdiseases

  • Subjects over 55 years of age that had not had a sigmoidoscopy or colonoscopyperformed 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 orappendectomy

Study Design

Total Participants: 362
Study Start date:
January 01, 2004
Estimated Completion Date:
September 30, 2004

Study 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.

Connect with a study center

  • Yaxley Group Practice, The Health Centre

    Peterborough, Cambridgeshire PE7 3JL
    United Kingdom

    Site Not Available

  • The Staploe Medical Centre

    Soham, Cambridgeshire CB7 5JD
    United Kingdom

    Site Not Available

  • Wansford Surgery

    Wansford, Cambridgeshire PE8 6PL
    United Kingdom

    Site Not Available

  • Old School Surgery

    Greenisland, County Antrim BT38 8TP
    United Kingdom

    Site Not Available

  • Springhill Surgery

    Bangor, County Down BT19 1PP
    United Kingdom

    Site Not Available

  • Downpatrick Health Centre

    Downpatrick, County Down BT30 6HY
    United Kingdom

    Site Not Available

  • Little Common Surgery

    Bexhill-on-Sea, East Sussex TN39 5JB
    United Kingdom

    Site Not Available

  • Sea Road Surgery

    Bexhill-on-Sea, East Sussex TN40 1JJ
    United Kingdom

    Site Not Available

  • Valleyfield Health Centre

    High Valleyfield, Fife KY 12 8SJ
    United Kingdom

    Site Not Available

  • Stanwell Road Surgery

    Ashford, Middlesex TW18 1SL
    United Kingdom

    Site Not Available

  • Belmont Health Centre

    Harrow, Middlesex HA3 7LT
    United Kingdom

    Site Not Available

  • The Frome Medical Practice

    Frome, Somerset BA11 1EZ
    United Kingdom

    Site Not Available

  • The Burns Practice

    Doncaster, South Yorkshire DN1 2EG
    United Kingdom

    Site Not Available

  • The Burngreave Surgery

    Sheffield, South Yorkshire S3 9DA
    United Kingdom

    Site Not Available

  • The Medical Centre

    East Horsley, Surrey KT 24 6QT
    United Kingdom

    Site Not Available

  • The Penylan Surgery

    Cardiff, Wales CF23 5SY
    United Kingdom

    Site Not Available

  • Sherbourne Medical Centre

    Leamington Spa, Warwickshire CV32 4RA
    United Kingdom

    Site Not Available

  • Hathaway Surgery

    Chippenham, Wiltshire SN15 1HP
    United Kingdom

    Site Not Available

  • Swindon Medical Research Centre, Abbeymeads Medical

    Swindon, Wiltshire SN25 4YZ
    United Kingdom

    Site Not Available

  • The Orchard Medical Centre

    Bristol, BS15 2NJ
    United Kingdom

    Site Not Available

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