Trial | NCT00135031  Report issue

Title

Efficacy of an Encapsulated Probiotic Bifidobacterium Infantis 35624 in Irritable Bowel Syndrome
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Safety and Efficacy Evaluation of Bifidobacterium Infantis 35624 in Female Subjects With Irritable Bowel Syndrome

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    362
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).
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.
Study Started
Jan 31
2004
Primary Completion
Sep 30
2004
Study Completion
Sep 30
2004
Last Update
Jun 15
2011
Estimate

Drug Bifidobacterium infantis 35624

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
No Results Posted