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Completed

NCT Number: NCT00135031

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

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).

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

The Orchard Medical Centre, Bristol, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bifidobacterium infantis 35624

Drug

Primary outcomes

  1. The primary efficacy variable was the abdominal pain score

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Procter and Gamble

Industry

Collaborators

  • Alimentary Health Ltd

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
First posted
Aug 25, 2005
Registry last updated
Jun 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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