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

• Status: Completed
• Trial end date: 2004-09-01
• Target enrollment: 0
• Participant gender: Female

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Procter and Gamble
• Collaborator: Alimentary Health Ltd

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