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

Sponsored by Procter and Gamble

About this trial

Last updated 14 years ago

Study ID

2002089

Status

Completed

Type

Interventional

Phase

Phase 3

Placebo

No

Accepting

18-75 Years
18 to 65 Years
Female
Female

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 21 years ago

What is this trial about?

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).

What are the participation requirements?

Yes

Inclusion Criteria

- Meet Rome II criteria for the diagnosis of IBS

- Refrain from using probiotic supplements during the trial

No

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

Locations

Location

Status