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

Procter and Gamble362 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

362

Conditions

Irritable Bowel Syndrome

Interventions

Bifidobacterium infantis 35624DRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (20)

The Orchard Medical Centre

Bristol, Bristol, United Kingdom

Outcomes

Primary Outcomes

The primary efficacy variable was the abdominal pain score

Secondary Outcomes

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

Data from ClinicalTrials.gov

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