Irritable Bowel Syndrome
Conditions
Brief 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).
Detailed description
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.
Interventions
Sponsors
Alimentary Health Ltd
Procter and Gamble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy variable was the abdominal pain score | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom
Outcome results
None listed