Irritable Bowel Syndrome
Conditions
Keywords
IBS, bowel function, probiotic
Brief summary
A two month intervention trial assessing the effect of Vetal Laban containing L. acidophilus on enhancing functional bowel wellbeing among subjects with irritable bowel syndrome (IBS).
Interventions
DIETARY_SUPPLEMENTVetal Laban active
Dairy product with probiotic
DIETARY_SUPPLEMENTPlacebo
Dairy product without probiotic
Sponsors
Almarai
Clinart International
Danisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Males and females aged 18 to 65 years * Subjects fulfilling Rome III criteria for IBS * Sufficient health and orientation for participating in the trial * Obtained his/her informed consent after verbal and written information. * Have a high probability for compliance with and completion of the study. * Body Mass Index (BMI) between 19 and 35.
Exclusion criteria
* Diagnosed or suspected organic gastrointestinal disease (i.e. colitis, Crohn's disease, celiac disease, major bowel surgery, recurrent diverticulitis) or severely impaired general health including cancer and cancer therapy. * Lactose intolerance * Unwillingness to refrain from probiotic use during the trial * Use of antibiotics within the 3 preceding months prior to recruitment * Pregnant, planning pregnancy or lactating * Expected major lifestyle changes related to nutrition, exercise, travelling etc. * Participation in a clinical trial with an investigational product or drug within 3 months prior to screening. * Substance abuse * Subjects unable to read and understand the questionnaires
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in functional bowel symptoms | week 0, 4, 8, 12 and 16 | Validated questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in adequate relief of bowel symptoms | weekly from week 4 to week 12 | Weekly question |
| change in stool defecation frequency | week 0, 4, 8, 12 and 16 | Validated scale |
| change in stool microbiota | week 4, 8, 12 and 16 | molecular analyses |
| change in prevalence of adverse events | continuous from week 0 to 16 | Recording of adverse and serious adverse events |
| change in stool consistency | week 0, 4, 8, 12 and 16 | Validated scale |
Countries
Saudi Arabia
Outcome results
None listed