Status:
TERMINATED
Vetal Laban Intervention Trial Assessing Bowel Symptoms
Lead Sponsor:
Danisco
Collaborating Sponsors:
Almarai
Clinart International
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT01887483
Start Date
March 1 2014
End Date
December 1 2015
Last Update
December 22 2015
Active Locations (2)
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1
King Fahd Medical City
Riyadh, Saudi Arabia
2
King Khalid University Hospital
Riyadh, Saudi Arabia