Clinical trial NCT01887483: Vetal Laban Intervention Trial Assessing Bowel Symptoms
Official title: A Double-Blind Placebo-Controlled Randomized Clinical Trial Assessing the Effect of 2 Month Consumption of Vetal Laban Including L. Acidophilus on Functional Gastrointestinal Symptoms Among Subjects Fulfilling Rome III Criteria for IBS
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Irritable Bowel Syndrome
Keywords: IBS
bowel function
probiotic
Lead sponsor: Danisco
Sponsor class: INDUSTRY
Collaborators: name: Almarai
name: Clinart International
First posted: 2013-06-27
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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 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

Primary outcomes:
measure: change in functional bowel symptoms
timeFrame: week 0, 4, 8, 12 and 16
Secondary outcomes:
measure: change in adequate relief of bowel symptoms
timeFrame: weekly from week 4 to week 12
measure: change in stool defecation frequency
timeFrame: week 0, 4, 8, 12 and 16
measure: change in stool microbiota
timeFrame: week 4, 8, 12 and 16
measure: change in prevalence of adverse events
timeFrame: continuous from week 0 to 16
measure: change in stool consistency
timeFrame: week 0, 4, 8, 12 and 16
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Fahd Medical City
city: Riyadh
country: Saudi Arabia
facility: King Khalid University Hospital
Study officials:
affiliation: King Abdulaziz National Guard Hospital, Riyadh, Kingdom of Saudi Arabia
name: Abdullah Aljahdali, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Danisco Sweeteners Ltd.
name: Arthur C Ouwehand, PhD
role: STUDY_CHAIR
affiliation: Danisco Sweeteners Ltd.
name: Anna H Lyra, PhD
role: STUDY_DIRECTOR
affiliation: Almarai Company, Saudi Arabia
name: Suzanne Alodaib, MSc
role: STUDY_DIRECTOR
affiliation: King Fahd Medical City
name: Abed Allehibi, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: King Khalid University Hospital
name: Othman Al-Harbi, Dr
role: PRINCIPAL_INVESTIGATOR
References: