Vetal Laban Intervention Trial Assessing Bowel Symptoms (KF_2013)

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

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).

Study Overview

• Status: Terminated
• Conditions: Irritable Bowel Syndrome
• Intervention / Treatment: Dietary supplement: Vetal Laban active; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 4

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia
    • King Khalid University Hospital
  • Riyadh, Saudi Arabia
    • King Fahd Medical City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Vetal Laban active; Vetal Laban with L. acidophilus	Dietary supplement: Vetal Laban active; Dairy product with probiotic; Other Names: Vetal Laban, Lactobacillus acidophilus
PLACEBO_COMPARATOR: Placebo; Vetal Laban -like product without L. acidophilus	Dietary supplement: Placebo; Dairy product without probiotic; Other Names: Vetal Laban-like product without L. acidophilus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in functional bowel symptoms	Validated questionnaire	week 0, 4, 8, 12 and 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in adequate relief of bowel symptoms	Weekly question	weekly from week 4 to week 12
change in stool defecation frequency	Validated scale	week 0, 4, 8, 12 and 16
change in stool microbiota	molecular analyses	week 4, 8, 12 and 16
change in prevalence of adverse events	Recording of adverse and serious adverse events	continuous from week 0 to 16
change in stool consistency	Validated scale	week 0, 4, 8, 12 and 16

Collaborators and Investigators

• Sponsor: Danisco
• Collaborators: Almarai; Clinart International
• Investigators: Principal Investigator: Abdullah Aljahdali, MD, King Abdulaziz National Guard Hospital, Riyadh, Kingdom of Saudi Arabia; Study Chair: Arthur C Ouwehand, PhD, Danisco Sweeteners Ltd.; Study Director: Anna H Lyra, PhD, Danisco Sweeteners Ltd.; Study Director: Suzanne Alodaib, MSc, Almarai Company, Saudi Arabia; Principal Investigator: Abed Allehibi, Dr, King Fahd Medical City; Principal Investigator: Othman Al-Harbi, Dr, King Khalid University Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): December 1, 2015

Study Registration Dates

• First Submitted: May 27, 2013
• First Submitted That Met QC Criteria: June 26, 2013
• First Posted (ESTIMATE): June 27, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): December 22, 2015
• Last Update Submitted That Met QC Criteria: December 21, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: IBS; probiotic; bowel function
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Irritable Bowel Syndrome
• Other Study ID Numbers: KF_2013