Vetal Laban Intervention Trial Assessing Bowel Symptoms (KF_2013)

This study is not yet open for participant recruitment.
Verified June 2013 by Danisco
Sponsor:
Collaborators:
Almarai
Clinart
Information provided by (Responsible Party):
Danisco
ClinicalTrials.gov Identifier:
NCT01887483
First received: May 27, 2013
Last updated: October 21, 2013
Last verified: June 2013
  Purpose

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).


Condition Intervention Phase
Irritable Bowel Syndrome
Dietary Supplement: Vetal Laban active
Dietary Supplement: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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

Resource links provided by NLM:


Further study details as provided by Danisco:

Primary Outcome Measures:
  • change in functional bowel symptoms [ Time Frame: week 0, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
    Validated questionnaire


Secondary Outcome Measures:
  • change in adequate relief of bowel symptoms [ Time Frame: weekly from week 4 to week 12 ] [ Designated as safety issue: No ]
    Weekly question

  • change in stool defecation frequency [ Time Frame: week 0, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
    Validated scale

  • change in stool microbiota [ Time Frame: week 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
    molecular analyses

  • change in prevalence of adverse events [ Time Frame: continuous from week 0 to 16 ] [ Designated as safety issue: Yes ]
    Recording of adverse and serious adverse events

  • change in stool consistency [ Time Frame: week 0, 4, 8, 12 and 16 ] [ Designated as safety issue: No ]
    Validated scale


Estimated Enrollment: 230
Study Start Date: November 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Vetal Laban active
Vetal Laban with L. acidophilus
Dietary Supplement: Vetal Laban active
Dairy product with probiotic
Other Name: Vetal Laban, Lactobacillus acidophilus
Placebo Comparator: Placebo
Vetal Laban -like product without L. acidophilus
Dietary Supplement: Placebo
Dairy product without probiotic
Other Name: Vetal Laban-like product without L. acidophilus

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01887483

Contacts
Contact: Shada Sayegh, MHSc, CCRA 443 70 55 1 ext 971(0) research@clinart.net

Sponsors and Collaborators
Danisco
Almarai
Clinart
Investigators
Principal Investigator: ABED AL LEHIBI, MD King Fahad Medical City, Riyadh, Kingdom of Saudi Arabia
Principal Investigator: Abdullah Aljahdaly, MD King Abdul Aziz Medical City for National Guard - Riyadh K.S.A.
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
  More Information

No publications provided

Responsible Party: Danisco
ClinicalTrials.gov Identifier: NCT01887483     History of Changes
Other Study ID Numbers: KF_2013
Study First Received: May 27, 2013
Last Updated: October 21, 2013
Health Authority: Saudi Arabia: Saudi Food & Drug Authority

Keywords provided by Danisco:
IBS
bowel function
probiotic

Additional relevant MeSH terms:
Irritable Bowel Syndrome
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 16, 2014