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Vetal Laban Intervention Trial Assessing Bowel Symptoms (KF_2013)

This study has been terminated.
(Slow recruitment, high drop-out)
ClinicalTrials.gov Identifier:
First Posted: June 27, 2013
Last Update Posted: December 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Clinart International
Information provided by (Responsible Party):
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]
    Validated questionnaire

Secondary Outcome Measures:
  • change in adequate relief of bowel symptoms [ Time Frame: weekly from week 4 to week 12 ]
    Weekly question

  • change in stool defecation frequency [ Time Frame: week 0, 4, 8, 12 and 16 ]
    Validated scale

  • change in stool microbiota [ Time Frame: week 4, 8, 12 and 16 ]
    molecular analyses

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

  • change in stool consistency [ Time Frame: week 0, 4, 8, 12 and 16 ]
    Validated scale

Enrollment: 62
Study Start Date: March 2014
Study Completion Date: December 2015
Primary Completion Date: December 2015 (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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01887483

Saudi Arabia
King Fahd Medical City
Riyadh, Saudi Arabia
King Khalid University Hospital
Riyadh, Saudi Arabia
Sponsors and Collaborators
Clinart International
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
  More Information

Responsible Party: Danisco
ClinicalTrials.gov Identifier: NCT01887483     History of Changes
Other Study ID Numbers: KF_2013
First Submitted: May 27, 2013
First Posted: June 27, 2013
Last Update Posted: December 22, 2015
Last Verified: December 2015

Keywords provided by Danisco:
bowel function

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