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Vetal Laban Intervention Trial Assessing Bowel Symptoms (KF_2013)

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ClinicalTrials.gov Identifier: NCT01887483
Recruitment Status : Terminated (Slow recruitment, high drop-out)
First Posted : June 27, 2013
Last Update Posted : December 22, 2015
Clinart International
Information provided by (Responsible Party):

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).

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Dietary Supplement: Vetal Laban active Dietary Supplement: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
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
Study Start Date : March 2014
Primary Completion Date : December 2015
Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. change in functional bowel symptoms [ Time Frame: week 0, 4, 8, 12 and 16 ]
    Validated questionnaire

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

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

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

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

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

Information from the National Library of Medicine

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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

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

Responsible Party: Danisco
ClinicalTrials.gov Identifier: NCT01887483     History of Changes
Other Study ID Numbers: KF_2013
First Posted: June 27, 2013    Key Record Dates
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