Trial | NCT01887483  Report issue

Title

Vetal Laban Intervention Trial Assessing Bowel Symptoms
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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    62
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 Started
Mar 31
2014
Primary Completion
Dec 31
2015
Study Completion
Dec 31
2015
Last Update
Dec 22
2015
Estimate

Dietary Supplement Vetal Laban active

Dairy product with probiotic

  • Other names: Vetal Laban, Lactobacillus acidophilus

Dietary Supplement Placebo

Dairy product without probiotic

  • Other names: Vetal Laban-like product without L. acidophilus

Vetal Laban active Active Comparator

Vetal Laban with L. acidophilus

Placebo Placebo Comparator

Vetal Laban -like product without L. acidophilus

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
No Results Posted