Vetal Laban Intervention Trial Assessing Bowel Symptoms (KF_2013)

D

Danisco

Status and phase

Terminated
Phase 4

Conditions

Irritable Bowel Syndrome

Treatments

Dietary Supplement: Placebo
Dietary Supplement: Vetal Laban active

Study type

Interventional

Funder types

Industry
Other

Identifiers

NCT01887483
KF_2013

Details and patient eligibility

About

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).

Enrollment

62 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

62 participants in 2 patient groups, including a placebo group

Vetal Laban active
Active Comparator group
Description:
Vetal Laban with L. acidophilus
Treatment:
Dietary Supplement: Vetal Laban active
Placebo
Placebo Comparator group
Description:
Vetal Laban -like product without L. acidophilus
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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