Vetal Laban Intervention Trial Assessing Bowel Symptoms

Phase 4

Terminated

• Conditions: Irritable Bowel Syndrome
• Interventions: Dietary Supplement: Vetal Laban active; Dietary Supplement: Placebo

• Registration Number: NCT01887483
• Lead Sponsor: Danisco

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-27
• Study First Submitted QC: 2013-06-26
• Study First Posted: 2013-06-27
• Study Start: 2014-03
• Status Verified: 2015-12
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Last Update Submitted: 2015-12-21
• Last Update Posted: 2015-12-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vetal Laban active	Vetal Laban active	Vetal Laban with L. acidophilus
Placebo	Placebo	Vetal Laban -like product without L. acidophilus

Primary Outcome Measures

Name	Time	Method
change in functional bowel symptoms	week 0, 4, 8, 12 and 16	Validated questionnaire

Secondary Outcome Measures

Name	Time	Method
change in adequate relief of bowel symptoms	weekly from week 4 to week 12	Weekly question
change in stool defecation frequency	week 0, 4, 8, 12 and 16	Validated scale
change in stool microbiota	week 4, 8, 12 and 16	molecular analyses
change in prevalence of adverse events	continuous from week 0 to 16	Recording of adverse and serious adverse events
change in stool consistency	week 0, 4, 8, 12 and 16	Validated scale

Trial Locations

Locations (2)

King Fahd Medical City; 🇸🇦 Riyadh, Saudi Arabia

King Khalid University Hospital; 🇸🇦 Riyadh, Saudi Arabia