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Vetal Laban Intervention Trial Assessing Bowel Symptoms

NCT ID: NCT01887483

Last Updated: 2015-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2015-12-31

Brief Summary

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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

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Conditions

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Irritable Bowel Syndrome

Keywords

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IBS bowel function probiotic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Vetal Laban active

Vetal Laban with L. acidophilus

Group Type ACTIVE_COMPARATOR

Vetal Laban active

Intervention Type DIETARY_SUPPLEMENT

Dairy product with probiotic

Placebo

Vetal Laban -like product without L. acidophilus

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Dairy product without probiotic

Interventions

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Vetal Laban active

Dairy product with probiotic

Intervention Type DIETARY_SUPPLEMENT

Placebo

Dairy product without probiotic

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Vetal Laban, Lactobacillus acidophilus Vetal Laban-like product without L. acidophilus

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Almarai

UNKNOWN

Sponsor Role collaborator

Clinart International

INDUSTRY

Sponsor Role collaborator

Danisco

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Abdullah Aljahdali, MD

Role: PRINCIPAL_INVESTIGATOR

King Abdulaziz National Guard Hospital, Riyadh, Kingdom of Saudi Arabia

Arthur C Ouwehand, PhD

Role: STUDY_CHAIR

Danisco Sweeteners Ltd.

Anna H Lyra, PhD

Role: STUDY_DIRECTOR

Danisco Sweeteners Ltd.

Suzanne Alodaib, MSc

Role: STUDY_DIRECTOR

Almarai Company, Saudi Arabia

Abed Allehibi, Dr

Role: PRINCIPAL_INVESTIGATOR

King Fahd Medical City

Othman Al-Harbi, Dr

Role: PRINCIPAL_INVESTIGATOR

King Khalid University Hospital

Locations

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King Fahd Medical City

Riyadh, , Saudi Arabia

Site Status

King Khalid University Hospital

Riyadh, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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KF_2013

Identifier Type: -

Identifier Source: org_study_id