Preventing Childhood Antibiotic-associated Diarrhea by Prebiotics (WGAAD)

June 13, 2012 updated by: Soroka University Medical Center

Prebiotics in the Prevention of Antibiotic-associated Diarrhea in Children

Prospective randomized double-blind study on the effect of prebiotics (inulin and fructo-oligosaccharides) in the prevention of antibiotic-associated diarrhea in children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Group will get either the product or placebo blindly throughout antibiotic treatment with additional 14 days.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Beer-Sheva, Israel, 84101
        • Soroka Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy children with acute infection.

Exclusion Criteria:

  • Hypersensitivity to antibiotics, chronic illness.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Treated with prebiotics.
Dietary supplement: Inulin and fructo-oligosaccharides.
Supplement during antibiotic treatment+14 days.
Other Names:
  • Placebo is base powder of product with no oligosaccharides.
Placebo Comparator: B
Placebo treated.
Dietary supplement: Placebo
Placebo is base powder of product with no oligosaccharides.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevention of diarrhea.
Time Frame: During antibiotic treatment+14 days
During antibiotic treatment+14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of diarrhea.
Time Frame: During antibiotic treatment+14 days
During antibiotic treatment+14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soroka University Medical Center

Investigators

  • Principal Investigator: Zvi Weizman, MD, Soroka University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

December 29, 2008

First Submitted That Met QC Criteria

January 20, 2009

First Posted (Estimate)

January 21, 2009

Study Record Updates

Last Update Posted (Estimate)

June 14, 2012

Last Update Submitted That Met QC Criteria

June 13, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sor472908ctil

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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