Preventing Childhood Antibiotic-Associated Diarrhea by Prebiotics - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

December 29, 2008

Last Updated Date

January 20, 2009

Start Date ^†

December 2008

Current Primary Outcome Measures ^†

Prevention of diarrhea. [ Time Frame: During antibiotic treatment+14 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00826137 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Duration of diarrhea. [ Time Frame: During antibiotic treatment+14 days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Preventing Childhood Antibiotic-Associated Diarrhea by Prebiotics

Official Title ^†

Prebiotics in the Prevention of Antibiotic-Associated Diarrhea in Children

Brief Summary

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

Detailed Description

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

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^†

Antibiotic-Associated Diarrhea

Intervention ^†

Dietary Supplement: Inulin and fructo-oligosaccharides.
Dietary Supplement: Placebo

Study Arms / Comparison Groups

Experimental: Treated with prebiotics.
Placebo Comparator: Placebo treated.

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Estimated Enrollment ^†

200

Estimated Completion Date

July 2010

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion Criteria:

Healthy children with acute infection.

Exclusion Criteria:

Hypersensitivity to antibiotics, chronic illness.

Gender

Both

Ages

6 Months to 14 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Israel

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00826137

Responsible Party

Zvi Weizman, MD, Soroka Medical Center

Secondary IDs ^††

Study Sponsor ^†

Soroka University Medical Center

Collaborators ^††

Investigators ^†

Principal Investigator:

Zvi Weizman, MD

Soroka Medical Center

Information Provided By

Soroka University Medical Center

Verification Date

January 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.