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NCT00826137 Clinical Trial

Preventing Childhood Antibiotic-associated Diarrhea by Prebiotics

Antibiotic-Associated Diarrhea Clinical Trial

— WGAAD  

Official title:
Prebiotics in the Prevention of Antibiotic-associated Diarrhea in Children

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00826137
Other study ID # Sor472908ctil
Secondary ID
Status Completed
Phase Phase 3
First received December 29, 2008
Last updated June 13, 2012
Start date December 2008
Est. completion date July 2010

Study information
Verified date June 2012
Source Soroka University Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date July 2010
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 6 Months to 14 Years
Eligibility Inclusion Criteria:

- Healthy children with acute infection.

Exclusion Criteria:

- Hypersensitivity to antibiotics, chronic illness.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Inulin and fructo-oligosaccharides.
Supplement during antibiotic treatment+14 days.
• Placebo
Placebo is base powder of product with no oligosaccharides.

Locations
Country Name City State
Israel Soroka Medical Center Beer-Sheva

Sponsors (1)
Lead Sponsor Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevention of diarrhea. During antibiotic treatment+14 days No
Secondary Duration of diarrhea. During antibiotic treatment+14 days No
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