Preventing Childhood Antibiotic-associated Diarrhea by Prebiotics

Phase 3

Completed

• Conditions: Antibiotic-Associated Diarrhea
• Interventions: Dietary Supplement: Inulin and fructo-oligosaccharides.; Dietary Supplement: Placebo

• Registration Number: NCT00826137
• Lead Sponsor: Soroka University Medical Center

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 Timeline

• Study Start: 2008-12
• Study First Submitted: 2008-12-29
• Study First Submitted QC: 2009-01-20
• Study First Posted: 2009-01-21
• Primary Completion: 2009-12
• Study Completion: 2010-07
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-13
• Last Update Posted: 2012-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Healthy children with acute infection.

Exclusion Criteria

• Hypersensitivity to antibiotics, chronic illness.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Inulin and fructo-oligosaccharides.	Treated with prebiotics.
B	Placebo	Placebo treated.

Primary Outcome Measures

Name	Time	Method
Prevention of diarrhea.	During antibiotic treatment+14 days

Secondary Outcome Measures

Name	Time	Method
Duration of diarrhea.	During antibiotic treatment+14 days

Trial Locations

Locations (1)

Soroka Medical Center; 🇮🇱 Beer-Sheva, Israel