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Preventing Childhood Antibiotic-associated Diarrhea by Prebiotics

Prebiotics in the Prevention of Antibiotic-associated Diarrhea in Children

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00826137
Acronym
WGAAD
Enrollment
200
Registered
2009-01-21
Start date
2008-12-31
Completion date
2010-07-31
Last updated
2012-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotic-Associated Diarrhea

Keywords

prebiotics, Antibiotic-associated diarrhea

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.

Interventions

DIETARY_SUPPLEMENTInulin and fructo-oligosaccharides.

Supplement during antibiotic treatment+14 days.

DIETARY_SUPPLEMENTPlacebo

Placebo is base powder of product with no oligosaccharides.

Sponsors

Soroka University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
6 Months to 14 Years
Healthy volunteers
No

Inclusion criteria

* Healthy children with acute infection.

Exclusion criteria

* Hypersensitivity to antibiotics, chronic illness.

Design outcomes

Primary

MeasureTime frame
Prevention of diarrhea.During antibiotic treatment+14 days

Secondary

MeasureTime frame
Duration of diarrhea.During antibiotic treatment+14 days

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026