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Completed

NCT Number: NCT00826137

Preventing Childhood Antibiotic-associated Diarrhea by Prebiotics

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

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Key information

Conditions

Antibiotic-associated Diarrhea

Age range

6 month–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Soroka Medical Center

Beersheba, 84101, Israel

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy children with acute infection.

Exclusion criteria

  • Hypersensitivity to antibiotics, chronic illness.

Treatment and study plan

Inulin and fructo-oligosaccharides.

Dietary Supplement

Supplement during antibiotic treatment+14 days.

Other names: Placebo is base powder of product with no oligosaccharides.

Placebo

Dietary Supplement

Placebo is base powder of product with no oligosaccharides.

Primary outcomes

  1. Prevention of diarrhea.

    Time frame: During antibiotic treatment+14 days

Secondary outcomes

  1. Duration of diarrhea.

    Time frame: During antibiotic treatment+14 days

Sponsors and collaborators

Lead sponsor

Soroka University Medical Center

Other

Registry information

Official study title

Prebiotics in the Prevention of Antibiotic-associated Diarrhea in Children

Acronym: WGAAD

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Jan 21, 2009
Registry last updated
Jun 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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