Preventing Childhood Antibiotic-associated Diarrhea by Prebiotics (WGAAD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00826137
First received: December 29, 2008
Last updated: June 13, 2012
Last verified: June 2012
  Purpose

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


Condition Intervention Phase
Antibiotic-Associated Diarrhea
Dietary Supplement: Inulin and fructo-oligosaccharides.
Dietary Supplement: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prebiotics in the Prevention of Antibiotic-associated Diarrhea in Children

Resource links provided by NLM:


Further study details as provided by Soroka University Medical Center:

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

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

Enrollment: 200
Study Start Date: December 2008
Study Completion Date: July 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Treated with prebiotics.
Dietary Supplement: Inulin and fructo-oligosaccharides.
Supplement during antibiotic treatment+14 days.
Other Name: Placebo is base powder of product with no oligosaccharides.
Placebo Comparator: B
Placebo treated.
Dietary Supplement: Placebo
Placebo is base powder of product with no oligosaccharides.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   6 Months to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy children with acute infection.

Exclusion Criteria:

  • Hypersensitivity to antibiotics, chronic illness.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00826137

Locations
Israel
Soroka Medical Center
Beer-Sheva, Israel, 84101
Sponsors and Collaborators
Soroka University Medical Center
Investigators
Principal Investigator: Zvi Weizman, MD Soroka Medical Center
  More Information

No publications provided

Responsible Party: Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT00826137     History of Changes
Other Study ID Numbers: Sor472908ctil
Study First Received: December 29, 2008
Last Updated: June 13, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Soroka University Medical Center:
prebiotics
Antibiotic-associated diarrhea

Additional relevant MeSH terms:
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on April 14, 2014