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Preventing Childhood Antibiotic-associated Diarrhea by Prebiotics (WGAAD)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00826137
First Posted: January 21, 2009
Last Update Posted: June 14, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Soroka University Medical Center
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Duration of diarrhea. [ Time Frame: During antibiotic treatment+14 days ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy children with acute infection.

Exclusion Criteria:

  • Hypersensitivity to antibiotics, chronic illness.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Soroka University Medical Center
ClinicalTrials.gov Identifier: NCT00826137     History of Changes
Other Study ID Numbers: Sor472908ctil
First Submitted: December 29, 2008
First Posted: January 21, 2009
Last Update Posted: June 14, 2012
Last Verified: June 2012

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
Antitubercular Agents