Back to resultsPreventing Childhood Antibiotic-associated Diarrhea by Prebiotics (WGAAD)
Primary Purpose
Antibiotic-Associated Diarrhea
Status
Completed
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Inulin and fructo-oligosaccharides.
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Antibiotic-Associated Diarrhea focused on measuring prebiotics, Antibiotic-associated diarrhea
Eligibility Criteria
Inclusion Criteria:
- Healthy children with acute infection.
Exclusion Criteria:
- Hypersensitivity to antibiotics, chronic illness.
Sites / Locations
- Soroka Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
A
B
Arm Description
Treated with prebiotics.
Placebo treated.
Outcomes
Primary Outcome Measures
Prevention of diarrhea.
Secondary Outcome Measures
Duration of diarrhea.
Full Information
NCT ID
NCT00826137
First Posted
December 29, 2008
Last Updated
June 13, 2012
Sponsor
Soroka University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00826137
Brief Title
Preventing Childhood Antibiotic-associated Diarrhea by Prebiotics
Acronym
WGAAD
Official Title
Prebiotics in the Prevention of Antibiotic-associated Diarrhea in Children
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Soroka University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antibiotic-Associated Diarrhea
Keywords
prebiotics, Antibiotic-associated diarrhea
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Treated with prebiotics.
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Placebo treated.
Intervention Type
Dietary Supplement
Intervention Name(s)
Inulin and fructo-oligosaccharides.
Other Intervention Name(s)
Placebo is base powder of product with no oligosaccharides.
Intervention Description
Supplement during antibiotic treatment+14 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo is base powder of product with no oligosaccharides.
Primary Outcome Measure Information:
Title
Prevention of diarrhea.
Time Frame
During antibiotic treatment+14 days
Secondary Outcome Measure Information:
Title
Duration of diarrhea.
Time Frame
During antibiotic treatment+14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Healthy children with acute infection.
Exclusion Criteria:
Hypersensitivity to antibiotics, chronic illness.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zvi Weizman, MD
Organizational Affiliation
Soroka University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soroka Medical Center
City
Beer-Sheva
ZIP/Postal Code
84101
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Preventing Childhood Antibiotic-associated Diarrhea by Prebiotics
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