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Tracking Information | |||||
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First Received Date † | December 29, 2008 | ||||
Last Updated Date | January 20, 2009 | ||||
Start Date † | December 2008 | ||||
Current Primary Outcome Measures † |
Prevention of diarrhea. [ Time Frame: During antibiotic treatment+14 days ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00826137 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
Duration of diarrhea. [ Time Frame: During antibiotic treatment+14 days ] [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Preventing Childhood Antibiotic-Associated Diarrhea by Prebiotics | ||||
Official Title † | Prebiotics in the Prevention of Antibiotic-Associated Diarrhea in Children | ||||
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. |
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Detailed Description | Group will get either the product or placebo blindly throughout antibiotic treatment with additional 14 days. |
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Study Phase | Phase III | ||||
Study Type † | Interventional | ||||
Study Design † | Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study | ||||
Condition † | Antibiotic-Associated Diarrhea | ||||
Intervention † |
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Study Arms / Comparison Groups |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Active, not recruiting | ||||
Estimated Enrollment † | 200 | ||||
Estimated Completion Date | July 2010 | ||||
Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 6 Months to 14 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | Israel | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00826137 | ||||
Responsible Party | Zvi Weizman, MD, Soroka Medical Center | ||||
Secondary IDs †† | |||||
Study Sponsor † | Soroka University Medical Center | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Soroka University Medical Center | ||||
Verification Date | January 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |