Use of Nitazoxanide and Probiotics in Acute Diarrhea Secondary to Rotavirus
This study has been completed.
Sponsor:
Centro Pediatrico Albina de Patino
Information provided by:
Centro Pediatrico Albina de Patino
ClinicalTrials.gov Identifier:
NCT00683982
First received: May 22, 2008
Last updated: May 23, 2008
Last verified: May 2008
| Tracking Information | |||||
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| First Received Date ICMJE | May 22, 2008 | ||||
| Last Updated Date | May 23, 2008 | ||||
| Start Date ICMJE | August 2007 | ||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Duration of diarrhea [ Time Frame: Hours ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00683982 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Duration of hospitalization [ Time Frame: hours ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Use of Nitazoxanide and Probiotics in Acute Diarrhea Secondary to Rotavirus | ||||
| Official Title ICMJE | Nitazoxanide vs Probiotics in the Treatment of Acute Rotavirus Diarrhea in Children: A Randomized Single Blind Controlled Trial in Bolivian Children | ||||
| Brief Summary | Nitazoxanide has proved an cytoprotective effect against rotavirus infection. How it could be clinically important in time of hospitalization and reduction of duration of diarrhea secondary to rotavirus? |
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| Detailed Description | Nitazoxanide has demonstrated a cytoprotective effect against rotavirus, reducing duration time of diarrhea in comparison to placebo in previous studies. In the current study, based in those results, we design a randomized single-blind controlled trial, in order to asses the effectiveness of nitazoxanide and probiotics in comparison with a control group |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Caregiver) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 75 | ||||
| Completion Date | May 2008 | ||||
| Primary Completion Date | May 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | up to 24 Months | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Bolivia | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00683982 | ||||
| Other Study ID Numbers ICMJE | PROT261179, PROT261179B | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Carlos Teran Escalera/Jefe de Comite de Investigacion, Centro Pediatrico Albina Patiño | ||||
| Study Sponsor ICMJE | Centro Pediatrico Albina de Patino | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Centro Pediatrico Albina de Patino | ||||
| Verification Date | May 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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