Use of Nitazoxanide and Probiotics in Acute Diarrhea Secondary to Rotavirus
Information source: Centro Pediatrico Albina de Patino
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diarrhea; Rotavirus Infection
Intervention: Nitazoxanide (Drug); Probiotic mix preparation (Drug); Oral hydration solutions (Other)
Phase: N/A
Status: Completed
Sponsored by: Centro Pediatrico Albina de Patino Official(s) and/or principal investigator(s): Carlos N Teran, M.D, Study Director, Affiliation: Centro Pediatrico Albina Patiño
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?
Clinical Details
Official title: Nitazoxanide vs Probiotics in the Treatment of Acute Rotavirus Diarrhea in Children: A Randomized Single Blind Controlled Trial in Bolivian Children
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment
Primary outcome: Duration of diarrhea
Secondary outcome: Duration of hospitalization
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
Eligibility
Minimum age: N/A.
Maximum age: 24 Months.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Positive stool sample for rotavirus test
Exclusion Criteria:
- Severe malnourishment
- Severe dehydration
- History of diarrhea more than 3 days previous hospitalization
- Use of antibiotics, probiotics or nitazoxanide 3 weeks before admission
- Systemic infections
- Severe chronic disease
- Mixed enteric infections besides rotavirus
Locations and Contacts
Centro Pediatrico Albina Patiño, Cochabamba 591, Bolivia
Additional Information
Starting date: August 2007
Last updated: May 23, 2008
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