Diarrhea, Rotavirus Infection
Conditions
Keywords
nitazoxanide, Probiotics, Diarrhea, Rotavirus, 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?
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
Interventions
DRUGNitazoxanide
Nitazoxanide 15mg/Kg/day twice day for 3 days
Probiotic preparation 1 gram twice a day for 5 days
OTHEROral hydration solutions
Oral hydration solutions as needed
Sponsors
Centro Pediatrico Albina de Patino
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
28 Days to 24 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of diarrhea | Hours |
Secondary
| Measure | Time frame |
|---|---|
| Duration of hospitalization | hours |
Countries
Bolivia
Outcome results
None listed