Use of Nitazoxanide and Probiotics in Acute Diarrhea Secondary to Rotavirus

Centro Pediatrico Albina de Patino75 enrolled

Overview

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?

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Diarrhea Rotavirus Infection

Interventions

NitazoxanideDRUG

Nitazoxanide 15mg/Kg/day twice day for 3 days

Probiotic mix preparationDRUG

Probiotic preparation 1 gram twice a day for 5 days

Oral hydration solutionsOTHER

Oral hydration solutions as needed

Eligibility

Sex: ALLMin age: 28 DaysMax age: 24 Months

Medical Language ↔ Plain English

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 (1)

Centro Pediatrico Albina Patiño

Cochabamba, Departamento de Cochabamba, Bolivia

Outcomes

Primary Outcomes

Duration of diarrhea

Time frame: Hours

Secondary Outcomes

Duration of hospitalization

Time frame: hours

Data from ClinicalTrials.gov

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