Use of Nitazoxanide and Probiotics in Acute Diarrhea Secondary to Rotavirus

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

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?

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: Treatment, Randomized, Single Blind (Caregiver), Active Control, Parallel Assignment, Efficacy Study

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

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

Centro Pediatrico Albina Patiño, Cochabamba 591, Bolivia

Starting date: August 2007
Ending date: May 2008
Last updated: May 23, 2008