Official Title: “Nitazoxanide vs Probiotics in the Treatment of Acute Rotavirus Diarrhea in Children: A Randomized Single Blind Controlled Trial in Bolivian Children”

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?

Study Type: Interventional

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

Study Primary Completion Date: May 2008

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

Intervention(s) in this Clinical Trial

• Drug: Nitazoxanide
  • Nitazoxanide 15mg/Kg/day twice day for 3 days
• Drug: Probiotic mix preparation
  • Probiotic preparation 1 gram twice a day for 5 days
• Other: Oral hydration solutions
  • Oral hydration solutions as needed

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • This group will receive oral nitazoxanide preparation
• Active Comparator: 2
  • This group will receive a mix combination of probiotics
• Placebo Comparator: 3
  • This is the control group receiving only oral or systemic hydration solutions

Primary Measures

• Duration of diarrhea
  • Time Frame: Hours
    Safety Issue?: Yes

Secondary Measures

• Duration of hospitalization
  • Time Frame: hours
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: 24 Months

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Centro Pediatrico Albina de Patino

Overall Clinical Trial Officials and Contacts

Carlos N Teran, M.D Study Director Centro Pediatrico Albina Patiño  

Information obtained from ClinicalTrials.gov on August 21, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00683982

Study ID Number: PROT261179

ClinicalTrials.gov Identifier: NCT00683982

Health Authority: Bolivia: Ministry of Health