Use of Nitazoxanide and Probiotics in Acute Diarrhea Secondary to Rotavirus

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?

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Care Provider)
  • Study Primary Completion Date: May 2008

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

  • 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

  • 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

Clinical Trial Outcome Measures

Primary Measures

  • Duration of diarrhea
    • Time Frame: Hours

Secondary Measures

  • Duration of hospitalization
    • Time Frame: hours

Participating in This Clinical Trial

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: All

Minimum Age: 28 Days

Maximum Age: 24 Months

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centro Pediatrico Albina de Patino
  • Provider of Information About this Clinical Study
    • Carlos Teran Escalera/Jefe de Comite de Investigacion, Centro Pediatrico Albina Patiño
  • Overall Official(s)
    • Carlos N Teran, M.D, Study Director, Centro Pediatrico Albina Patiño

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