Use of Nitazoxanide and Probiotics in Acute Diarrhea Secondary to Rotavirus

This study has been completed.
Sponsor:
Information provided by:
Centro Pediatrico Albina de Patino
ClinicalTrials.gov Identifier:
NCT00683982
First received: May 22, 2008
Last updated: May 23, 2008
Last verified: May 2008

May 22, 2008
May 23, 2008
August 2007
May 2008   (final data collection date for primary outcome measure)
Duration of diarrhea [ Time Frame: Hours ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00683982 on ClinicalTrials.gov Archive Site
Duration of hospitalization [ Time Frame: hours ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Use of Nitazoxanide and Probiotics in Acute Diarrhea Secondary to Rotavirus
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?

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
  • Diarrhea
  • Rotavirus Infection
  • Drug: Nitazoxanide
    Nitazoxanide 15mg/Kg/day twice day for 3 days
    Other Name: Noxom; Givotan
  • Drug: Probiotic mix preparation
    Probiotic preparation 1 gram twice a day for 5 days
    Other Name: Probiotic
  • Other: Oral hydration solutions
    Oral hydration solutions as needed
    Other Names:
    • Rehsal 60
    • 2.5% Glucosaline
  • Active Comparator: 1
    This group will receive oral nitazoxanide preparation
    Intervention: Drug: Nitazoxanide
  • Active Comparator: 2
    This group will receive a mix combination of probiotics
    Intervention: Drug: Probiotic mix preparation
  • Placebo Comparator: 3
    This is the control group receiving only oral or systemic hydration solutions
    Intervention: Other: Oral hydration solutions
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
75
May 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
up to 24 Months
No
Contact information is only displayed when the study is recruiting subjects
Bolivia
 
NCT00683982
PROT261179, PROT261179B
No
Carlos Teran Escalera/Jefe de Comite de Investigacion, Centro Pediatrico Albina Patiño
Centro Pediatrico Albina de Patino
Not Provided
Study Director: Carlos N Teran, M.D Centro Pediatrico Albina Patiño
Centro Pediatrico Albina de Patino
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP