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NCT Number: NCT00683982

Use of Nitazoxanide and Probiotics in Acute Diarrhea Secondary to Rotavirus

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?

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Key information

Conditions

Diarrhea Infections Pathological Conditions, Signs and Symptoms RNA Virus Infections Reoviridae Infections Rotavirus Infection Rotavirus Infections Signs and Symptoms Signs and Symptoms, Digestive Virus Diseases

Age range

28 day–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Pediatrico Albina Patiño

Cochabamba, 591, Bolivia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nitazoxanide

Drug

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

Other names: Noxom; Givotan

Probiotic mix preparation

Drug

Probiotic preparation 1 gram twice a day for 5 days

Other names: Probiotic

Oral hydration solutions

Other

Oral hydration solutions as needed

Other names: Rehsal 60, 2.5% Glucosaline

Primary outcomes

  1. Duration of diarrhea

    Time frame: Hours

Secondary outcomes

  1. Duration of hospitalization

    Time frame: hours

Sponsors and collaborators

Lead sponsor

Centro Pediatrico Albina de Patino

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 26, 2008
Registry last updated
May 26, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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