Use of Nitazoxanide and Probiotics in Acute Diarrhea Secondary to Rotavirus

May 23, 2008 updated by: Centro Pediatrico Albina de Patino

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bolivia
      • Cochabamba, Bolivia, 591
        • Centro Pediatrico Albina Patino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 weeks to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
This group will receive oral nitazoxanide preparation
Drug: Nitazoxanide
Nitazoxanide 15mg/Kg/day twice day for 3 days
Other Names:
  • Noxom; Givotan
Active Comparator: 2
This group will receive a mix combination of probiotics
Drug: Probiotic mix preparation
Probiotic preparation 1 gram twice a day for 5 days
Other Names:
  • Probiotic
Placebo Comparator: 3
This is the control group receiving only oral or systemic hydration solutions
Other: Oral hydration solutions
Oral hydration solutions as needed
Other Names:
  • Rehsal 60
  • 2.5% Glucosaline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of diarrhea
Time Frame: Hours
Hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of hospitalization
Time Frame: hours
hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Pediatrico Albina de Patino

Investigators

  • Study Director: Carlos N Teran, M.D, Centro Pediatrico Albina Patino

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

May 22, 2008

First Submitted That Met QC Criteria

May 23, 2008

First Posted (Estimate)

May 26, 2008

Study Record Updates

Last Update Posted (Estimate)

May 26, 2008

Last Update Submitted That Met QC Criteria

May 23, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROT261179
  • PROT261179B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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