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Use of Nitazoxanide and Probiotics in Acute Diarrhea Secondary to Rotavirus

NCT ID: NCT00683982

Last Updated: 2008-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2008-05-31

Brief Summary

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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?

Detailed Description

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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

Conditions

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Diarrhea Rotavirus Infection

Keywords

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nitazoxanide Probiotics Diarrhea Rotavirus Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Caregivers

Study Groups

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1

This group will receive oral nitazoxanide preparation

Group Type ACTIVE_COMPARATOR

Nitazoxanide

Intervention Type DRUG

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

2

This group will receive a mix combination of probiotics

Group Type ACTIVE_COMPARATOR

Probiotic mix preparation

Intervention Type DRUG

Probiotic preparation 1 gram twice a day for 5 days

3

This is the control group receiving only oral or systemic hydration solutions

Group Type PLACEBO_COMPARATOR

Oral hydration solutions

Intervention Type OTHER

Oral hydration solutions as needed

Interventions

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Nitazoxanide

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

Intervention Type DRUG

Probiotic mix preparation

Probiotic preparation 1 gram twice a day for 5 days

Intervention Type DRUG

Oral hydration solutions

Oral hydration solutions as needed

Intervention Type OTHER

Other Intervention Names

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Noxom; Givotan Probiotic Rehsal 60 2.5% Glucosaline

Eligibility Criteria

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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
Minimum Eligible Age

28 Days

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centro Pediatrico Albina de Patino

OTHER

Sponsor Role lead

Responsible Party

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Centro Pediatrico Albina Patiño

Principal Investigators

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Carlos N Teran, M.D

Role: STUDY_DIRECTOR

Centro Pediatrico Albina Patiño

Locations

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Centro Pediatrico Albina Patiño

Cochabamba, Departamento de Cochabamba, Bolivia

Site Status

Countries

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Bolivia

Other Identifiers

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PROT261179B

Identifier Type: -

Identifier Source: secondary_id

PROT261179

Identifier Type: -

Identifier Source: org_study_id