Back to results

Use of Nitazoxanide and Probiotics in Acute Diarrhea Secondary to Rotavirus

Primary Purpose

Diarrhea, Rotavirus Infection

Status

Completed

Phase

Not Applicable

Locations

Bolivia

Study Type

Interventional

Intervention

Nitazoxanide

Probiotic mix preparation

Oral hydration solutions

About this trial

This is an interventional treatment trial for Diarrhea focused on measuring nitazoxanide, Probiotics, Diarrhea, Rotavirus, Children

Eligibility Criteria

28 Days - 24 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Centro Pediatrico Albina Patiño

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

This group will receive oral nitazoxanide preparation

This group will receive a mix combination of probiotics

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

Outcomes

Primary Outcome Measures

Duration of diarrhea

Secondary Outcome Measures

Duration of hospitalization

Full Information

NCT ID

NCT00683982

First Posted

May 22, 2008

Last Updated

May 23, 2008

Sponsor

Centro Pediatrico Albina de Patino

1. Study Identification

Unique Protocol Identification Number

NCT00683982

Brief Title

Use of Nitazoxanide and Probiotics in Acute Diarrhea Secondary to Rotavirus

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2008

Overall Recruitment Status

Completed

Study Start Date

August 2007 (undefined)

Primary Completion Date

May 2008 (Actual)

Study Completion Date

May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Centro Pediatrico Albina de Patino

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diarrhea, Rotavirus Infection

Keywords

nitazoxanide, Probiotics, Diarrhea, Rotavirus, Children

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Care Provider

Allocation

Randomized

Enrollment

75 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

This group will receive oral nitazoxanide preparation

Arm Title

Arm Type

Active Comparator

Arm Description

This group will receive a mix combination of probiotics

Arm Title

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Nitazoxanide

Other Intervention Name(s)

Noxom; Givotan

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Probiotic mix preparation

Other Intervention Name(s)

Probiotic

Intervention Description

Probiotic preparation 1 gram twice a day for 5 days

Intervention Type

Other

Intervention Name(s)

Oral hydration solutions

Other Intervention Name(s)

Rehsal 60, 2.5% Glucosaline

Intervention Description

Oral hydration solutions as needed

Primary Outcome Measure Information:

Title

Duration of diarrhea

Time Frame

Hours

Secondary Outcome Measure Information:

Title

Duration of hospitalization

Time Frame

hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

28 Days

Maximum Age & Unit of Time

24 Months

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carlos N Teran, M.D

Organizational Affiliation

Centro Pediatrico Albina Patiño

Official's Role

Study Director

Facility Information:

Facility Name

Centro Pediatrico Albina Patiño

City

Cochabamba

ZIP/Postal Code

591

Country

Bolivia

12. IPD Sharing Statement

Learn more about this trial

Use of Nitazoxanide and Probiotics in Acute Diarrhea Secondary to Rotavirus

We'll reach out to this number within 24 hrs