Use of Nitazoxanide and Probiotics in Acute Diarrhea Seco... | NCT00683982

Studies
Use of Nitazoxanide and Probiotics in Acute Diarrhea Secondary to Rotavirus

NCT00683982

Sponsor

Centro Pediatrico Albina de Patino

Status

Completed

Last Update Posted

May 26, 2008Estimated

Enrollment

75Actual

Phase

Not Applicable

Conditions

Diarrhea
Rotavirus Infection

Interventions

Nitazoxanide
Probiotic mix preparation
Oral hydration solutions

Countries

Bolivia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
PROT261179B

Status Module

Record Verification Date

May 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2007

Primary Completion Date

May 2008Actual

Completion Date

May 2008Actual

First Submitted Date

May 22, 2008

First Submission Date that Met QC Criteria

May 23, 2008

First Posted Date

May 26, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 23, 2008

Last Update Posted Date

May 26, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	This group will receive oral nitazoxanide preparation	Drug: Nitazoxanide
2	Active Comparator	This group will receive a mix combination of probiotics	Drug: Probiotic mix preparation
3	Placebo Comparator	This is the control group receiving only oral or systemic hydration solutions	Other: Oral hydration solutions

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nitazoxanide	Drug	Nitazoxanide 15mg/Kg/day twice day for 3 days	1	Noxom; Givotan

Measure	Description	Time Frame
Duration of diarrhea		Hours

Measure	Description	Time Frame
Duration of hospitalization		hours

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

28 Days

Maximum Age

24 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carlos N Teran, M.D	Centro Pediatrico Albina Patiño	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centro Pediatrico Albina Patiño		Cochabamba	Cochabamba	591	Bolivia

Condition Browse Module

MeSH Terms

ID	Term
D003967	Diarrhea
D012400	Rotavirus Infections

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D012088	Reoviridae Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C041747	nitazoxanide
D019936	Probiotics

Ancestor Terms

ID	Term
D019587	Dietary Supplements
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided