Use of Nitazoxanide and Probiotics in Acute Diarrhea Secondary to Rotavirus - Full Text View

Sponsored by:	Centro Pediatrico Albina de Patino
Information provided by:	Centro Pediatrico Albina de Patino
ClinicalTrials.gov Identifier:	NCT00683982

Purpose

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?

Condition	Intervention
Diarrhea Rotavirus Infection	Drug: Nitazoxanide Drug: Probiotic mix preparation Other: Oral hydration solutions

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Caregiver), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Nitazoxanide vs Probiotics in the Treatment of Acute Rotavirus Diarrhea in Children: A Randomized Single Blind Controlled Trial in Bolivian Children

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea Rotavirus Infections

Drug Information available for: Nitazoxanide

U.S. FDA Resources

Further study details as provided by Centro Pediatrico Albina de Patino:

Primary Outcome Measures:

Duration of diarrhea [ Time Frame: Hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Duration of hospitalization [ Time Frame: hours ] [ Designated as safety issue: Yes ]

Enrollment:	75
Study Start Date:	August 2007
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator This group will receive oral nitazoxanide preparation	Drug: Nitazoxanide Nitazoxanide 15mg/Kg/day twice day for 3 days
2: Active Comparator This group will receive a mix combination of probiotics	Drug: Probiotic mix preparation Probiotic preparation 1 gram twice a day for 5 days
3: Placebo Comparator This is the control group receiving only oral or systemic hydration solutions	Other: Oral hydration solutions Oral hydration solutions as needed

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

Eligibility

Ages Eligible for Study:	up to 24 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00683982

Locations

Bolivia
Centro Pediatrico Albina Patiño
Cochabamba, Bolivia, 591

Sponsors and Collaborators

Centro Pediatrico Albina de Patino

Investigators

Study Director:

Carlos N Teran, M.D

Centro Pediatrico Albina Patiño

More Information

No publications provided

Responsible Party:	Centro Pediatrico Albina Patiño ( Carlos Teran Escalera/Jefe de Comite de Investigacion )
Study ID Numbers:	PROT261179, PROT261179B
Study First Received:	May 22, 2008
Last Updated:	May 23, 2008
ClinicalTrials.gov Identifier:	NCT00683982 History of Changes
Health Authority:	Bolivia: Ministry of Health

Keywords provided by Centro Pediatrico Albina de Patino:

nitazoxanide
Probiotics
Diarrhea
Rotavirus
Children

Study placed in the following topic categories:

Virus Diseases
Anti-Infective Agents
Signs and Symptoms
Diarrhea

Signs and Symptoms, Digestive
Rotavirus Infections
Neoplasm Metastasis
Nitazoxanide

Additional relevant MeSH terms:

Anti-Infective Agents
RNA Virus Infections
Diarrhea
Rotavirus Infections
Signs and Symptoms, Digestive
Reoviridae Infections
Infection

Pharmacologic Actions
Virus Diseases
Signs and Symptoms
Antiparasitic Agents
Therapeutic Uses
Nitazoxanide

ClinicalTrials.gov processed this record on September 10, 2009