Use of Nitazoxanide and Probiotics in Acute Diarrhea Secondary to Rotavirus

This study has been completed.
Sponsor:
Information provided by:
Centro Pediatrico Albina de Patino
ClinicalTrials.gov Identifier:
NCT00683982
First received: May 22, 2008
Last updated: May 23, 2008
Last verified: May 2008
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
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:


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
Active Comparator: 1
This group will receive oral nitazoxanide preparation
Drug: Nitazoxanide
Nitazoxanide 15mg/Kg/day twice day for 3 days
Other Name: 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 Name: 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Keywords provided by Centro Pediatrico Albina de Patino:
nitazoxanide
Probiotics
Diarrhea
Rotavirus
Children

Additional relevant MeSH terms:
Diarrhea
Rotavirus Infections
Signs and Symptoms, Digestive
Signs and Symptoms
Reoviridae Infections
RNA Virus Infections
Virus Diseases
Nitazoxanide
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014