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Use of Nitazoxanide and Probiotics in Acute Diarrhea Secondary to Rotavirus

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ClinicalTrials.gov Identifier: NCT00683982
Recruitment Status : Completed
First Posted : May 26, 2008
Last Update Posted : May 26, 2008
Sponsor:
Information provided by:
Centro Pediatrico Albina de Patino

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?

Condition or disease Intervention/treatment Phase
Diarrhea Rotavirus Infection Drug: Nitazoxanide Drug: Probiotic mix preparation Other: Oral hydration solutions Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
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
Study Start Date : August 2007
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

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U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Duration of diarrhea [ Time Frame: Hours ]

Secondary Outcome Measures :
  1. Duration of hospitalization [ Time Frame: hours ]


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Ages Eligible for Study:   up to 24 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: May 26, 2008    Key Record Dates
Last Update Posted: May 26, 2008
Last Verified: May 2008

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
Pharmaceutical Solutions
Nitazoxanide
Antiparasitic Agents
Anti-Infective Agents