Use of Nitazoxanide and Probiotics in Acute Diarrhea Secondary to Rotavirus

Diarrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00683982
• Other study ID #: PROT261179
• Secondary ID: PROT261179B
• Status: Completed
• Phase: N/A
• First received: May 22, 2008
• Last updated: May 23, 2008
• Start date: August 2007
• Est. completion date: May 2008

Study information

• Verified date: May 2008
• Source: Centro Pediatrico Albina de Patino
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bolivia: Ministry of Health
• Study type: Interventional

Clinical Trial 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?

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 24 Months

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diarrhea
• Rotavirus Infection
• Rotavirus Infections

Intervention

Drug:
• Nitazoxanide
Nitazoxanide 15mg/Kg/day twice day for 3 days
• Probiotic mix preparation
Probiotic preparation 1 gram twice a day for 5 days

Other:
• Oral hydration solutions
Oral hydration solutions as needed

Locations

Country	Name	City	State
Bolivia	Centro Pediatrico Albina Patiño	Cochabamba

Sponsors (1)

Lead Sponsor	Collaborator
Centro Pediatrico Albina de Patino

Country where clinical trial is conducted

Bolivia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of diarrhea		Hours	Yes
Secondary	Duration of hospitalization		hours	Yes