Use of Nitazoxanide and Probiotics in Acute Diarrhea Secondary to Rotavirus
This study has been completed.
Sponsor:
Centro Pediatrico Albina de Patino
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
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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:
|
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 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 June 18, 2013