Probiotics in the Management of Acute Rotavirus Diarrhea in Bolivian Children

Not Applicable

Completed

• Conditions: Rotavirus Infection; Diarrhea
• Interventions: Drug: GB (Florestor); Drug: GRALB; Drug: GC (placebo)

• Registration Number: NCT00981877
• Lead Sponsor: Centro Pediatrico Albina de Patino

Brief Summary

The purpose of this study is to determine the effect of probiotics in rotavirus acute diarrhea in children. The investigators will compare the effect of two different probiotics products.

Detailed Description

Acute diarrhea remains being the second most frequent infectious condition in children, producing a high number of admissions yearly. In children below one year of age, rotavirus represents the main etiologic agent, both in developed and developing countries. In Bolivia, acute diarrhea affects about 30% of the group below 5 years of age. Probiotics appear as one of the alternatives currently under discussion. Also, evidence available suggests that probiotics shorten the time of diarrhea and therefore the time of rotavirus excretion. In daily practice, we are often limited by the type and number of probiotics products locally available; moreover, information about combined products is scarce. With this in mind, in this study we compared the efficacy of two commercially available products.

Study Timeline

• Study Start: 2007-07
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Status Verified: 2009-09
• Study First Submitted: 2009-09-18
• Study First Submitted QC: 2009-09-21
• Last Update Submitted: 2009-09-21
• Study First Posted: 2009-09-22
• Last Update Posted: 2009-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

• Positive stool sample for rotavirus test

Exclusion Criteria

• Severe malnourishment
• Severe dehydration
• Use of antibiotics, probiotics or nitazoxanide 2 weeks before admission
• Systemic infections
• Severe chronic disease
• Mixed enteric infections besides rotavirus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	GB (Florestor)	This group will receive S. Boulardii Probiotic and Oral rehydration as needed
2	GRALB	This group will receive a mixed Probiotic preparation and oral rehydration as needed
3	GC (placebo)	This group will receive a placebo, and oral rehydration as needed

Primary Outcome Measures

Name	Time	Method
Duration of diarrhea	within the first 72 hours during hospitalization

Secondary Outcome Measures

Name	Time	Method
Duration of hospitalization	4 days
Duration of vomiting	the first 72 hours during hospitalization
Duration of fever	the first 72 hours during hospitalization

Trial Locations

Locations (1)

Centro Pediatrico Albina Patino; 🇧🇴 Cochabamba, Bolivia