NCT00981877

Probiotics in the Management of Acute Rotavirus Diarrhea in Bolivian Children

Probiotics in the Management of Acute Rotavirus Diarrhea in Bolivian Children: Randomized Double-blind, Controlled Trial Using Two Different Preparations

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Centro Pediatrico Albina de Patino · Academic / Other
• Sex: All
• Age: 1 Month – 23 Months
• Healthy volunteers: Not accepted

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.

Conditions

• Diarrhea
• Rotavirus Infection

Interventions

Type	Name	Description
DRUG	GB (Florestor)	S. Boulardii preparation of 1 gram twice daily for 5 days
DRUG	GRALB	mixed probiotic preparation 1 gram twice daily for 5 days.
DRUG	GC (placebo)	Placebo 1 gram twice daily for 5 days.

Timeline

• Start date: 2007-07-01
• Primary completion: 2008-03-01
• Completion: 2008-03-01
• First posted: 2009-09-22
• Last updated: 2009-09-22

Locations

1 site across 1 country: Bolivia