Trial | NCT00981877  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    76
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.
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 Started
Jul 31
2007
Primary Completion
Mar 31
2008
Study Completion
Mar 31
2008
Last Update
Sep 22
2009
Estimate

Drug GB (Florestor)

S. Boulardii preparation of 1 gram twice daily for 5 days

  • Other names: Florestor, Bioflora

Drug GRALB

mixed probiotic preparation 1 gram twice daily for 5 days.

  • Other names: Probiotik, mixed probiotic

Drug GC (placebo)

Placebo 1 gram twice daily for 5 days.

  • Other names: Placebo

1 Active Comparator

This group will receive S. Boulardii Probiotic and Oral rehydration as needed

2 Active Comparator

This group will receive a mixed Probiotic preparation and oral rehydration as needed

3 Placebo Comparator

This group will receive a placebo, and oral rehydration as needed

Criteria 

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
No Results Posted