Clinical Trial: Probiotics in the Management of Acute Rotavirus Diarrhea in Bolivian Children

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Centro Pediatrico Albina de Patino

Current Primary Outcome: Duration of diarrhea [ Time Frame: within the first 72 hours during hospitalization ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Duration of fever [ Time Frame: the first 72 hours during hospitalization ]
  • Duration of vomiting [ Time Frame: the first 72 hours during hospitalization ]
  • Duration of hospitalization [ Time Frame: 4 days ]


Original Secondary Outcome: Same as current

Information By: Centro Pediatrico Albina de Patino

Dates:
Date Received: September 18, 2009
Date Started: July 2007
Date Completion:
Last Updated: September 21, 2009
Last Verified: September 2009