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Completed

NCT Number: NCT00981877

Probiotics in the Management of Acute Rotavirus Diarrhea in Bolivian Children

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.

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Key information

Conditions

Diarrhea Infections Pathological Conditions, Signs and Symptoms RNA Virus Infections Reoviridae Infections Rotavirus Infection Rotavirus Infections Signs and Symptoms Signs and Symptoms, Digestive Virus Diseases

Age range

1 month–23 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Pediatrico Albina Patino

Cochabamba, Bolivia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GB (Florestor)

Drug

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

Other names: Florestor, Bioflora

GRALB

Drug

mixed probiotic preparation 1 gram twice daily for 5 days.

Other names: Probiotik, mixed probiotic

GC (placebo)

Drug

Placebo 1 gram twice daily for 5 days.

Other names: Placebo

Primary outcomes

  1. Duration of diarrhea

    Time frame: within the first 72 hours during hospitalization

Secondary outcomes

  1. Duration of fever

    Time frame: the first 72 hours during hospitalization

  2. Duration of vomiting

    Time frame: the first 72 hours during hospitalization

  3. Duration of hospitalization

    Time frame: 4 days

Sponsors and collaborators

Lead sponsor

Centro Pediatrico Albina de Patino

Other

Collaborators

  • Instituto de Nutrición y Tecnología de los Alimentos

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Sep 22, 2009
Registry last updated
Sep 22, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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