Probiotics in the Management of Acute Rotavirus Diarrhea in Bolivian Children

September 21, 2009 updated by: Centro Pediatrico Albina de Patino

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bolivia
      • Cochabamba, Bolivia
        • Centro Pediatrico Albina Patino

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 1 year (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
This group will receive S. Boulardii Probiotic and Oral rehydration as needed
Drug: GB (Florestor)
S. Boulardii preparation of 1 gram twice daily for 5 days
Other Names:
  • Florestor, Bioflora
Active Comparator: 2
This group will receive a mixed Probiotic preparation and oral rehydration as needed
Drug: GRALB
mixed probiotic preparation 1 gram twice daily for 5 days.
Other Names:
  • Probiotik, mixed probiotic
Placebo Comparator: 3
This group will receive a placebo, and oral rehydration as needed
Drug: GC (placebo)
Placebo 1 gram twice daily for 5 days.
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of diarrhea
Time Frame: within the first 72 hours during hospitalization
within the first 72 hours during hospitalization

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of fever
Time Frame: the first 72 hours during hospitalization
the first 72 hours during hospitalization
Duration of vomiting
Time Frame: the first 72 hours during hospitalization
the first 72 hours during hospitalization
Duration of hospitalization
Time Frame: 4 days
4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Pediatrico Albina de Patino

Collaborators

Instituto de Nutrición y Tecnología de los Alimentos

Investigators

  • Principal Investigator: Giuseppe E Grandy, Md, Centro Pediatrico Albina Patino - Instituto de Nutricion y Tecnologia de los Alimentos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

September 18, 2009

First Submitted That Met QC Criteria

September 21, 2009

First Posted (Estimate)

September 22, 2009

Study Record Updates

Last Update Posted (Estimate)

September 22, 2009

Last Update Submitted That Met QC Criteria

September 21, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • protrota2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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