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Probiotics in the Management of Acute Rotavirus Diarrhea in Bolivian Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00981877
Recruitment Status : Completed
First Posted : September 22, 2009
Last Update Posted : September 22, 2009
Sponsor:
Collaborator:
Instituto de Nutrición y Tecnología de los Alimentos
Information provided by:
Centro Pediatrico Albina de Patino

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diarrhea Rotavirus Infection Drug: GB (Florestor) Drug: GRALB Drug: GC (placebo) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Probiotics in the Management of Acute Rotavirus Diarrhea in Bolivian Children: Randomized Double-blind, Controlled Trial Using Two Different Preparations
Study Start Date : July 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

Arms and Interventions
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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 Name: 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 Name: 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 Name: Placebo


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

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   1 Month to 23 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00981877


Locations
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Bolivia
Centro Pediatrico Albina Patino
Cochabamba, Bolivia
Sponsors and Collaborators
Centro Pediatrico Albina de Patino
Instituto de Nutrición y Tecnología de los Alimentos
Investigators
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Study Director: Richard M Soria, MD Centro Pediatrico Albina Patino
Principal Investigator: Giuseppe E Grandy, Md Centro Pediatrico Albina Patino - Instituto de Nutricion y Tecnologia de los Alimentos
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Giuseppe Grandy Aranda, Centro Pediatrico Albina de Patino/ Departamento de Gastroenterologia y Nutricion
ClinicalTrials.gov Identifier: NCT00981877    
Other Study ID Numbers: protrota2007
First Posted: September 22, 2009    Key Record Dates
Last Update Posted: September 22, 2009
Last Verified: September 2009
Keywords provided by Centro Pediatrico Albina de Patino:
acute diarrhea
rotavirus
probiotic
children
Additional relevant MeSH terms:
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Rotavirus Infections
Diarrhea
Signs and Symptoms, Digestive
Reoviridae Infections
 RNA Virus Infections
Virus Diseases
Infections