Probiotics in the Management of Acute Rotavirus Diarrhea in Bolivian Children
Primary Purpose
Diarrhea, Rotavirus Infection
Status
Completed
Phase
Not Applicable
Locations
Bolivia
Study Type
Interventional
Intervention
GB (Florestor)
GRALB
GC (placebo)
Sponsored by
About this trial
This is an interventional treatment trial for Diarrhea focused on measuring acute diarrhea, rotavirus, probiotic, children
Eligibility 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
Sites / Locations
- Centro Pediatrico Albina Patino
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
1
2
3
Arm Description
This group will receive S. Boulardii Probiotic and Oral rehydration as needed
This group will receive a mixed Probiotic preparation and oral rehydration as needed
This group will receive a placebo, and oral rehydration as needed
Outcomes
Primary Outcome Measures
Duration of diarrhea
Secondary Outcome Measures
Duration of fever
Duration of vomiting
Duration of hospitalization
Full Information
NCT ID
NCT00981877
First Posted
September 18, 2009
Last Updated
September 21, 2009
Sponsor
Centro Pediatrico Albina de Patino
Collaborators
Instituto de Nutrición y Tecnología de los Alimentos
1. Study Identification
Unique Protocol Identification Number
NCT00981877
Brief Title
Probiotics in the Management of Acute Rotavirus Diarrhea in Bolivian Children
Official Title
Probiotics in the Management of Acute Rotavirus Diarrhea in Bolivian Children: Randomized Double-blind, Controlled Trial Using Two Different Preparations
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Centro Pediatrico Albina de Patino
Collaborators
Instituto de Nutrición y Tecnología de los Alimentos
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea, Rotavirus Infection
Keywords
acute diarrhea, rotavirus, probiotic, children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
76 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
This group will receive S. Boulardii Probiotic and Oral rehydration as needed
Arm Title
2
Arm Type
Active Comparator
Arm Description
This group will receive a mixed Probiotic preparation and oral rehydration as needed
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
This group will receive a placebo, and oral rehydration as needed
Intervention Type
Drug
Intervention Name(s)
GB (Florestor)
Other Intervention Name(s)
Florestor, Bioflora
Intervention Description
S. Boulardii preparation of 1 gram twice daily for 5 days
Intervention Type
Drug
Intervention Name(s)
GRALB
Other Intervention Name(s)
Probiotik, mixed probiotic
Intervention Description
mixed probiotic preparation 1 gram twice daily for 5 days.
Intervention Type
Drug
Intervention Name(s)
GC (placebo)
Other Intervention Name(s)
Placebo
Intervention Description
Placebo 1 gram twice daily for 5 days.
Primary Outcome Measure Information:
Title
Duration of diarrhea
Time Frame
within the first 72 hours during hospitalization
Secondary Outcome Measure Information:
Title
Duration of fever
Time Frame
the first 72 hours during hospitalization
Title
Duration of vomiting
Time Frame
the first 72 hours during hospitalization
Title
Duration of hospitalization
Time Frame
4 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
23 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard M Soria, MD
Organizational Affiliation
Centro Pediatrico Albina Patino
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Giuseppe E Grandy, Md
Organizational Affiliation
Centro Pediatrico Albina Patino - Instituto de Nutricion y Tecnologia de los Alimentos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Pediatrico Albina Patino
City
Cochabamba
Country
Bolivia
12. IPD Sharing Statement
Citations:
PubMed Identifier
22305197
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Probiotics in the Management of Acute Rotavirus Diarrhea in Bolivian Children
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