Use of Probiotic Yogurt in the Treatment of Acute Diarrhea in Children
NCT ID: NCT01564290
Last Updated: 2012-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
54 participants
INTERVENTIONAL
2011-02-28
2012-02-29
Brief Summary
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Detailed Description
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Objectives: To evaluate the effect of the probiotic yogurt in the treatment of children who are between 10 months and 3 years old with acute non-dysenteric diarrhea.
Methods: A randomized clinical trial, controlled, double-blind. The investigators will have two groups of patients : One group will receive Lactobacillus Rahmnosus in a yogurt presentation and the other one will receive Sacharomyces boulardii in a lyophilized form ; the parameters of evaluation are going to be the number of diarrhea stools by day, number of vomiting episodes, hours with fever, nutritional and immunization state.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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probiotic
Probiotic product with Sacharomices Boulardii
Placebo probiotic
Lyophilized probiotic, containing 250 mg per sachet dosage to about 2 times a day for 5 days.
probiotic yogurt
Yogurt with Lactobacilus Rhamnonsus strain spp
Probiotic yogurt
Lactobacilus Rhamnonsus 100000000 UFC per mL. Dosage 50 mL twice daily fo 5 days.
Interventions
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Probiotic yogurt
Lactobacilus Rhamnonsus 100000000 UFC per mL. Dosage 50 mL twice daily fo 5 days.
Placebo probiotic
Lyophilized probiotic, containing 250 mg per sachet dosage to about 2 times a day for 5 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Severe dehydration
* Systemic infections
10 Months
36 Months
ALL
No
Sponsors
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Centro Pediatrico Albina de Patino
OTHER
Responsible Party
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Carlos Teran
Teaching and Research chief
Principal Investigators
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Giuseppe E Grandy, MD MSc
Role: PRINCIPAL_INVESTIGATOR
Centro Pediatrico Albina Patino
Richard M Soria, MD
Role: STUDY_DIRECTOR
Centro Pediatrico Albina Patino
Sdenka Jose, MD
Role: STUDY_CHAIR
Centro Pediatrico Albina Patino
Locations
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Centro Pediatrico Albina Patino
Cochabamba, Departamento de Cochabamba, Bolivia
Countries
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Other Identifiers
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protprobiot2010
Identifier Type: -
Identifier Source: org_study_id
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