Probiotics in the Management of Acute Rotavirus Diarrhea in Bolivian Children

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diarrhea, Rotavirus Infection

Intervention / Treatment
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* Drug: GB (Florestor)
* Drug: GRALB
* Drug: GC (placebo)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 23 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of diarrhea |  | within the first 72 hours during hospitalization | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute diarrhea, rotavirus, probiotic, children