Acute Diarrhea, Acute Gastroenteritis
Conditions
Keywords
acute diarrhea, probiotics, children
Brief summary
The purpose of this study is to determine the effect of probiotic yogurt in acute watery diarrhea in children. The investigators will compare the effect of two different probiotics products.
Detailed description
Background: Acute Gastroenteritis is one of the most and frequent disease in the childhood, considering the advances in treatment, Lactobacillus Rahmnosus has being well described as a probiotic who reduces the number of days of hospitalization and also de the severity. 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.
Interventions
DIETARY_SUPPLEMENTProbiotic yogurt
Lactobacilus Rhamnonsus 100000000 UFC per mL. Dosage 50 mL twice daily fo 5 days.
Lyophilized probiotic, containing 250 mg per sachet dosage to about 2 times a day for 5 days.
Sponsors
Centro Pediatrico Albina de Patino
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Months to 36 Months
Healthy volunteers
No
Inclusion criteria
* All acute diarrhea
Exclusion criteria
* Severe malnourishment * Severe dehydration * Systemic infections
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of diarrhea | five days | participants will be followed for the duration of hospital stay, an expected average of 5 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of fever | five days | participants will be followed for the duration of hospital stay, an expected average of 5 days |
| duration of vomiting | five days | participants will be followed for the duration of hospital stay, an expected average of 5 days |
| duration of hospitalization | five days | participants will be followed for the duration of hospital stay, an expected average of 5 days |
Countries
Bolivia
Outcome results
None listed