A Phase 4 interventional study of Probiotic yogurt and Placebo probiotic in Acute Diarrhea and Acute Gastroenteritis, sponsored by Centro Pediatrico Albina de Patino. Completed at 1 site in Bolivia. Open to participants aged 10 Months to 36 Months. Per ClinicalTrials.gov, last updated 2012-03-27.
Sponsored by Centro Pediatrico Albina de Patino · Phase 4, Interventional, and Treatment
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.
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.
243 studies on the registry are indexed under Gastroenteritis; 15 are open to participants now.
This study's enrollment of 54 is below the median of 126 across 160 interventional studies indexed under Gastroenteritis.
Browse Gastroenteritis studies →Centro Pediatrico Albina de Patino is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Probiotic product with Sacharomices Boulardii
Drug: Placebo probiotic
Yogurt with Lactobacilus Rhamnonsus strain spp
Dietary Supplement: Probiotic 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.
Also known as: Florestor
Duration of diarrhea
participants will be followed for the duration of hospital stay, an expected average of 5 days
Time frame: five days
Duration of fever
participants will be followed for the duration of hospital stay, an expected average of 5 days
Time frame: five days
duration of vomiting
participants will be followed for the duration of hospital stay, an expected average of 5 days
Time frame: five days
duration of hospitalization
participants will be followed for the duration of hospital stay, an expected average of 5 days
Time frame: five days
This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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Centro Pediatrico Albina de Patino