Use of Probiotic Yogurt in the Treatment of Acute Diarrhea in Children
|ClinicalTrials.gov Identifier: NCT01564290|
Recruitment Status : Completed
First Posted : March 27, 2012
Last Update Posted : March 27, 2012
|Condition or disease||Intervention/treatment||Phase|
|Acute Diarrhea Acute Gastroenteritis||Dietary Supplement: Probiotic yogurt Drug: Placebo probiotic||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Use of Probiotic Yogurt in the Treatment of Acute Diarrhea in Children: A Randomized Double-blind Trial|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||February 2012|
Placebo Comparator: probiotic
Probiotic product with Sacharomices Boulardii
Drug: Placebo probiotic
Lyophilized probiotic, containing 250 mg per sachet dosage to about 2 times a day for 5 days.
Other Name: Florestor
Active Comparator: probiotic yogurt
Yogurt with Lactobacilus Rhamnonsus strain spp
Dietary Supplement: Probiotic yogurt
Lactobacilus Rhamnonsus 100000000 UFC per mL. Dosage 50 mL twice daily fo 5 days.
- Duration of diarrhea [ Time Frame: five days ]participants will be followed for the duration of hospital stay, an expected average of 5 days
- Duration of fever [ Time Frame: five days ]participants will be followed for the duration of hospital stay, an expected average of 5 days
- duration of vomiting [ Time Frame: five days ]participants will be followed for the duration of hospital stay, an expected average of 5 days
- duration of hospitalization [ Time Frame: five days ]participants will be followed for the duration of hospital stay, an expected average of 5 days
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01564290
|Centro Pediatrico Albina Patino|
|Cochabamba, Bolivia, 0866|
|Principal Investigator:||Giuseppe E Grandy, MD MSc||Centro Pediatrico Albina Patino|
|Study Director:||Richard M Soria, MD||Centro Pediatrico Albina Patino|
|Study Chair:||Sdenka Jose, MD||Centro Pediatrico Albina Patino|