Use of Probiotic Yogurt in the Treatment of Acute Diarrhea in Children
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|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|