Use of Probiotic Yogurt in the Treatment of Acute Diarrhea in Children

NCT01564290 — Phase 4, Completed, 54 participants, Centro Pediatrico Albina de Patino

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Use of Probiotic Yogurt in the Treatment of Acute Diarrhea in Children: A Randomized Double-blind Trial

Registry	NCT01564290
Status	Completed
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	54 (Actual)
Sponsor	Centro Pediatrico Albina de Patino (Other)
Conditions	Acute Diarrhea, Acute Gastroenteritis
Interventions	Probiotic yogurt, Placebo probiotic (Dietary supplement, drug)
Dates	start 2011-02-01, primary completion 2011-08-01, completion 2012-02-01, first posted 2012-03-27, last updated 2012-03-27
Locations	1 site in Bolivia

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
probiotic	Placebo comparator	Drug: Placebo probiotic	Probiotic product with Sacharomices Boulardii
probiotic yogurt	Active comparator	Dietary Supplement: Probiotic yogurt	Yogurt with Lactobacilus Rhamnonsus strain spp

Probiotic yogurt (Dietary supplement): Lactobacilus Rhamnonsus 100000000 UFC per mL. Dosage 50 mL twice daily fo 5 days.
Placebo probiotic (Drug), also known as Florestor: Lyophilized probiotic, containing 250 mg per sachet dosage to about 2 times a day for 5 days.

+Outcome measures

Primary outcomes

Duration of diarrhea [five days]: participants will be followed for the duration of hospital stay, an expected average of 5 days

Secondary outcomes

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

+Eligibility

Sex: All, ages: 10 Months to 36 Months

Inclusion Criteria:

* All acute diarrhea

Exclusion Criteria:

* Severe malnourishment
* Severe dehydration
* Systemic infections

+Locations (1)

Facility	City	Country	Status
Centro Pediatrico Albina Patino	Cochabamba, Cochabamba	Bolivia

+Investigators

Giuseppe E Grandy, MD MSc, Principal investigator, Centro Pediatrico Albina Patino
Richard M Soria, MD, Study director, Centro Pediatrico Albina Patino
Sdenka Jose, MD, Study chair, Centro Pediatrico Albina Patino