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

Phase 4

Completed

• Conditions: Acute Diarrhea; Acute Gastroenteritis
• Interventions: Drug: Placebo probiotic; Dietary Supplement: Probiotic yogurt

• Registration Number: NCT01564290
• Lead Sponsor: Centro Pediatrico Albina de Patino

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.

Study Timeline

• Study Start: 2011-02
• Primary Completion: 2011-08
• Study First Submitted: 2011-10-29
• Study Completion: 2012-02
• Status Verified: 2012-03
• Study First Submitted QC: 2012-03-26
• Last Update Submitted: 2012-03-26
• Study First Posted: 2012-03-27
• Last Update Posted: 2012-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• All acute diarrhea

Exclusion Criteria

• Severe malnourishment
• Severe dehydration
• Systemic infections

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
probiotic	Placebo probiotic	Probiotic product with Sacharomices Boulardii
probiotic yogurt	Probiotic yogurt	Yogurt with Lactobacilus Rhamnonsus strain spp

Primary Outcome Measures

Name	Time	Method
Duration of diarrhea	five days	participants will be followed for the duration of hospital stay, an expected average of 5 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Centro Pediatrico Albina Patino; 🇧🇴 Cochabamba, Bolivia