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

C

Centro Pediatrico Albina de Patino

Status and phase

Completed
Phase 4

Conditions

Acute Gastroenteritis
Acute Diarrhea

Treatments

Dietary Supplement: Probiotic yogurt
Drug: Placebo probiotic

Study type

Interventional

Funder types

Other

Identifiers

NCT01564290
protprobiot2010

Details and patient eligibility

About

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.

Full 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.

Enrollment

54 patients

Sex

All

Ages

10 to 36 months old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • All acute diarrhea

Exclusion criteria

  • Severe malnourishment
  • Severe dehydration
  • Systemic infections

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

54 participants in 2 patient groups, including a placebo group

probiotic
Placebo Comparator group
Description:
Probiotic product with Sacharomices Boulardii
Treatment:
Drug: Placebo probiotic
probiotic yogurt
Active Comparator group
Description:
Yogurt with Lactobacilus Rhamnonsus strain spp
Treatment:
Dietary Supplement: Probiotic yogurt

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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