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

NCT ID: NCT01564290

Last Updated: 2012-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-02-29

Brief Summary

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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

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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.

Conditions

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Acute Diarrhea Acute Gastroenteritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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probiotic

Probiotic product with Sacharomices Boulardii

Group Type PLACEBO_COMPARATOR

Placebo probiotic

Intervention Type DRUG

Lyophilized probiotic, containing 250 mg per sachet dosage to about 2 times a day for 5 days.

probiotic yogurt

Yogurt with Lactobacilus Rhamnonsus strain spp

Group Type ACTIVE_COMPARATOR

Probiotic yogurt

Intervention Type DIETARY_SUPPLEMENT

Lactobacilus Rhamnonsus 100000000 UFC per mL. Dosage 50 mL twice daily fo 5 days.

Interventions

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Probiotic yogurt

Lactobacilus Rhamnonsus 100000000 UFC per mL. Dosage 50 mL twice daily fo 5 days.

Intervention Type DIETARY_SUPPLEMENT

Placebo probiotic

Lyophilized probiotic, containing 250 mg per sachet dosage to about 2 times a day for 5 days.

Intervention Type DRUG

Other Intervention Names

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Florestor

Eligibility Criteria

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Inclusion Criteria

* All acute diarrhea

Exclusion Criteria

* Severe malnourishment
* Severe dehydration
* Systemic infections
Minimum Eligible Age

10 Months

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centro Pediatrico Albina de Patino

OTHER

Sponsor Role lead

Responsible Party

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Carlos Teran

Teaching and Research chief

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Giuseppe E Grandy, MD MSc

Role: PRINCIPAL_INVESTIGATOR

Centro Pediatrico Albina Patino

Richard M Soria, MD

Role: STUDY_DIRECTOR

Centro Pediatrico Albina Patino

Sdenka Jose, MD

Role: STUDY_CHAIR

Centro Pediatrico Albina Patino

Locations

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Centro Pediatrico Albina Patino

Cochabamba, Departamento de Cochabamba, Bolivia

Site Status

Countries

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Bolivia

Other Identifiers

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protprobiot2010

Identifier Type: -

Identifier Source: org_study_id

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