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Recurrent Wheezing in Infants: Risk Factors and Prevention With Probiotics.

NCT02113072 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-12-04

No results posted yet for this study

Summary

The purpose of this study is to evaluate whether Probiotics promote reduction of recurrent wheezing in infants, stimulating the immune system to Th1 response.

Conditions

  • Respiratory Tract Diseases
  • Wheezing

Interventions

DRUG

Beclomethasone

The wheezing infants will be using the inhaled corticosteroid beclomethasone 50mcg - 02 jets per day (100mcg/dia).

DRUG

Probiotics

Lyophilized form, each sachet containing 1 g of the probiotic, to be used in addition to milk, juice or yoghurt in the first morning meal once daily for 60 days.

DRUG

Placebo

The placebo will be supplied in the same way with the same organoleptic characteristics of formula with probiotics, 1 g sachet for 60 days, in the juice, milk or yoghurt.

Sponsors & Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

    collaborator OTHER_GOV

  • Universidade Federal de Pernambuco

    lead OTHER

Principal Investigators

  • Geórgia V. Araújo, Doctor · Universidade Federal de Pernambuco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
23 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2014-08-31
Completion
2014-11-30

Countries

  • Brazil

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02113072 on ClinicalTrials.gov