Recurrent Wheezing in Infants: Risk Factors and Prevention With Probiotics. (NCT02113072) | Clinical Trial Compass
CompletedPhase 3
Recurrent Wheezing in Infants: Risk Factors and Prevention With Probiotics.
Brazil60 participantsStarted 2014-04
Plain-language 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.
Who can participate
Age range6 Months – 23 Months
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Infants aged six months to two years incomplete.
* Infants who have recurrent wheezing in the past 3 months.
* Infants under use of proper technique of inhaled corticosteroids: beclomethasone HFA spray - 50 mg - 2 times daily (100 mg / day) with spacer and face mask.
Exclusion Criteria:
* Patients who present congenital airway malformations, cystic fibrosis, chronic diseases in other systems, perinatal respiratory problems, allergy to the protein in cow's milk, intrathoracic tumors, Tuberculosis and Pulmonary Congenital immunodeficiencies, children who were premature: \<37 weeks gestational age.
* Use of other products containing probiotics in its composition with previous exposure or even study period.
* Infant in use of anti-leukotrienes.
* Use recent antibiotic.
What they're measuring
1
Recurrent wheezing and cytokine assay.
Timeframe: After 2 months of using probiotic, will be assessed the recurrence of wheezing and cytokine assay.