Recurrent Wheezing in Infants: Risk Factors and Prevention With Probiotics, a Randomized Clinical Trial, Double-blind, Placebo Controlled.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Recurrent wheezing and cytokine assay.
研究概览
简要总结
The purpose of this study is to evaluate whether Probiotics promote reduction of recurrent wheezing in infants, stimulating the immune system to Th1 response.
详细描述
OBJECTIVES
GENERAL
- Assess whether probiotic supplementation reduces the frequency of recurrent wheezing in infants .
SPECIFIC
- Identifying the presence of environmental and genetic factors to recurrent wheezing in infants, which may serve as major confounders of the effect of probiotics in the sample studied risk factors .
- Check the effect of probiotics as the recurrence of wheezing in infants.
- Evaluate the effects of probiotics on the immune response of the infant wheezing , through the measurement of IL - 10 , IL - 12 and Interferon-gama before and after intervention with the use of probiotics .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Months 至 23 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Probiotics & Beclomethasone
It will be supplied in lyophilized form, in 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.
Beclomethasone HFA 50mcg spray - 100 mcg/day as initial treatment for primary and wheezing in this age group, at doses considered minimal, for 4 months.
干预措施: Beclomethasone (Drug)
Probiotics & Beclomethasone
It will be supplied in lyophilized form, in 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.
Beclomethasone HFA 50mcg spray - 100 mcg/day as initial treatment for primary and wheezing in this age group, at doses considered minimal, for 4 months.
干预措施: Probiotics (Drug)
Beclomethasone & Placebo
The placebo will be supplied in the same way with the same organoleptic characteristics of formula with probiotics. It will be supplied in lyophilized form in each sachet containing 1 g of placebo, to be used in addition to milk, juice or yoghurt in the first morning meal once daily for 60 days.
干预措施: Beclomethasone (Drug)
Beclomethasone & Placebo
The placebo will be supplied in the same way with the same organoleptic characteristics of formula with probiotics. It will be supplied in lyophilized form in each sachet containing 1 g of placebo, to be used in addition to milk, juice or yoghurt in the first morning meal once daily for 60 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Recurrent wheezing and cytokine assay.
时间窗: After 2 months of using probiotic, will be assessed the recurrence of wheezing and cytokine assay.
After eight weeks of using probiotics, infants will undergo new measurement of cytokines IL-10, IL-12 and INF-γ, with the objective to evaluate the immune response of probiotics in both groups. Before and at the end of each period, the patient will undergo physical examination and parents or guardians to an interview, to assess the occurrence of wheezing attacks. These data will be analyzed to assess whether supplementation with probiotics reduces the frequency of wheezing in infants.
次要结局
未报告次要终点
研究者
Geórgia Véras de Araújo
Postgraduate in Allergy and Clinical Immunology.
Universidade Federal de Pernambuco