Randomized Controlled Clinical Trial to Evaluate the Efficacy of Supplementation With L. Reuteri + Vit. D3 in Asthmatic Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Reduction of allergic bronchial inflammation
研究概览
简要总结
The purpose of this project is to evaluate in a randomized clinical trial, double-blind, controlled, the effects of a dietary supplement containing Lactobacillus reuteri DSM 17938 and vitamin D3 in reducing bronchial inflammation and improve asthma control in patients in children with mild / moderate persistent asthma .
详细描述
To evaluate if the supplementation for three months with Lactobacillus reuteri DSM 17938 (108 CFU) + Vitamin D3 (400 IU) result in a reduction of the degree of allergic bronchial inflammation, measured with the Fractional exhaled nitric oxide (FeNO) and with a series of markers of bronchial inflammation (measured at 'beginning and at the end of the treatment on exhaled condensate): Interleukin 2(IL-2); Interleukin 4 (IL-4); Interleukin 10(IL-10); Interferon γ (IFN-γ).
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 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 6 and 14 years old, of both sexes
- •Diagnosis of mild / moderate persistent asthma (GINA step 2/3)
- •Allergy mite (Dermatophagoides farinae and pteronyssinus + + + / + + + +)
- •Levels of vitamin 25 (OH) D <30 ng / ml
- •Signature of the informed consent of one parent or a legal representative
排除标准
- •Cardiovascular disease or systemic
- •anatomical abnormalities
- •Other respiratory diseases
- •Taking probiotics and / or prebiotics in the previous 2 weeks
- •Taking vitamin D or systemic corticosteroids within 4 weeks
- •Participation in other clinical trials
研究组 & 干预措施
Reuterin D3 drops
Lactobacillus reuteri DSM 17938 (108 CFU) + Vitamin D3 (400 IU) 5 drops/day for 3 months (Reuterin D3 drops)
干预措施: Reuterin D3 drops (Drug)
Placebo
The patients will receive 5 drops/day of placebo for 3 months
干预措施: Placebo (Other)
结局指标
主要结局
Reduction of allergic bronchial inflammation
时间窗: Up to 3 months
Reduction of a series of markers of bronchial inflammation: IL-2; IL-4; IL-10; IFN-γ.
次要结局
- Improvement of asthma control by C-ACT(Up to 3 months)
- Improvement of asthma control by reduction of bronchodilator(Up to 3 months)
- Improvement of asthma control by improvement of FEV-1(Up to 3 months)
研究者
Prof. Michele Miraglia del Giudice
Prof.
University of Campania "Luigi Vanvitelli"