跳至主要内容
临床试验/NCT01737983
NCT01737983已完成4 期

Lactobacillus Reuteri Reduces Pulmonary Exacerbations and Upper Respiratory Tract Infections in CF Patients With Mild-to-moderate Lung Disease. LR Administration Might Have a Beneficial Effect on the Disease Course of Cystic Fibrosis.

Azienda Policlinico Umberto I2 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2009年5月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
61
试验地点
2
主要终点
Efficacy

研究概览

简要总结

The purpose of this study is to evaluate in patients with cystic fibrosis the effect of Lactobacillus Reuteri (LR) on the rate of respiratory exacerbations and of the infections of both upper respiratory and gastrointestinal tracts.

详细描述

The hallmarks of cystic fibrosis (CF) are recurrent severe and destructive pulmonary inflammation and infection, beginning in early childhood and leading to morbidity and mortality due to respiratory failure. During the disease, most children become colonized with Pseudomonas aeruginosa (PA) and undergo progressive impairment of respiratory function. Therefore, patients colonized with Pseudomonas are at increased risk for pulmonary infections and persistent inflammation and have a decrease in survival rate. In an attempt to reduce the rate and severity of pulmonary exacerbations, children with CF are put on heavy load of antibiotics.

Intestinal inflammation is another typical finding in CF patients and gut bacterial overgrowth may be present.

Probiotics are live bacteria administered orally, successfully used in children with acute gastroenteritis, as well as in preventing and treating atopic diseases in children. In addition, probiotics have been used as adjuvant therapy in patients with pouchitis and inflammatory bowel diseases. Interestingly, probiotic supplementation is able to reduce the incidence of fever, child care absences, antibiotic prescription and to prevent nosocomial gastrointestinal and respiratory infections. The effect of probiotics may be through improvement of intestinal barrier function and modulation of immune response. The latter mechanism could well explain the clinical effects of probiotics observed in extraintestinal diseases.

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 42 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Forced expiratory volume in the 1st second (FEV1) > 70%.
  • No inhaled or systemic steroids.
  • No anti-inflammatory drugs, antileukotrienes and mast cell membrane stabilizers.
  • No serious organ involvement.

排除标准

  • History of pulmonary exacerbation or upper respiratory infection in the previous two months.
  • Changes in medications in the past two months.
  • History of hemoptysis in the past two months.

结局指标

主要结局

Efficacy

时间窗: 6 months of observation

Evaluate number of episodes of pulmonary exacerbations that were diagnosed by increase in pulmonary symptoms and airway secretions requiring oral or intravenous antibiotics.

efficacy

时间窗: 6 months of observation

Evaluate number of gastrointestinal and upper respiratory tract infections.

次要结局

  • efficacy(6 months of observation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Giovanni Di Nardo

MD

Azienda Policlinico Umberto I

研究点 (2)

Loading locations...

相似试验