Effects of LGG Administration in Children With Cystic Fibrosis: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 5
- 主要终点
- Change of intestinal inflammation from baseline to 12 months of treatment
研究概览
简要总结
Cystic fibrosis (CF) is a complex systemic disease that mainly involves the respiratory and gastrointestinal (GI) tracts. The polymicrobial community composition of respiratory and GI tracts is influenced by both genetic and environmental factors. Children with CF may harbor an abnormal intestinal microflora, because of altered cystic fibrosis transmembrane conductance regulator (CFTR) function and heavy drug load (antibiotics, pancreatic enzymes and acid suppressors). The investigators have previously demonstrated that intestinal inflammation is highly frequent in CF children, being a major feature of intestinal involvement. In addition, specific probiotics significantly improved airway and GI inflammation in a preliminary trial. The investigators aim to characterize intestinal and respiratory microflora in CF patients and to investigate the effects of daily Lactobacillus GG (LGG) supplementation on both GI and airway microflora and the eventual relationship between probiotic assumption and clinical and inflammation markers. The investigators aim is to eventually improve the quality of life of CF patients, who often suffer from intestinal and respiratory progressive disease, through a non invasive intervention consisting in the supplementation of probiotic bacteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A confirmed diagnosis of CF documented by sweat chloride test over 60 mmol/L and confirmed by genotype analysis with the presence of F508del/F508del or F508del/other
- •Boys and girls between 2 and 16 years of age
- •Clinical stability at enrolment, defined as no clinical evidence of acute exacerbation, no modifications in the therapeutic regimen and no hospitalization in the last 2 weeks
- •Pancreatic insufficiency
- •Basal Forced Expiratory Volume 1 second above 50% of predicted value
排除标准
- •Colonization of respiratory tract with Burkholderia cepacia spp.
- •Steroid therapy within one month before enrolment
- •Pregnancy and fertile women taking oral contraceptives
- •Parenteral or oral antibiotics therapy within 2 weeks before enrolment
- •Regular assumption of probiotics
- •Regular assumption of azythromycin
结局指标
主要结局
Change of intestinal inflammation from baseline to 12 months of treatment
时间窗: every six months up to 18 months
Assessment of intestinal inflammation is performed four times. First time at enrollment, second time at the end of six months of observation. Third time after six months of treatment and fourth time after 12 months of treatment.
Change in the incidence of pulmonary exacerbations from baseline to 12 months of treatment
时间窗: every six months up to 18 months
The incidence of pulmonary exacerbation is assessed every six months. First evaluation from baseline to 6 months of observation. Second evaluation from randomization ( placebo/LGG) to 6 months of treatment and third evaluation after 12 months of treatment
次要结局
- Change in the incidence of hospital admission from baseline to 12 months of treatment(every six month up to 18 months)
- change in pulmonary function from baseline to 12 months of treatment (measured by Forced Expiratory Volume 1 sec (FEV1))(every six months up to 18 months)
研究者
Alfredo Guarino
Full Professor Of Pediatrics
Federico II University