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临床试验/NCT01961661
NCT01961661已完成3 期

Effect of Probiotics on Intestinal Inflammation and Microflora in Cystic Fibrosis: a Pilot Study

Federico II University1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2009年9月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
22
试验地点
1
主要终点
Modification of intestinal inflammation

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 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 aim of the study is 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 aim is to study the effect of microflora modification on intestinal and extraintestinal inflammation 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
Triple (Participant, Care Provider, 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

入选标准

  • 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 (FEV1) 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

Modification of intestinal inflammation

时间窗: baseline and after 1 month of treatment

Evaluation of intestinal inflammation at baseline and 1 month after treatment

change in intestinal microflora composition

时间窗: baseline and 1 month after treatment

Modification of Fluorescent in Situ Hybridization profile of intestinal microflora at baseline and 1 month of treatment

次要结局

未报告次要终点

研究者

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alfredo Guarino

Full professor of Pediatrics

Federico II University

研究点 (1)

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