跳至主要内容
临床试验/NCT01837355
NCT01837355终止不适用

Modulation of Intestinal and Pulmonary Inflammation by Lactobacillus Rhamnosus Diet Supplementation in Pediatric Cystic Fibrosis (MoHuM-1)

Cantonal Hospital of St. Gallen2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2013年2月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
68
试验地点
2
主要终点
Change from baseline at w12 and w24 in pulmonary calprotectin levels

研究概览

简要总结

Pulmonary inflammation is an independent risk factor for disease progression in cystic fibrosis patients (CF). Yet, no effective treatment is known to reduce this detrimental inflammation. Dysbiosis of the gut microbiota has been linked to inflammation in several inflammatory diseases. As children with CF have different faecal microbiota from their healthy siblings, modulating gut microbiota by lactobacillus rhamnosus diet supplementation might be a strategy to target the inflammatory state in CF. Study subjects (CF or healthy control) will receive either placebo or lactobacillus rhamnosus once daily as dietary supplementation for 12 weeks. After a one-week washout phase, they will be switched for another 12 weeks to the other trial arm. Effect on in intestinal and pulmonary inflammation as well as clinical outcome will be studied.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
6 Years 至 20 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • moderate to severe CF disease

排除标准

  • acute gastroenteritis 2 weeks prior to inclusion
  • chronic disease other than CF (except CF associated disorders)
  • oral or parenteral antibiotics 2 weeks prior to inclusion
  • systemic steroids 4 weeks prior to inclusion
  • any probiotic intake

研究组 & 干预措施

Lactobacillus rhamnosus

Experimental

lactobacillus rhamnosus once daily for 12 weeks

干预措施: Lactobacillus rhamnosus (Dietary Supplement)

Placebo

Placebo Comparator

placebo once daily for 12 weeks

干预措施: Placebo (Dietary Supplement)

结局指标

主要结局

Change from baseline at w12 and w24 in pulmonary calprotectin levels

时间窗: Baseline, w12, w24

Baseline, week 12 change from baseline, week 24 change from week 12

Change from baseline at w12 and w24 in fecal calprotectin levels

时间窗: Baseline, week 12, week 24

Baseline, week 12 change from baseline, week 24 change from week 12

次要结局

未报告次要终点

研究者

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

Christian R Kahlert, MD

Consultant Pediatric Infectious Diseases

Cantonal Hospital of St. Gallen

研究点 (2)

Loading locations...

相似试验