Modulation of Intestinal and Pulmonary Inflammation by Lactobacillus Rhamnosus Diet Supplementation in Pediatric Cystic Fibrosis (MoHuM-1)
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
- 是
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
lactobacillus rhamnosus once daily for 12 weeks
干预措施: Lactobacillus rhamnosus (Dietary Supplement)
Placebo
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
Christian R Kahlert, MD
Consultant Pediatric Infectious Diseases
Cantonal Hospital of St. Gallen
