The Gastrointestinal Microbiome of Infants With GERD and PPI Therapy: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- microbial community profiling of stool to include: rate [or prevalence] of specific phyla [i.e. Proteobacteria and Firmicutes], contributing to fecal microbial communities
研究概览
简要总结
Proton Pump Inhibitors (PPI) are standard in the therapy of pediatric GERD. In the past it has been hypothesized, that either direct inhibition of bacterial ATPase or elevation of the pH may lead to changes in the intestinal microbiome. Small series published in adults suggest a predominance of streptococci, a possible reason for increased incidences of pneumonia under PPI therapy. Studies in children are yet scarce.
This study will include 20 infants. GERD will be verified by 24h-intraluminal impedance monitoring. All patients will have undergone conservative measures prior to initiation of PPI therapy (due to persisting symptoms). Children will receive a commercial PPI for 8 weeks (esomeprazole 1mg/kg/day). Stool samples will be collected before initiation of PPI, under PPI (4 weeks after initiation) and 8 weeks after discontinuing PPI therapy. The intestinal microbiome will be determined by 16S rDNA-based microbial community profiling by high-throughput pyrosequencing.
Data will be compared by dependent non parametric test (Wilcoxon). P-values <0.05 will be considered statistically significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •symptomatic GERD (proved by impedance monitoring) despite conservative treatment requiring PPI therapy
排除标准
- •neurological impairments
研究组 & 干预措施
Single Arm Study -microbiome
This is a single-arm study. The patients will serve as their own controls. The PPI administered for PPI-therapy is already FDA approved. A stool sample will be obtained for intestinal microbiome testing before PPI, under PPI and after PPI therapy.
干预措施: PPI therapy (Drug)
Single Arm Study -microbiome
This is a single-arm study. The patients will serve as their own controls. The PPI administered for PPI-therapy is already FDA approved. A stool sample will be obtained for intestinal microbiome testing before PPI, under PPI and after PPI therapy.
干预措施: Stool sample (Procedure)
结局指标
主要结局
microbial community profiling of stool to include: rate [or prevalence] of specific phyla [i.e. Proteobacteria and Firmicutes], contributing to fecal microbial communities
时间窗: 16 weeks
The change of intestinal microbiota under PPI therapy will be examined.
次要结局
未报告次要终点
研究者
Castellani Christoph, MD
PD Dr. med.
Medical University of Graz