Effect of Proton Pump Inhibitors on the Colonic Microbiome in Children
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Change in Fecal Microbiome Diversity, Assessed by Bray-Curtis Index Comparing Those Who Received Acid Suppression Medications to Those Who Received Lifestyle Modifications
研究概览
简要总结
The colonic microbiome is essential in health and disease, and is highly dynamic during the first several years of life. Proton pump inhibitors (PPIs) and histamine-2 receptor antagonists (H2RAs) are widely used in children, but the effects of PPIs and H2RAs on the pediatric colonic microbiome are unknown. This study will determine whether acid suppression with these medications affects the microbiome of otherwise healthy children who are prescribed acid suppression for gastroesophageal reflux disease (GERD), and determine the duration and magnitude of microbiome changes.
详细描述
Otherwise healthy children age 0-4 years old who are being considered for acid suppressive therapy for GERD will be eligible for this study. Subjects donate samples before and after being treated with PPIs or H2RAs (must donate at least 2 baseline pre-PPI samples to be eligible for final analysis). 30 total children who complete the study (anticipated 10 who receive lifestyle modification and 20 who receive PPIs or H2RAs). All children will donate 6 stools on or about weeks 0, 4, 12, 20, 38, and 64. The primary outcome will be a significant change in the overall diversity of the colonic microbiome after 8 weeks of PPIs or H2RAs (i.e., from week 12 to week 4), compared to after 4 weeks of lifestyle management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Zero to 4 years old
- •Being considered for PPI or H2RA treatment for refractory GERD
- •Parent is able to give informed consent
排除标准
- •Prevalent C. difficile infection (excluded via stool PCR at week 0)
- •Use of systemic antibiotics within the past 90 days
- •Use of acid suppression medications within the past 90 days (antacids allowed if none within the last 7 days)
- •Increased risk for fracture due to vitamin D deficiency or other causes
- •Chronic gastrointestinal disease (e.g. inflammatory bowel disease, celiac disease, microscopic colitis, malabsorptive conditions, short gut syndrome)
- •Congenital deficiency in immunity (e.g., such as IgA deficiency)
- •Cystic fibrosis
- •Significant dynamic or uncontrolled comorbidity such as HIV or malignancy
- •Use of medications with potential interaction with PPIs
研究组 & 干预措施
Omeprazole (suspension)
Open-label, with all subjects receiving omeprazole
干预措施: Omeprazole (suspension) (Drug)
Lifestyle Modification
Treated with lifestyle modification (upright feeding, smaller meals, elevation of the head of the bed, etc.)
干预措施: Lifestyle Modification (Other)
结局指标
主要结局
Change in Fecal Microbiome Diversity, Assessed by Bray-Curtis Index Comparing Those Who Received Acid Suppression Medications to Those Who Received Lifestyle Modifications
时间窗: From week 12 to week 4
次要结局
- Percent Subjects Eating High Fiber Diet(Up to Week 64)
研究者
Julian A Abrams, MD
Professor of Medicine and Epidemiology
Columbia University