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临床试验/NCT03747991
NCT03747991已完成不适用

Effect of Histamine-2 Receptor Antagonists on the Microbiome of Full Term Infants

Nemours Children's Clinic1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2018年8月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
1
主要终点
Microbiome taxa

研究概览

简要总结

The changes in the organisms making up the gut microbiota in infants who are taking anti-acid reflux medications (histamine 2 receptor antagonists) as compared to infants who are not taking these medications is not well-studied or understood. Whether these medications change the gut microbiota and microbiome, and what that change may imply for children on these medications, is the focus of this study.

详细描述

Gut microbiota dysbiosis is associated with diseases ranging from localized gastrointestinal disorders to neurologic, respiratory, metabolic, hepatic, and cardiovascular illnesses. The microbial colonization of the infant gut is known to play a key role in immunologic and metabolic pathways impacting on human health. Disruptions during the complex process of microbial colonization have been shown to increase disease susceptibility during life. A variety of factors are known to influence the gut microbiota, including mode of delivery of neonate, host genetic factors, hose immune response, diet, xenobiotics and other drugs, infections, and environmental microbial exposures.

The diagnosis of gastroesophageal reflux disease in the infant population has increased during the past two decades. Acid suppression medications are used commonly in infants for gastroesophageal reflux disease and other acid-related conditions despite little evidence of their efficacy. Multiple studies have shown adverse effects in pediatric patients using either proton pump inhibitors or H2 receptor antagonists, the two classes of acid suppression medications that are most frequently used in children. Some of these adverse effects may result from alterations in the microbiome caused by these medications. Prior studies have demonstrated significant changes in microbial composition of both gastric and intestinal microbiota with proton pump inhibitor use (5), but to the investigators' knowledge, no prior studies have looked at the effect of H2 receptor antagonists on the microbiome in healthy, full term infants.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
2 Months 至 12 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Full term, at least 2 months of age
  • No exposure OR at least 14 days of exposure to H2-receptor antagonist medication
  • No exposure to probiotics or antibiotics

排除标准

  • Current or recent (within the past 14 days) gastrointestinal infection (viral, bacterial, or fungal)
  • Gastrointestinal mucosal disease, or have clinically significant constipation
  • Any history of exposure to proton pump inhibitors
  • Unvaccinated infants
  • Infants with weight-for-length either below the 3rd percentile for age or above the 97th percentile for age
  • Infants with rapid weight gain, defined as change in weight-for-length z-score exceeding +0.67 from birth to 4 months of age or birth to 6 months of age

结局指标

主要结局

Microbiome taxa

时间窗: At time of sampling - once at enrollment

16S Metagenomic taxonomy of gut microbiome

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

Matthew Di Guglielmo

Chief, Division of General Academic Pediatrics

Nemours Children's Clinic

研究点 (1)

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