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临床试验/NCT02650245
NCT02650245已完成不适用

Breath and Blood Ammonia Response to an Oral Protein Challenge

St. Luke's Hospital and Health Network, Pennsylvania2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2015年10月1日最近更新:
适应症

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
2
主要终点
Levels of Ammonia (parts per billion) in response to an oral protein challenge using the Bedfont breath monitor

研究概览

简要总结

The investigators specific aim is to evaluate the changes in breath ammonia in comparison to blood ammonia and other physiologic markers after a moderate oral protein challenge in healthy subjects and subjects with liver cirrhosis.

详细描述

Ammonia is an important molecule relevant to numerous diseases, especially to the millions of patients with cirrhosis worldwide. Venous blood ammonia via limb phlebotomy, can at best roughly estimate whole body ammonia, but says little or nothing about intestinal production, and cannot "source" ammonia to any particular organ or body compartment. Unfortunately, there are no presently available better tests. Therefore, despite these acknowledged limitations, venous ammonia the "bronze standard" benchmark by which new metrics are assessed.

The present protocol attempts to address both concerns and build upon the investigators prior high protein experience. By using a standard moderate protein challenge, the investigators can evaluate the breath ammonia responsiveness in healthy subjects and those with cirrhosis. This protocol leverages the power of breath research to evaluate responses to oral challenges. This remains a key asset of breath research.

Since the protocol proposes a moderate protein challenge, the investigators can evaluate disease states with minimal or no risk. As with past high protein studies, lactulose (10gm) will still be added to provoke a hydrogen response.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • <18 and <75 yrs of age

排除标准

  • Diabetic, smoker, substance abuse

结局指标

主要结局

Levels of Ammonia (parts per billion) in response to an oral protein challenge using the Bedfont breath monitor

时间窗: 5 hours

Evaluating change in breath ammonia at hour 5 compared to baseline

次要结局

未报告次要终点

研究者

发起方
St. Luke's Hospital and Health Network, Pennsylvania
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Steve Solga

M.D.

St. Luke's Hospital and Health Network, Pennsylvania

研究点 (2)

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