跳至主要内容
临床试验/NCT05547360
NCT05547360招募中不适用

Analysis of Metabolomics of Blood Degradation/Digestion Using in Vitro Digestion Model to Identify Potential Biomarkers of Gastrointestinal Bleeding

National University of Singapore1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2022年7月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
32
试验地点
1
主要终点
blood metabolites

研究概览

简要总结

Despite advances in gastrointestinal endoscopy and pharmaceuticals, gastrointestinal bleeding is still a significant emergency disease with a high mortality rate of 1.9-5 per 100 people due to excessive bleeding and shock.

There are several indicators using pulse rate, blood pressure, hemoglobin, etc. to select patients who require endoscopic intervention, or hospitalization, but these are inaccurate and with a high false-positive rate and low specificity at 35-40%.

Therefore, tests with high diagnostic accuracy for gastrointestinal bleeding patients are required and findings specific biomarkers for gastrointestinal bleeding are of great importance.

详细描述

Recently, with the development of metabolomics, efforts are being made to improve the diagnosis and treatment of diseases through metabolomics analysis, but there are no studies related to gastrointestinal bleeding. If the degradation/metabolism process of blood that accumulates in the gastrointestinal tract is well studied and understood, there is a possibility of finding specific biomarkers for gastrointestinal bleeding.

Thus, this study aims to analysis of metabolomics of blood degradation/digestion using in vitro digestion model to identify potential biomarkers of gastrointestinal bleeding.

研究设计

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

入排标准

年龄范围
21 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female participants, aged between 21 and 55 years old.
  • A body mass index (BMI) between 18.5 and 29.9 kilograms per meter square.
  • English-literate and able to give informed consent in English.

排除标准

  • Clinically significant allergic, renal, cardiac, bronchopulmonary, vascular, gastrointestinal, neurological, metabolic or immunodeficiency disorders, cancer, hepatitis, or cirrhosis.
  • Had surgery of the gastrointestinal tract or any other medical condition considered likely to affect the gastrointestinal absorption.
  • Use of oral iron supplement within the past 30 days.
  • Consumes more than 2 alcoholic drinks per day i.e. one drink is defined as either 150ml of wine, 340ml of beer/cider or 45ml of distilled spirit.
  • Significant change in weight (≥ 3 kg body weight) in the past 3 months.
  • Significant exercise pattern over the past 3 months defined as high-intensity exercise of more than 3 hours per week.
  • Poor peripheral venous access based on past experiences with blood draw

结局指标

主要结局

blood metabolites

时间窗: through study completion, an average of 5 months

screening of blood metabolites in digested blood (qualitative measure, untargeted analysis, using LC-qtof-MS and GC-MS)

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

Jung Eun Kim

Assistant professor

National University of Singapore

研究点 (1)

Loading locations...

相似试验

Analysis of Blood Metabolomics to Identify Potential... | 临床试验