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临床试验/NCT06032117
NCT06032117已完成不适用

Characterizing Protein Biomarkers of Post-infection Irritable Bowel Syndrome

University of Nevada, Reno1 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2024年4月11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
81
试验地点
1
主要终点
Rome IV diagnosis of post-infectious irritable bowel syndrome

研究概览

简要总结

The investigators will characterize and compare protein signatures between groups with and without post-infection irritable bowel syndrome (PI-IBS). From previous Healthy Nevada Project (HNP) participants, at least 60 patients with PI-IBS and 60 healthy controls will undergo additional proteomics testing, age, sex and race/ethnicity-matched healthy. The investigators will use proteomic testing to detect, quantify and characterize serum protein biomarkers and protein signatures, and compare biomarkers and signatures between the patient groups of interest. Serum samples will be analyzed by the Nevada Proteomics Center. Samples will first undergo protein digestion, then peptides are separated using liquid chromatography (LC), mass spectral analysis is performed using an Orbitrap Eclipse mass spectrometer (Thermo Scientific, San Jose, CA) using data-independent acquisition (DIA). Library generation and data analysis will be performed using Spectronaut software (Biognosys, Schlieren, Switzerland). The Nevada Proteomics Center and Bioinformatics Center will be engaged during the data analyses comparing biomarkers and signatures between the patient groups of interest. This research aim has the potential to add to our understanding of the underlying mechanisms of PI-IBS and to create reliable differentiating protein biomarkers to better diagnose PI-IBS.

详细描述

The investigators will characterize and compare protein signatures between groups with and without PI-IBS. From previous HNP participants, at least 60 patients with PI-IBS and 60 healthy controls will be recruited to undergo additional proteomics testing, age, sex and race/ethnicity-matched healthy. The investigators will use proteomic testing to detect, quantify and characterize serum protein biomarkers and protein signatures, and compare biomarkers and signatures between the patient groups of interest. Serum samples will be analyzed by the Nevada Proteomics Center. Samples will first undergo protein digestion, then peptides are separated using liquid chromatography (LC), mass spectral analysis is performed using an Orbitrap Eclipse mass spectrometer (Thermo Scientific, San Jose, CA) using data-independent acquisition (DIA). Library generation and data analysis will be performed using Spectronaut software (Biognosys, Schlieren, Switzerland). The Nevada Proteomics Center and Bioinformatics Center will be engaged during the data analyses comparing biomarkers and signatures between the patient groups of interest. This research aim has the potential to add to our understanding of the underlying mechanisms of PI-IBS and to create reliable differentiating protein biomarkers to better diagnose PI-IBS.

研究设计

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

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants must have a Healthy Nevada Project record and linked Renown Health medical record
  • Must be between 18 and 89 years of age
  • Must have previously consented to being contacted and have updated contact information

排除标准

  • 未提供

结局指标

主要结局

Rome IV diagnosis of post-infectious irritable bowel syndrome

时间窗: Day 1

Rome IV is used to diagnose IBS, and participants must additionally have had sudden onset of their IBS with either 1) IBS symptoms developing immediately AFTER foreign travel/deployment or 2) immediately AFTER acute infectious gastroenteritis with two or more of: fever, vomiting, diarrhea

次要结局

  • Participant-reported post-infectious irritable bowel syndrome(Day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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