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Characterizing Protein Biomarkers of Post-infection Irritable Bowel Syndrome

U

University of Nevada, Reno

Status

Completed

Conditions

Irritable Bowel Syndrome
Post-infectious Irritable Bowel Syndrome

Study type

Observational

Funder types

Other

Identifiers

NCT06032117
1891300

Details and patient eligibility

About

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.

Full description

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.

Enrollment

81 patients

Sex

All

Ages

18 to 100 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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

Exclusion criteria

-None

Trial design

81 participants in 3 patient groups

Post infectious irritable bowel syndrome group
Description:
Participants will have post-infectious IBS (as identified via Rome IV criteria or previous physician diagnosis)
Healthy control group
Description:
Participants will not have post-infectious IBS, matched on age group, sex, and race/ethnicity.
Irritable bowel syndrome group
Description:
Participants will have IBS, matched on age group, sex, and race/ethnicity.

Trial contacts and locations

1

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Central trial contact

Joshua Garn, PhD

Data sourced from clinicaltrials.gov

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