Characterizing Protein Biomarkers of Post-infection Irritable Bowel Syndrome

NCT ID: NCT06032117

Last Updated: 2025-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

81 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-11

Study Completion Date

2024-12-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Post-infectious Irritable Bowel Syndrome Irritable Bowel Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Post infectious irritable bowel syndrome group

Participants will have post-infectious IBS (as identified via Rome IV criteria or previous physician diagnosis)

No interventions assigned to this group

Healthy control group

Participants will not have post-infectious IBS, matched on age group, sex, and race/ethnicity.

No interventions assigned to this group

Irritable bowel syndrome group

Participants will have IBS, matched on age group, sex, and race/ethnicity.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Nevada, Reno

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Renow Health, Mae Anne Clinic

Reno, Nevada, United States

Site Status

Countries

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United States

Other Identifiers

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1891300

Identifier Type: -

Identifier Source: org_study_id

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