Characterizing Protein Biomarkers of Post-infection Irritable Bowel Syndrome

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.

Study Overview

• Status: Recruiting
• Conditions: Irritable Bowel Syndrome; Post-infectious Irritable Bowel Syndrome

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Joshua Garn, PhD; Phone Number: (775) 682-6996; Email: jgarn@unr.edu

Study Locations

• United States
  • Nevada
    • Reno, Nevada, United States, 89523
      • Recruiting
      • Renow Health, Mae Anne Clinic
      • Contact: Savanna Grime; Email: savanna.grime@renown.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

To approximate the population of Washoe county in our recruitment survey we will use a stratified random sampling scheme to randomly sample from strata of sex and ethnicity from within the HNP, so that our study sample is approximately 50% male and 50% female, and approximately 24.5% Hispanic. From these survey responses, the PI will be able to find 60 PI-IBS cases, and 60 controls. We will send the recruitment email to additional participants following the same methods described above (e.g., batching 1000 potential participants at a time, oversampling Hispanics and women in the same way) until we have found 60 total PI-IBS participants. If we have further difficulties finding PI-IBS participants, we may send targeted emails to previous HNP participants who has an ICD 10 code indicating a gastrointestinal infection or IBS in the last 5 years.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rome IV diagnosis of post-infectious irritable bowel syndrome	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	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant-reported post-infectious irritable bowel syndrome	Participants report that they have been diagnosed with IBS by a physician and that they still have symptoms, 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	Day 1

Collaborators and Investigators

• Sponsor: University of Nevada, Reno

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2024
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: July 28, 2023
• First Submitted That Met QC Criteria: September 7, 2023
• First Posted (Actual): September 11, 2023

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 19, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome
• Other Study ID Numbers: 1891300

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Final study results will be posted to ClinicalTrials.gov within 12 months of study completion.

The study protocol and statistical analysis plans will be shared on Open Science Framework (OSF) before the first biological samples are collected.

The informed consent form will be posted to OSF within 60 days of the last study visit by any participant.

Analytic code and relevant data will be posted to OSF upon publication of study results.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No