Characterizing Protein Biomarkers of Post-infection Irritable Bowel Syndrome

NCT06032117 | Completed

• 1 other identifier: 1891300
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-infectious Irritable Bowel Syndrome; Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Participant-reported post-infectious irritable bowel syndrome

  Day 1

Study Arms (3)

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.

Irritable bowel syndrome group

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• University of Nevada, Reno: lead

Study Sites (1)

Renow Health, Mae Anne Clinic

Reno, Nevada, 89523, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Approximately 6 ml of blood will be collected from each participant. Samples will be centrifuged (1,000-2,000 x g for 10 minutes), the serum separated and placed into an Eppendorf tube/cryovials, and stored in a -80 °C fridge until analysis. The proteomics lab will use 100ul of serum, and the rest will be banked in cryovials. The de-identified samples will be stored in a fridge at UNR, which is in a locked room and accessible only to the University of Nevada, Reno (UNR) research team. The researchers will not identify these samples or perform identifying tests (e.g., genetics tests) on those samples. The samples will be stored for a period of 3 years.

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: September 11, 2023
• Study Start: April 11, 2024
• Primary Completion: December 19, 2024
• Study Completion: December 30, 2024
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

US (1)