Characterizing Protein Biomarkers of Post-infection Irritable Bowel Syndrome

• Sponsor: University of Nevada, Reno (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT06032117
• Collaborator: (none)
• Enrollment: 120
• Anticipated Duration (Months): 8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post-infectious Irritable Bowel Syndrome; 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 Design

• Study Type: Observational
• Anticipated Enrollment: 120 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Characterizing Protein Biomarkers of Post-infection Irritable Bowel Syndrome
• Anticipated Study Start Date: Nov 1, 2023
• Anticipated Primary Completion Date: Jun 30, 2024
• Anticipated Study Completion Date: Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Rome IV diagnosis of post-infectious irritable bowel syndrome [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

Secondary Outcome Measures

1. Participant-reported post-infectious irritable bowel syndrome [Day 1]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Participants must have a Healthy Nevada Project record and linked Renown Health medical record

• Must be at least 18 years of age

• Must have previously consented to being contacted and have updated contact information

Exclusion Criteria:

-None

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Nevada, Reno

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Nevada, Reno
• ClinicalTrials.gov Identifier: NCT06032117
• Other Study ID Numbers: 1891300
• First Posted: Sep 11, 2023
• Last Update Posted: Sep 11, 2023
• Last Verified: Sep 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Irritable Bowel Syndrome; Syndrome

Study Results

No Results Posted as of Sep 11, 2023