Characterizing Protein Biomarkers of Post-infection Irritable Bowel Syndrome

Irritable Bowel Syndrome Clinical Trial

Official title:

Characterizing Protein Biomarkers of Post-infection Irritable Bowel Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06032117
• Other study ID #: 1891300
• Status: Recruiting
• Start date: April 11, 2024
• Est. completion date: June 30, 2024

Study information

• Verified date: April 2024
• Source: University of Nevada, Reno
• Contact: Joshua Garn, PhD
• Phone: (775) 682-6996
• Email: jgarn[@]unr.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Locations

Country	Name	City	State
United States	Renow Health, Mae Anne Clinic	Reno	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
University of Nevada, Reno

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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