An observational study in Post-infectious Irritable Bowel Syndrome and Irritable Bowel Syndrome, sponsored by University of Nevada, Reno. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-02.
Sponsored by University of Nevada, Reno · Observational
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.
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.
1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.
This study's enrollment of 81 is below the median of 150 across 178 observational studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →University of Nevada, Reno is the lead sponsor of 28 studies on the registry; 5 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
-None
Participants will have post-infectious IBS (as identified via Rome IV criteria or previous physician diagnosis)
Participants will not have post-infectious IBS, matched on age group, sex, and race/ethnicity.
Participants will have IBS, matched on age group, sex, and race/ethnicity.
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
Time frame: Day 1
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
Time frame: Day 1
Plan to share: Yes — 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.
Supporting information: Study protocol, Sap, Icf, Csr, Analytic code
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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University of Nevada, Reno