Clinical trial NCT06032117: Characterizing Protein Biomarkers of Post-infection Irritable Bowel Syndrome
Official title: Characterizing Protein Biomarkers of Post-infection Irritable Bowel Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post-infectious Irritable Bowel Syndrome
Irritable Bowel Syndrome
Lead sponsor: University of Nevada, Reno
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Rome IV diagnosis of post-infectious irritable bowel syndrome
timeFrame: Day 1
Secondary outcomes:
measure: Participant-reported post-infectious irritable bowel syndrome
timeFrame: Day 1
Other outcomes:
Locations:
city: Reno
country: United States
facility: Renow Health, Mae Anne Clinic
state: Nevada
Study officials:
References: