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NCT06032117 · ClinicalTrials.gov registry record
Characterizing Protein Biomarkers of Post-infection Irritable Bowel Syndrome
A clinical trial, sponsored by University of Nevada, Reno.
- Completed
- Registry status
- 81
- Enrollment target
NCT06032117: Completed study, sponsored by University of Nevada, Reno.
NCT06032117 is a clinical trial that has completed, run by University of Nevada, Reno. The registered enrollment target is 81 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06032117 has completed, sponsored by University of Nevada, Reno.
- COMPLETED
- Registry status
- 81 participants
- Enrollment target
Study 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.
Primary Outcome
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
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2024-04-11 |
| Est. Completion | 2024-12-30 |
What the finished NCT06032117 record still lists
NCT06032117 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 81 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT06032117 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06032117 about?
NCT06032117 is a clinical study titled "Characterizing Protein Biomarkers of Post-infection Irritable Bowel Syndrome". 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 te...
What is the current status of trial NCT06032117?
This trial is currently completed. The enrollment target is 81 participants. The study started on 2024-04-11. Estimated completion is 2024-12-30.
Who is sponsoring clinical trial NCT06032117?
This trial is sponsored by University of Nevada, Reno, which has 23 total clinical trials registered on ClinicalTrials.gov.
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