PRISM-IBDSodium Impact on Inflammation in Crohn's Disease
Data Collection
Collected from today forward - ProspectiveCrohn Disease+3
+ Digestive System Diseases
+ Gastroenteritis
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: September 18, 2025
Actual date on which the first participant was enrolled.This study explores how dietary sodium affects inflammation in people with Crohn's disease, a type of inflammatory bowel disease (IBD). The research is conducted in two phases. In the first phase, 300 individuals with Crohn's disease are monitored over two years to understand how sodium in their diet and enzymes in their stool relate to their disease activity. This information is gathered through regular health checks, questionnaires about their diet, and analysis of blood, stool, and urine samples. The goal is to create a comprehensive registry to better understand the factors that influence inflammation in Crohn's disease. In the second phase, a smaller group of 80 participants from the first phase continues with a more detailed study. These participants are divided into two groups based on their sodium intake—one high-sodium and one low-sodium. Over three weeks, they provide stool, blood, and urine samples to examine changes in gut bacteria and other metabolic markers. A colonoscopy is performed in the second week to directly observe the gut's condition. Throughout this phase, participants' diets are carefully tracked to assess the impact of sodium and other nutrients on their disease. This phase aims to provide deeper insight into how sodium consumption might influence the inflammation process in Crohn's disease.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.300 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
McMaster University Medical Centre
Hamilton, CanadaOpen McMaster University Medical Centre in Google Maps