Recruiting soon

PRISM-IBDSodium Impact on Inflammation in Crohn's Disease

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What is being collected

Data Collection

Collected from today forward - Prospective
No DNA Sample
Who is being recruted

Crohn Disease+3

+ Digestive System Diseases

+ Gastroenteritis

From 18 to 70 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: September 2025
See protocol details

Summary

Principal SponsorMcMaster University
Study ContactGaston H Rueda, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleProtease Regulation and Impact of Sodium as Mechanisms of Inflammation in IBD
NCT07169123
Principal SponsorMcMaster University
Study ContactGaston H Rueda, MD
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

300 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Crohn DiseaseDigestive System DiseasesGastroenteritisGastrointestinal DiseasesIntestinal DiseasesInflammatory Bowel Diseases

Criteria

4 inclusion criteria required to participate
18 and 70 years of age

Crohn's disease diagnosis

Willing and able to sign written informed consent prior to study entry

Able to comply with the study procedures, in the opinion of the investigator

4 exclusion criteria prevent from participating
Antibiotics, antibacterial agents, or probiotics, currently, or within the last 8 weeks

Alcohol or drug abuse

Pregnancy

Concurrent systemic disease and/or laboratory abnormalities considered by investigators to be a risk or that could interfere with data collection

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

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

Suspended

McMaster University Medical Centre

Hamilton, CanadaOpen McMaster University Medical Centre in Google Maps
Recruiting soonOne Study Center