Protease Regulation and Impact of Sodium as Mechanisms of Inflammation in IBD
Observational · No treatment assigned · 2 sites · McMaster University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Crohns Disease. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 to 70
- Any sex
Some of the main requirements, copied from the record:
- 18 and 70 years of age
- Crohn's disease diagnosis
- Willing and able to sign written informed consent prior to study entry
Plus 1 more requirement(s). There are also 4 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 300 participants are expected to take part.
- Start date: 2025-08-18.
- Main results expected around 2029-09-01 (estimate from the record).
- 2 study sites listed (1 marked recruiting) in Canada.
Main thing being measured
- Dietary Sodium Intake (Phase 1: baseline (Year 0); Year 1; and Year 2. Phase 2: baseline (Week 0); Week 1; and Week 2.)
In the researchers’ words
The study looks at how eating salt affects gut health in people with Crohn's disease. The aim of the study is to find out whether eating more salt increases the breakdown of proteins in the gut and if this makes inflammation and symptoms worse.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Crohns Disease |
| Lead sponsor | McMaster University |
| Enrollment | 300 (estimated) |
| Start date | 2025-08-18 |
| Primary completion (est.) | 2029-09-01 |
| First posted | 2025-09-11 |
| Last updated | 2026-07-30 |
| Official title | Protease Regulation and Impact of Sodium as Mechanisms of Inflammation in IBD |
| ClinicalTrials.gov ID | NCT07169123 |
Interventions
- None listed
Full eligibility criteria (from the record)
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Locations (2)
| Site | City | Country | Site status |
|---|---|---|---|
| McMaster University | Hamilton, Ontario | Canada | Recruiting |
| McMaster University Medical Centre | Hamilton, Ontario | Canada | Not yet recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.