Salt and Crohn’s disease: how salt in the diet relates to inflammation
Official title: Protease Regulation and Impact of Sodium as Mechanisms of Inflammation in IBD
Run by McMaster University · NCT07169123 · Data updated 2026-11-12
This study tests whether higher salt intake affects gut inflammation and symptoms in people with Crohn’s disease.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | McMaster University Academic / other |
| Locations | 2 sites (Hamilton, Ontario and 1 other locations) |
| Status | Recruiting |
| Started | August 18, 2025 |
| Main results expected | September 1, 2029 |
| Study ends | September 1, 2029 |
| Registry record updated | July 30, 2026 |
| Trial ID | NCT07169123 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with Crohn’s disease who can comply with long-term follow-up and sample collection.
✕Probably not a fit
Patients who cannot comply with follow-up visits, have recent antibiotic or probiotic use, or have other factors that could confound results may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study follows adults with Crohn’s disease to see how dietary sodium relates to disease activity, gut proteolytic activity, and the gut microbiome over time. Phase 1 enrolls 300 participants to track diet, lab measures, and disease activity for two years, creating a registry. Phase 2 selects 80 participants to compare high- and low-sodium diets over two weeks with paired samples and a colonoscopy to examine tissue changes. The study uses dietary recalls, urine and blood tests, stool analyses, and metagenomic/metabolomic profiling to explore links between salt, microbiota, proteolysis, and inflammation.
Why it matters
Potential benefit: If successful, findings could inform personalized dietary guidance for people with Crohn’s disease to help manage inflammation.
How similar studies have gone: Previous work has explored diet and inflammation in Crohn’s disease, but this study’s focus on salt-specific effects and proteolytic activity is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
McMaster University
Hamilton, Ontario, Canada Recruiting -
McMaster University Medical Centre
Hamilton, Ontario, Canada Not yet recruiting
Study contacts
- Principal investigator: David Armstrong, MD — McMaster University
- Study coordinator: Gaston H Rueda, MD
- Email: ruedag@mcmaster.ca
- Phone: 905 521-2100
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.