Recruiting

Salt & Gut Health

Sponsor:

McMaster University

Code:

NCT07169123

Conditions

Crohns Disease

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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. By studying the link between salt, gut bacteria and inflammation, the study hopes to improve diet advice for people with Crohn's disease. This research may help find specific foods that affect the disease and lead to better, more personalized nutrition plans.

Conditions

Crohns Disease

Study ID

NCT07169123

Start date

Aug 18, 2025

Status verified date

Jul, 2026

Completion date

Sep 1, 2029

Anticipated

Primary completion date

Sep 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Dietary Sodium Intake [ Time Frame: Phase 1: baseline (Year 0); Year 1; and Year 2. Phase 2: baseline (Week 0); Week 1; and Week 2. ]

Central Contacts and Locations

Central contacts

Gaston H Rueda, MD

905 521-2100ruedag@mcmaster.ca

Locations

McMaster University

Recruiting

Hamilton, Ontario, Canada, L8N 3Z5

Contacts

David Armstrong MD, MD

905 521 2100armstro@mcmaster.ca

More Information

Sponsor

McMaster University

Last update posted

Jul 30, 2026

Last verified

Jul, 2026

Keywords

  • sodium
  • Crohn's disease
  • proteases
  • diet

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2026-07-30.