Protease Regulation and Impact of Sodium as Mechanisms of Inflammation in IBD

NCT07169123 | Recruiting

• 1 other identifier: HiREB-18816
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 2

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

Keywords

sodium; Crohn's disease; proteases; diet

Outcome Measures

Primary Outcomes (1)

• Dietary Sodium Intake

  Dietary sodium intake will be assessed via 24-hour dietary recall and sodium-specific food frequency questionnaires (mg/day). Values will be used to classify participants as HSD or LSD and correlated with changes in proteolytic activity, mucosal permeability, and disease activity.

  Phase 1: baseline (Year 0); Year 1; and Year 2. Phase 2: baseline (Week 0); Week 1; and Week 2.

Secondary Outcomes (4)

• Proteolytic Activity in Stool and Colonic Biopsies

  Stool: Phase 1 - baseline (Year 0); Year 1; and Year 2. Biopsy: Phase 2 - Week 2

• Crohn's Disease Activity Index (CDAI)

  Phase 1: baseline (Year 0); Year 1; and Year 2. Phase 2: baseline (Week 0); and Week 2.

• Mucosal Permeability

  Phase 2: Week 2

• Patient Subgroup Characterization Based on Metabolic and Microbial Profiles

  Phase 1: baseline (Year 0); Year 1; and Year 2. Phase 2: baseline (Week 0); Week 1; and Week 2.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of Crohn's disease followed at McMaster University's Gastroenterology Outpatient Clinic.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (2)

McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

RECRUITING

McMaster University Medical Centre

Hamilton, Ontario, L8S 4L8, Canada

NOT YET RECRUITING

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Biospecimen

Retention: SAMPLES WITHOUT DNA

The following samples will be retained for analysis: blood (for sodium, CRP, and metabolomics), stool (for microbiota, metabolomics, fecal calprotectin, and proteolytic activity), and spot urine (for sodium, creatinine, potassium, and metabolomics). In Phase 2, additional fecal samples will be collected for microbiota and metabolomics analysis, along with blood and urine (for metabolomics), and colonic biopsies (for microbiota composition, metabolomics, proteolytic activity, and microbial proteases).

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• David Armstrong, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gaston H Rueda, MD

CONTACT

905 521-2100; ruedag@mcmaster.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: September 11, 2025
• Study Start: August 18, 2025
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: July 30, 2026

Record last verified: 2026-07

Locations

CA (2)