Protease Regulation and Impact of Sodium as Mechanisms of Inflammation in IBD (PRISM-IBD)

McMaster University

Status: Not yet enrolling

Conditions: Crohns Disease

Study type: Observational

Funder types: Other

Identifiers

NCT07169123

HiREB-18816

Details and patient eligibility

About

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.

Full description

This longitudinal exploratory study has two related phases:

Phase 1 will enroll 300 Crohn's disease (CD) patients from McMaster's IBD and IBD Nutrition Clinics to assess dietary sodium intake and fecal proteolytic activity in relation to disease activity (active/inactive). Participants will be followed annually for 2 years, forming a registry. At baseline and each follow-up visit, data collected will include: demographics, BMI, CDAI, diet (1-week food recall via Keenoa and 6-month sodium questionnaire), blood (sodium, metabolomics, CRP), stool (microbiota, metabolomics, fecal calprotectin, proteolytic activity), and spot urine (sodium, potassium, creatinine, metabolomics). Extra visits will occur if a disease flare happens.

Phase 2 will involve 80 participants from Phase 1 (40 high-sodium diet [HSD], 40 low-sodium diet [LSD]), selected based on sodium intake. Over three visits (baseline, week 1, week 2), participants will provide fecal samples for microbiota and metabolomics analysis, and blood/urine samples (baseline and week 2). Colonoscopy with biopsies and video will be performed at week 2. Diet will be closely tracked using Keenoa to assess intake of sodium, carbs, UPF, fibre, and calories. After Phase 2, participants return to Phase 1 follow-up.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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