Crohns Disease
Conditions
Keywords
sodium, Crohn's disease, proteases, diet
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.
Detailed 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.
Interventions
None listed
Sponsors
McMaster University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dietary Sodium Intake | Phase 1: baseline (Year 0); Year 1; and Year 2. Phase 2: baseline (Week 0); Week 1; and Week 2. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proteolytic Activity in Stool and Colonic Biopsies | Stool: Phase 1 - baseline (Year 0); Year 1; and Year 2. Biopsy: Phase 2 - Week 2 | Proteolytic activity will be assessed in fecal samples and colonic biopsies. Fecal samples will be analyzed for host and bacterial proteases (units of proteolytic activity per gram of stool, U/g), and colonic biopsies for host and bacterial proteases (units of proteolytic activity per mg of tissue, U/mg). Comparisons will be made between participants consuming a high-sodium diet (HSD) and a low-sodium diet (LSD) to evaluate associations with mucosal barrier dysfunction and disease activity over time. |
| Crohn's Disease Activity Index (CDAI) | Phase 1: baseline (Year 0); Year 1; and Year 2. Phase 2: baseline (Week 0); and Week 2. | Crohn's Disease Activity Index will be calculated using patient-reported symptoms, physical exam findings, and lab values (score, unitless). CDAI \<150 indicates remission, 150-220 mild disease, 220-450 moderate disease, and \>450 severe disease. CDAI scores will be compared between HSD and LSD groups to evaluate changes in clinical disease activity over time. |
| Mucosal Permeability | Phase 2: Week 2 | Colonic biopsies will be analyzed for mucosal barrier integrity using permeability assays (e.g., FITC-dextran flux). Higher values indicate greater barrier dysfunction (permeability index, arbitrary units). Comparisons will be made between HSD and LSD groups to determine effects of dietary sodium intake. |
| 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. | Participants will be characterized using dietary sodium intake, metabolic profiling (blood, urine, stool), and microbial activity (stool and biopsy-based proteolytic and microbiome analyses). Data will identify subgroups with distinct metabolic signatures, sodium intake levels, microbial profiles, and disease progression, providing insight into diet-microbiota-host metabolism interactions in Crohn's disease. |
Countries
Canada
Contacts
CONTACTGaston H Rueda, MD
PRINCIPAL_INVESTIGATORDavid Armstrong, MD
McMaster University
Outcome results
None listed