Protease Regulation and Impact of Sodium as Mechanisms of Inflammation in IBD
NCT ID: NCT07169123
Last Updated: 2025-09-11
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
NOT_YET_RECRUITING
Total Enrollment
300 participants
Study Classification
OBSERVATIONAL
Study Start Date
2025-09-18
Study Completion Date
2029-09-01
Brief Summary
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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.
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Detailed Description
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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.
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.
Conditions
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Crohns Disease
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
70 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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McMaster University
OTHER
Sponsor Role
lead
Responsible Party
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David Armstrong
Principal Investigator
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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David Armstrong, MD
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Locations
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McMaster University Medical Centre
Hamilton, Ontario, Canada
Site Status
Countries
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Canada
Central Contacts
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Facility Contacts
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Other Identifiers
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HiREB-18816
Identifier Type: -
Identifier Source: org_study_id
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