Protease Regulation and Impact of Sodium as Mechanisms of Inflammation in IBD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Dietary Sodium Intake
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Dietary Sodium Intake
时间窗: 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.
次要结局
- 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.)
研究者
David Armstrong
Principal Investigator
McMaster University