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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Dietary Sodium Intake [Срок оценки: Phase 1: baseline (Year 0); Year 1; and Year 2. Phase 2: baseline (Week 0); Week 1; and Week 2.]

Вторичные конечные точки (4)

• Proteolytic Activity in Stool and Colonic Biopsies [Срок оценки: Stool: Phase 1 - baseline (Year 0); Year 1; and Year 2. Biopsy: Phase 2 - Week 2]
• Crohn's Disease Activity Index (CDAI) [Срок оценки: Phase 1: baseline (Year 0); Year 1; and Year 2. Phase 2: baseline (Week 0); and Week 2.]
• Mucosal Permeability [Срок оценки: Phase 2: Week 2]
• Patient Subgroup Characterization Based on Metabolic and Microbial Profiles [Срок оценки: Phase 1: baseline (Year 0); Year 1; and Year 2. Phase 2: baseline (Week 0); Week 1; and Week 2.]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Канада · 2 центра

• McMaster University — Hamilton
• McMaster University Medical Centre — Hamilton

Публикации

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• Buchfink B, Xie C, Huson DH. Fast and sensitive protein alignment using DIAMOND. Nat Methods. 2015 Jan;12(1):59-60. doi: 10.1038/nmeth.3176. Epub 2014 Nov 17. PMID 25402007
• Bushnell B, Rood J, Singer E. BBMerge - Accurate paired shotgun read merging via overlap. PLoS One. 2017 Oct 26;12(10):e0185056. doi: 10.1371/journal.pone.0185056. eCollection 2017. PMID 29073143
• Kopylova E, Noe L, Touzet H. SortMeRNA: fast and accurate filtering of ribosomal RNAs in metatranscriptomic data. Bioinformatics. 2012 Dec 15;28(24):3211-7. doi: 10.1093/bioinformatics/bts611. Epub 2012 Oct 15. PMID 23071270

Идентификаторы

NCT: NCT07169123 · HiREB-18816

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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