Study of Salt Intake Effects on Gut Inflammation and Protein Activity in People with Crohns Disease

What this Trial Is About

Researchers are investigating how salt intake affects gut health in people with Crohns disease. The study aims to understand whether consuming more salt increases the breakdown of proteins in the gut and if this worsens inflammation and symptoms. By exploring the connection between salt, gut bacteria, and inflammation, the research hopes to improve dietary advice and develop more personalized nutrition plans for those with Crohns disease. The study has two phases. Phase 1 will enroll 300 participants with Crohns disease to assess their sodium intake and gut protein activity over two years, including annual follow-ups and extra visits during disease flare-ups. Phase 2 will include 80 participants from Phase 1 divided into high-sodium and low-sodium diet groups. These participants will undergo more detailed testing over three visits, including stool, blood, and urine samples, and a colonoscopy with biopsies at week 2. After Phase 2, participants return to Phase 1 follow-up. Participants will provide various samples and data such as diet recalls, blood tests, stool analysis, and urine tests at baseline and follow-ups. The study will monitor dietary sodium intake, proteolytic activity in stool and biopsies, disease activity scores, mucosal permeability, and microbial and metabolic profiles. This observational study spans up to four years, with careful tracking of diet and health to understand how salt impacts Crohns disease progression and inflammation.

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