NCT05867537

Proof of Concept Human Study: Dietary Intervention to Modify Intestinal Inflammation in IBD

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Universitätsklinikum Hamburg-Eppendorf · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The objective of this clinical study is to demonstrate efficacy and feasibility of a long-term dietary intervention to modify intestinal inflammation in high-risk patient cohorts. To this end a 78 weeks wheat protein-free diet will be administered in patients with inflammatory bowel disease (IBD) with and without associated primary sclerosing cholangitis (PSC-IBD).

Conditions

• Reduction of Intestinal Inflammatory Activity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Gluten-free diet	Implementation a 78-week dietary intervention to patients with ulcerative colitis, crohn´s disease and UC patients with associated PSC (PSC-IBD).

Timeline

• Start date: 2023-01-18
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2023-05-22
• Last updated: 2025-03-30

Locations

1 site across 1 country: Germany