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

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

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).

Inclusion Criteria:

• Confirmed diagnosis of UC, CD or PSC-IBD
• Willingness, to follow a gluten-free diet for 78 weeks
• Stable therapeutic treatment for more 8 weeks
• For CD: Harvey Bradshaw index (HBI) of more 5 points, corresponding to a minimum of mild intestinal inflammation in CD
• For UC: Mayo Score of more 2 points, corresponding to a minimum of mild intestinal inflammation in UC
• Patient signed informed consent

Exclusion Criteria:

• Antibiotics during last 4 weeks
• Intake of probiotics
• Gluten-free diet is already practiced
• Concomitant diagnosis of celiac disease
• Positive serology for transglutaminase IgA / IgG antibody or deamidated gliadin IgA / IgG
• Breast feeding
• Pregnancy