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

Universitätsklinikum Hamburg-Eppendorf

Status: Active, not recruiting

Conditions: Reduction of Intestinal Inflammatory Activity

Treatments: Dietary Supplement: Gluten-free diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05867537

miGut Health

Details and patient eligibility

About

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).

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 3 patient groups

Gluten-free diet in Crohn disease

Active Comparator group

Treatment:

Dietary Supplement: Gluten-free diet

Gluten-free diet in ulcerative colitis

Active Comparator group

Treatment:

Dietary Supplement: Gluten-free diet

Gluten-free diet in Primary sclerosing cholangitis

Active Comparator group

Treatment:

Dietary Supplement: Gluten-free diet