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

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

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).

Sponsors & Collaborators

• University Medical Centre Schleswig-Holstein

  collaborator UNKNOWN

• Lithuanian University of Health Sciences

  collaborator OTHER

• University Medical Center Groningen, Netherland

  collaborator UNKNOWN

• Weizmann Institute of Science, Israel

  collaborator UNKNOWN

• Catholic University of the Sacred Heart

  collaborator OTHER

• Eurice European Research and project office GMBH, Germany

  collaborator UNKNOWN

• Orebro University, Sweden

  collaborator UNKNOWN

• Region Capital Denmark

  collaborator OTHER

• European Federation of Crohn´s and Ulcerative Colitis Associations, Belgium

  collaborator UNKNOWN

• Universitätsklinikum Hamburg-Eppendorf

  lead OTHER

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-01-18

Primary Completion

2028-01-31

Completion

2028-01-31

Countries

• Germany

Study Locations