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).

Study Overview

• Status: Active, not recruiting
• Conditions: Reduction of Intestinal Inflammatory Activity
• Intervention / Treatment: Dietary supplement: Gluten-free diet

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20246
    • Universitatsklinikum Hamburg Eppendorf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Gluten-free diet in Crohn disease	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).
Active Comparator: Gluten-free diet in ulcerative colitis	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).
Active Comparator: Gluten-free diet in Primary sclerosing cholangitis	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in clinical and endoscopic parameters of intestinal inflammation following 78 weeks of long-term gluten free dietary intervention, compared to pre-interventional levels in crohn´s disease (CD)	Change of Harvey bradshaw index (HBI) for CD following 78 weeks of long-term gluten free dietary intervention. HBI range from 0 to 18 points + number of daily liquid stools (remission: HBI < 5, active disease: HBI ≥ 5, severe disease: HBI ≥ 8)	78 Weeks + 12 Month follow-up
Change in clinical and endoscopic parameters of intestinal inflammation following 78 weeks of long-term gluten free dietary intervention, compared to pre-interventional levels in ulcerative colitis (UC) and PSC-IBD	Change of partial Mayo Score (pMS) for UC and PSC-IBD following 78 weeks of long-term gluten free dietary intervention. pMS range from 0 to 12 points (remission: pMS < 2, mild activity: pMS 2-4, moderate activity: pMS 5-7, severe activity: pMS > 7).	78 Weeks + 12 Month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The efficacy and feasibility of a long-term dietary intervention to change mucosal transcripts of TNF-alpha of the intestine in IBD patients	Changes between baseline and end of dietary period in TNF-alpha of mucosal transcript profiles.	78 Weeks + 12 Month follow-up
The efficacy and feasibility of a long-term dietary intervention to change mucosal transcripts of IL-10 of the intestine in IBD patients	Changes between baseline and end of dietary period in IL-10 mucosal transcript profiles.	78 Weeks + 12 Month follow-up
The efficacy and feasibility of a long-term dietary intervention to change mucosal transcripts of IL-6 of the intestine in IBD patients	Changes between baseline and end of dietary period in IL-6 mucosal transcript profiles.	78 Weeks + 12 Month follow-up
Long-term dietary influence on intestinal microbiome in IBD patient cohorts	Changes between baseline and end of dietary period in luminal microbiome dynamics from faecal samples identified by 16S RNA sequencing.	78 Weeks + 12 Month follow-up

Collaborators and Investigators

• Sponsor: Universitätsklinikum Hamburg-Eppendorf
• Collaborators: Lithuanian University of Health Sciences; Catholic University of the Sacred Heart; Örebro University, Sweden; University Medical Centre Schleswig-Holstein; University Medical Center Groningen, Netherland; Weizmann Institute of Science, Israel; Eurice European Research and project office GMBH, Germany; Region Hovedstaden, Denmark; European Federation of Crohn´s and Ulcerative Colitis Associations, Belgium

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2023
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: April 3, 2023
• First Submitted That Met QC Criteria: May 10, 2023
• First Posted (Actual): May 22, 2023

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 25, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: IBD; PSC
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: miGut Health

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No