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NCT Number: NCT05867537

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Reduction of Intestinal Inflammatory Activity

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinikum Hamburg Eppendorf

Hamburg, 20246, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gluten-free diet

Dietary Supplement

Implementation a 78-week dietary intervention to patients with ulcerative colitis, crohn´s disease and UC patients with associated PSC (PSC-IBD).

Primary outcomes

  1. 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)

    Time frame: 78 Weeks + 12 Month follow-up

    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)

  2. 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

    Time frame: 78 Weeks + 12 Month follow-up

    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).

Secondary outcomes

  1. The efficacy and feasibility of a long-term dietary intervention to change mucosal transcripts of TNF-alpha of the intestine in IBD patients

    Time frame: 78 Weeks + 12 Month follow-up

    Changes between baseline and end of dietary period in TNF-alpha of mucosal transcript profiles.

  2. The efficacy and feasibility of a long-term dietary intervention to change mucosal transcripts of IL-10 of the intestine in IBD patients

    Time frame: 78 Weeks + 12 Month follow-up

    Changes between baseline and end of dietary period in IL-10 mucosal transcript profiles.

  3. The efficacy and feasibility of a long-term dietary intervention to change mucosal transcripts of IL-6 of the intestine in IBD patients

    Time frame: 78 Weeks + 12 Month follow-up

    Changes between baseline and end of dietary period in IL-6 mucosal transcript profiles.

  4. Long-term dietary influence on intestinal microbiome in IBD patient cohorts

    Time frame: 78 Weeks + 12 Month follow-up

    Changes between baseline and end of dietary period in luminal microbiome dynamics from faecal samples identified by 16S RNA sequencing.

Sponsors and collaborators

Lead sponsor

Universitätsklinikum Hamburg-Eppendorf

Other

Collaborators

  • Catholic University of the Sacred Heart
  • Eurice European Research and project office GMBH, Germany
  • European Federation of Crohn´s and Ulcerative Colitis Associations, Belgium
  • Lithuanian University of Health Sciences
  • Orebro University, Sweden
  • Region Capital Denmark
  • University Hospital Schleswig-Holstein
  • University Medical Center Groningen, Netherland
  • Weizmann Institute of Science, Israel

Registry information

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
May 22, 2023
Registry last updated
Mar 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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