NCT05867537

Brief 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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
20mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress67%
Jan 2023Jan 2028

Study Start

First participant enrolled

January 18, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 22, 2023

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

March 30, 2025

Status Verified

December 1, 2024

Enrollment Period

5 years

First QC Date

April 3, 2023

Last Update Submit

March 25, 2025

Conditions

Reduction of Intestinal Inflammatory Activity

Keywords

IBDPSC

Outcome Measures

Primary Outcomes (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 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 Outcomes (4)

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

    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

    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

    78 Weeks + 12 Month follow-up

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

    78 Weeks + 12 Month follow-up

Study Arms (3)

Gluten-free diet in Crohn disease

ACTIVE COMPARATOR
Dietary Supplement: Gluten-free diet

Gluten-free diet in ulcerative colitis

ACTIVE COMPARATOR
Dietary Supplement: Gluten-free diet

Gluten-free diet in Primary sclerosing cholangitis

ACTIVE COMPARATOR
Dietary Supplement: Gluten-free diet

Interventions

Gluten-free dietDIETARY_SUPPLEMENT

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

Gluten-free diet in Crohn diseaseGluten-free diet in Primary sclerosing cholangitisGluten-free diet in ulcerative colitis

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum Hamburg Eppendorf

Hamburg, 20246, Germany

Location

MeSH Terms

Interventions

Diet, Gluten-Free

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of the I. Department of Medicine, Prof. Dr. med.

Study Record Dates

First Submitted

April 3, 2023

First Posted

May 22, 2023

Study Start

January 18, 2023

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Last Updated

March 30, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)