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Effects of Gluten Free Diet in Ulcerative Colitis

NCT06249763 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-01-12

No results posted yet for this study

Summary

The goal is to evaluate gastrointestinal symptoms and fatigue levels during a period of eating gluten free compared to a period of high gluten consumption in individuals with confirmed Ulcerative Colitis, and to identify clinical characteristics in the blood and microbiome of those improving from a gluten free diet. The main questions, the project aims to answer are:

* What is the effect of eating gluten free on patient-reported gastrointestinal symptoms in patients with Ulcerative Colitis?
* What is the effect of eating gluten free on patient-reported fatigue levels in patients with Ulcerative Colitis?
* What are clinical differences between those improving and not improving on fatigue levels and gastrointestinal symptoms?

During two study periods of one week each, participants will be eating gluten free supplemented with daily granola bars without and with high gluten content, respectively. During each active week, participants are asked to:

* Eat gluten free and two daily granola bars delivered by the research team
* Collect blood, stool and urine samples
* Answer questionnaires about their symptoms, disease course, habitual lifestyle, and compliance to the protocol

Conditions

Interventions

DIETARY_SUPPLEMENT

High gluten diet

Trial period A: gluten free diet added daily granola bars with 10 g gluten/day (intervention).

DIETARY_SUPPLEMENT

Gluten free diet

Trial period B: gluten free diet added daily granola bars with \<1 g gluten/day (placebo).

Sponsors & Collaborators

  • Odense University Hospital

    collaborator OTHER

  • Colitis-Crohn Foreningen

    collaborator OTHER

  • Hospital of Southern Jutland

    collaborator OTHER

  • University Hospital Bispebjerg and Frederiksberg

    collaborator OTHER

  • University of Southern Denmark

    lead OTHER

Principal Investigators

  • Vibeke Andersen, Prof · University of Southern Denmark

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-11
Primary Completion
2024-10-30
Completion
2024-10-30

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06249763 on ClinicalTrials.gov