Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06719778

Impact of Diet and Lifestyle Modification on the Intestinal Barrier Integrity in Crohn's Disease

Led by Universität Duisburg-Essen · Updated on 2024-12-16

30

Participants Needed

1

Research Sites

139 weeks

Total Duration

On this page

Sponsors

U

Universität Duisburg-Essen

Lead Sponsor

H

Heidelberg University

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this prospective interventional study is to evaluate whether the targeted avoidance of a particular food that was diagnosed to be disruptive for the intestinal barrier during confocal laser endomicroscopy (CLE) contributes significantly to stabilizing the intestinal barrier and improving abdominal symptoms, quality of life and disease activity in Crohn's Disease patients with food-related symptoms. The main questions the study aims to answer are: * whether a food-induced intestinal barrier disorder in Crohn's disease patients can be detected by endoscopy using confocal laser endomicroscopy (CLE) and a causal relationship with certain foods can be established. * whether a change in diet or a targeted elimination diet can restore the defective integrity of the intestinal barrier detected by CLE. * to examine whether a targeted avoidance of a food that was identified by CLE to trigger intestinal barrier disruption leads to a relevant improvement in symptoms, quality of life and disease activity in patients with Crohn's disease. Participants will undergo a two-stage nutritional therapy concept based on a two-week inpatient integrative medicinal lifestyle modification program that comprises nutritional therapy, stress management strategies, mind-body medicine, herbal medicine and exercise: * Initially, participants learn how to employ the comprehensive lifestyle modification concept and receive nutritional training on a mostly vegetarian Mediterranean wholefood diet. * In a first stabilization phase, lasting for 3 months, participants independently apply the taught Mediterranean diet and use strategies from the comprehensive lifestyle modification program. * In a second elimination phase, lasting for another 3 months, participants additionally avoid the particular food that was identified by CLE to induce an intestinal barrier defect. Crohn's disease patients will: * initially receive a clinically indicated endoscopy with CLE and food challenge to examine whether a food-induced intestinal barrier disorder is present * return to the clinic for an optional endoscopy with CLE and food challenge after the first (stabilization) phase as well as the second (elimination) phase * answer questionnaires at study start as well as after the first and the second study phase to analyze their quality of life, the severity of their symptoms and their disease activity * give samples of blood, urine, stool and bile fluid as well as intestinal biopsies during regular inpatient sampling at study start as well as after the first and the second study phase * document their intake of food and their symptoms in an App-based diary throughout the study participation

CONDITIONS

Official Title

Impact of Diet and Lifestyle Modification on the Intestinal Barrier Integrity in Crohn's Disease

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age more than 18 years
  • Diagnosed with Crohn's Disease for at least 6 months
  • Have suspected food-induced symptoms or irritable bowel syndrome-like symptoms lasting at least 3 months with moderate to severe severity
  • Using stable doses of IBD-specific medications such as 5-ASA, thiopurines, or biologicals for at least 3 months
  • Admitted as an inpatient to the clinic for internal and integrative medicine in Bamberg for regular treatment
  • Have clinical indication and undergo initial esophagogastroduodenoscopy with confocal laser endomicroscopy showing a food-induced intestinal barrier disorder
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Having a severe flare of Crohn's disease
  • Having an artificial intestinal outlet
  • Having IgE-mediated type 1 allergy to foods tested by CLE (egg white, soy, milk, yeast, wheat)
  • Having macroscopic inflammation of the duodenum detected by endoscopy
  • Being pregnant or breastfeeding
  • Having chronic alcohol or drug abuse
  • Treated with antibiotics within one month before study start
  • Having acute or chronic infectious, inflammatory, or autoimmune intestinal diseases or other organ diseases such as chronic hepatitis or rheumatoid arthritis
  • Having malignant diseases affecting internal organs within the last 5 years
  • Having severe mental disorders impairing study understanding or adherence
  • Unable to give written consent or follow study protocols
  • Participated in another therapeutic study within the last 30 days (except health services research)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Sozialstiftung Bamberg

Bamberg, Bavaria, Germany, 96049

Actively Recruiting

Loading map...

Research Team

A

Angelika Schmalzl, Dr. rer. nat.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here