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

NCT06719778 | Recruiting

• 1 other identifier: 23067
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Crohn's Disease

Keywords

integrative medicine; lifestyle modification; intestinal barrier; Mediterranean diet; inflammatory bowel disease; Confocal Laser Endomicroscopy; Crohn Disease; microbiome; nutrition; irritable bowel

Outcome Measures

Primary Outcomes (1)

• Improvement of the integrity of the duodenal intestinal barrier analyzed by confocal laser endomicroscopy (CLE)

  The integrity of the intestinal barrier is tested by CLE during routine Oesophagogastroduodenoscopy. By CLE, the intestinal mucosa and the epithelial lining can be analyzed in vivo with a 1000 x magnification. An intestinal barrier defect can be detected by the leakage of a contrast agent (fluorescein) from the blood vessels through the intestinal epithelial spaces into the intestinal cavity and the shedding of epithelial cells. The impact of 5 foodstuffs (egg white, soy, milk, yeast, wheat) on the intestinal barrier is tested subsequently. The integrity of the intestinal barrier and the reaction to the 5 foodstuffs is tested at baseline as well as after phase 1 (at week 12) and after phase 2 (week 24) in order to identify whether a dietary change or the omission of a particular foodstuff that was identified by baseline CLE to be intestinal barrier disrupting, lead to a relevant improvement in barrier integrity.

  week 0, 12, 24

Secondary Outcomes (44)

• Severity of IBS symptoms by IBS-SSS (Irritable Bowel Severity scoring system)

  week 0, 12, 24

• Severity of IBD-SI (Inflammatory Bowel Disease Symptom Inventory)

  week 0, 12, 24

• Severity of HBI (Harvey-Bradshaw-Index)

  week 0, 12, 24

• Disease-specific quality of life by IBD-Q (Inflammatory Bowel Disease Questionnaire)

  week 0, 12, 24

• Diagnosis of functional bowel disorders using Rome IV criteria

  week 0, 12, 24

Study Arms (1)

Application of a two-stage nutritional therapy concept

EXPERIMENTAL

Sequencing of the inpatient integrative medicinal lifestyle modification program applied at the clinic for internal and integrative medicine in Bamberg into a two-stage nutritional therapy concept

Other: Two-stage nutritional therapy concept

Interventions

Two-stage nutritional therapy concept OTHER

1. Stabilization phase: application of a mostly vegetarian Mediterranean wholefood diet and strategies from a comprehensive lifestyle modification concept. 2. Elimination phase: additional omission diet avoiding the food that was identified by CLE to induce an intestinal barrier defect.

Application of a two-stage nutritional therapy concept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age more than 18 years
• Crohn's Disease for at least 6 months (date of initial diagnosis)
• with suspected food-induced symptoms or irritable bowel syndrome-like symptoms (fulfils IBS-Rom-IV criteria) for at least 3 months with moderate to severe symptom severity
• stable IBD-specific medication dosage for at least 3 months \[such as 5-aminosalicylates (5-ASA), thiopurines or biologicals (therapeutic antibodies such as infliximab, adalimumab, vedolizumab, etc.)\].
• inpatient admission to the clinic for internal and integrative medicine in Bamberg for regular treatment
• clinical indication and performance of an initial esophagogastroduodenoscopy with confocal laser endomicroscopy with detection of a food-induced intestinal barrier disorder
• signed informed consent form

You may not qualify if:

• severe flare of Crohn's disease
• artificial intestinal outlet
• IgE-mediated type 1 allergy to CLE-tested foods (egg white, soy, milk, yeast, wheat)
• macroscopic inflammation of the duodenum (detected via endoscopy)
• pregnancy or breastfeeding
• chronic alcohol or drug abuse
• treatment with antibiotics within one month before the start of the study
• Acute or chronic infectious, inflammatory or autoimmune intestinal diseases (such as coeliac disease, Whipples disease, lambliasis, eosinophilia, ulcerative colitis, infectious enterocolitis) or other organs (such as chronic hepatitis, autoimmune hepatitis, rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis)
• malignant diseases affecting internal organs within the last 5 years (such as colorectal cancer, stomach cancer, pancreatic cancer, liver cancer, lung cancer, breast cancer)
• severe mental disorders that impair the participant's ability to understand or follow the study protocol (e.g. uncontrolled schizophrenia, severe bipolar disorder, severe depression)
• inability to give written consent or follow study protocols
• participation in another therapeutic study within the last 30 days (except health services research)

Sponsors & Collaborators

• Universität Duisburg-Essen: lead
• Heidelberg University: collaborator
• German Crohn's and Colitis Association (DCCV e.V.): collaborator

Study Sites (1)

Sozialstiftung Bamberg

Bamberg, Bavaria, 96049, Germany

RECRUITING

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases; Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colonic Diseases, Functional; Colonic Diseases

Study Officials

• Jost Langhorst, Univ. Prof. Dr. med.

  Universität Duisburg-Essen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angelika Schmalzl, Dr. rer. nat.

CONTACT

0049 951 503 11650; FIGN@sozialstiftung-bamberg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Univ. Prof. Dr. med

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 6, 2024
• Study Start: August 1, 2024
• Primary Completion: April 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)