Diet and lifestyle changes to improve gut health in Crohn's Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study aims to evaluate the impact of dietary modifications on the intestinal barrier integrity in patients with Crohn's Disease. By utilizing confocal laser endomicroscopy (CLE), the study seeks to identify food-induced intestinal barrier disorders and assess whether a targeted elimination diet can restore barrier function and alleviate symptoms. Participants will undergo a two-stage nutritional therapy concept while being monitored for changes in their symptoms, quality of life, and disease activity. The study is designed to provide insights into the relationship between diet and gut health in individuals suffering from this chronic condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Where it's running

• Sozialstiftung Bamberg
  Bamberg, Bavaria, Germany Recruiting

Study contacts

• Principal investigator: Jost Langhorst, Univ. Prof. Dr. med. — Universität Duisburg-Essen
• Study coordinator: Angelika Schmalzl, Dr. rer. nat.
• Email: FIGN@sozialstiftung-bamberg.de
• Phone: 0049 951 503 11650

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Tabellvi for moderate to severe Crohn's disease in Chinese adults

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.