💬In plain words
What the trial is, and whether it could suit you
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
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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)
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