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This study looks at how a two-stage nutritional therapy approach affects the integrity of the intestinal barrier in people with Crohn's Disease. Adults over 18 who have had Crohn's Disease for at least 6 months and have food-related or irritable bowel syndrome-like symptoms can take part. It is a study with no applicable phase and is currently recruiting participants.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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)