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New treatment option for Crohn's Disease
Official title Impact of Diet and Lifestyle Modification on the Intestinal Barrier Integrity in Crohn's Disease
ClinicalTrials.gov ID: NCT06719778
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- stable IBD-specific medication dosage for at least 3 months [such as 5-aminosalicylates (5-ASA), thiopurines or biologicals (therapeutic antibodies...
- inpatient admission to the clinic for internal and integrative medicine in Bamberg for regular treatment
You likely can't join 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
See the full eligibility 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
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Bamberg, Bavaria, Germany
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bamberg, Bavaria, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.