Crohn'sRecruiting
Impact of Diet and Lifestyle Modification on the Intestinal Barrier Integrity in Crohn's Disease
Not applicable · Testing Two-stage nutritional therapy concept · 1 site · Universität Duisburg-Essen
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Two-stage nutritional therapy concept as a possible treatment. Condition(s) listed: Crohn's Disease.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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
Plus 1 more requirement(s). There are also 12 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 30 participants are expected to take part.
- The study has 1 group.
- Start date: 2025-03-04.
- Main results expected around 2028-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in Germany.
Groups in this study
- Application of a two-stage nutritional therapy concept (listed as: experimental group)
Main thing being measured
- Improvement of the integrity of the duodenal intestinal barrier analyzed by confocal laser endomicroscopy (CLE) (week 0, 12, 24)
In the researchers’ words
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…
Words you might see
- Endoscopy: a camera exam inside the digestive tract.
- Anti-TNF: a group of biologic medicines (such as infliximab or adalimumab) used in IBD.
- Biologic: a medicine made from living cells, usually given by injection or infusion.
- Biopsy / histology: a small tissue sample examined under a microscope.
- Autoimmune hepatitis: a liver disease where the immune system attacks the liver.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohn's Disease |
| Lead sponsor | Universität Duisburg-Essen |
| Collaborators | Heidelberg University; German Crohn's and Colitis Association (DCCV e.V.) |
| Enrollment | 30 (estimated) |
| Start date | 2025-03-04 |
| Primary completion (est.) | 2028-01 |
| First posted | 2024-12-06 |
| Last updated | 2026-10-13 |
| Official title | Prospective Interventional Study to Evaluate the Impact of Diet and Lifestyle Modification on the Intestinal Barrier Integrity in Crohn's Disease |
| ClinicalTrials.gov ID | NCT06719778 |
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.
Full eligibility criteria (from the record)
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)
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Sozialstiftung Bamberg | Bamberg, Bavaria | Germany | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.