Diet and lifestyle changes to improve gut health in Crohn's Disease
Prospective Interventional Study to Evaluate the Impact of Diet and Lifestyle Modification on the Intestinal Barrier Integrity in Crohn's Disease
This study is testing if changing what people with Crohn's Disease eat can help improve their gut health and reduce their symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universität Duisburg-Essen Academic / other |
| Drugs / interventions | infliximab, adalimumab, vedolizumab |
| Locations | 1 site (Bamberg, Bavaria) |
| Trial ID | NCT06719778 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a diagnosis of Crohn's Disease for at least 6 months and experiencing food-related symptoms.
Not a fit: Patients with severe flare-ups of Crohn's Disease or those with specific food allergies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for Crohn's Disease, enhancing patients' quality of life and reducing disease activity.
How similar studies have performed: While dietary interventions in Crohn's Disease have been explored, this specific approach using CLE to identify food triggers is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Bamberg, Bavaria
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.