RecruitingPhase 2NCT06953791

Comparison of Quality of Life During a Flare of Crohn's Disease Treated With Prednisolone or aCDED With PEN in Adult Patients

Comparison of Quality of Life During a Flare of Crohn's Disease Treated With Standard of Care or an Adapted Crohn's Disease Exclusion Diet With Partial Enteral Nutrition in Adult Patients


Sponsor

University Hospital Tuebingen

Enrollment

52 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Crohn's disease (CD), a type of inflammatory bowel disease (IBD), is on the rise globally. Although medical treatments have advanced, CD still leads to significant health issues due to disease progression and medication side effects. Exclusive enteral nutrition (EEN) is a recommended first-line treatment for pediatric CD, proving more effective than oral corticosteroids without side effects. However, EEN demands strict adherence, making it challenging for patients, particularly adults. In 2019, Levine et al. found that a combination of a specific diet (CD exclusion diet, CDED) and partial enteral nutrition (PEN) was as effective as EEN in inducing remission in pediatric patients, with better tolerance and adherence. CDED focuses on whole foods and aims to minimize harmful dietary components affecting the gut. In clinical practice, an adapted CDED (aCDED) has been used to provide more food choices, but it lacks validation in clinical trials. An aCDED that considers regional and seasonal food variations could enhance patient adherence and align with modern dietary preferences. This study aims to compare the quality of life during a flare up of Crohn's disease treated with standard of care or an adapted Crohn's disease exclusion diet with partial enteral nutrition in adult patients.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares the quality of life of people with Crohn's disease who experience a flare-up while being treated with either prednisolone (a common oral steroid) or budesonide (another steroid that works more locally in the gut). Researchers want to know which treatment is easier on patients day-to-day during an active flare. **You may be eligible if...** - You are 18 or older with a confirmed diagnosis of Crohn's disease - You are currently experiencing a flare-up (moderate disease activity based on a standard score of 150 or higher) - Your disease affects the small bowel, or the right or middle part of the large bowel - You are stable on any existing background medications like 5-ASA or immunomodulators **You may NOT be eligible if...** - Your disease is very mild (score below 150) or very severe (score above 450) - You have taken any steroid medication in the past 4 weeks - You are currently on a biologic drug or small molecule therapy (such as vedolizumab or upadacitinib) - Your Crohn's disease only affects the lower left portion of the colon - You have complications like an abscess or fistula (tunneling infection) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTaCDED + Modulen

Unique diet + partial enteral nutrition (PEN): This group will receive as follows: * Weeks 1-6: 50% of dietary needs from PEN (Modulen, ModuLife phase I) and 50% from a limited whole food diet * Weeks 7-12: 25% of dietary needs from PEN (Modulen, ModuLife phase II) and 75% from a limited whole food diet * Weeks 12-48: liberal diet and Modulen as needed

DRUGPrednisolone

1 mg/kg, tapering scheme


Locations(1)

Universitätsklinik Tübingen

Tübingen, Germany

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NCT06953791


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