Actively Recruiting
Comparison of Quality of Life During a Flare of Crohn's Disease Treated With Prednisolone or aCDED With PEN in Adult Patients
Led by University Hospital Tuebingen · Updated on 2026-02-05
52
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
U
University Hospital Tuebingen
Lead Sponsor
S
Société des Produits Nestlé (SPN)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Comparison of Quality of Life During a Flare of Crohn's Disease Treated With Prednisolone or aCDED With PEN in Adult Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must be 18 years or older at the time of signing informed consent
- Confirmed macroscopic small bowel involvement or isolated large bowel disease confined to right or transverse colon by endoscopy
- Crohn's disease activity index (CDAI) of 150 or higher
- Stable use of 5ASA or immunomodulator for more than 8 weeks, or starting thiopurine concurrently
- Understand and voluntarily sign informed consent
- Able to follow study visit schedule and protocol requirements
- Agree to refrain from donating blood while on study drugs
- Agree not to share medication
- Willing to use highly effective contraception during treatment and for 28 days after treatment
You will not qualify if you...
- Patients with minimal disease activity (CDAI less than 150) or severe disease (CDAI greater than 450)
- Use of corticosteroids within the previous 4 weeks
- Started immunomodulator treatment within the previous 8 weeks
- Current biological or small molecule treatment
- Isolated large bowel disease involving recto-sigmoid or descending colon
- Presence of penetrating disease such as abscess or fistula
- Active perianal disease
- Fixed stricture or small bowel obstruction
- Normal fecal calprotectin levels
- Active extraintestinal disease like joint disease
- Previous intestinal resection
- Diagnosis of sclerosing cholangitis
- History of hypersensitivity to study medication or similar drugs
- Women who are pregnant or breastfeeding
- Participation in other clinical trials or observation periods of competing trials
AI-Screening
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Trial Site Locations
Total: 1 location
1
Universitätsklinik Tübingen
Tübingen, Germany, 72076
Actively Recruiting
Research Team
L
Lisa Sinnigen, MD
CONTACT
R
Ronald Keller, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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