Comparison of Quality of Life During a Flare of Crohn's Disease Treated With Prednisolone or aCDED With PEN in Adult Patients
Recruiting · NCT06953791 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital Tuebingen
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
Inclusion criteria
- Must be ≥ 18 years at the time of signing the informed consent.
- Macroscopic small bowel involvement, or isolated large bowel disease confined to the right or transverse colon confirmed by endoscopy
- Patients with a Crohn's disease activity index (CDAI) of ≥ 150
- Patients will not be excluded if they have received 5ASA or an immunomodulator for \> 8 weeks and the dose is stable, or if they start a thiopurine concurrently, as thiopurines are not considered sufficient to induce remission in active disease before 8 weeks as an isolated therapy
- Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures
- Able to adhere to the study visit schedule and other protocol requirements
- All subjects must agree to refrain from donating blood while on study drugs
- All subjects must agree not to share medication.
- Subject (male or female) is willing to use highly effective contraceptive methods during treatment and for 28 days (male or female) after the end of treatment
Exclusion criteria
- Patients with with minimal disease activity (CDAI \<150) or severe disease (CDAI \>450)
- Patients who have received corticosteroids of any kind in the previous 4 weeks
- Patients who have started an immunomodulator in the previous 8 weeks
- Any current biological or small molecule treatment
- Isolated large bowel disease iinvolving the recto-sigmoid or descending colon
- Patients with penetrating disease (abscess or fistula)
- Active perianal disease
- Fixed stricture or small bowel obstruction
- Normal fecal calprotectin
- Active extraintestinal disease (e.g. joint disease)
- Patients who have undergone an intestinal resection
- Sclerosing cholangitis
- History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
- Women during pregnancy and lactation Participation in other clinical trials or observation period of competing trials.
Where it is running
1 location listed.
- Universitätsklinik Tübingen - Tübingen, Germany