Status:
NOT_YET_RECRUITING
Comparison of Quality of Life During a Flare of Crohn's Disease Treated With Prednisolone or aCDED With PEN in Adult Patients
Lead Sponsor:
University Hospital Tuebingen
Collaborating Sponsors:
Société des Produits Nestlé (SPN)
Conditions:
Crohn Disease
Nutrition Assessment
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 progres...
Detailed Description
Crohn's disease (CD), a subgroup of inflammatory bowel disease (IBD), is increasing in incidence worldwide. Despite great advances in medical treatment, CD is associated with considerable morbidity re...
Eligibility Criteria
Inclusion
- Must be ≥ 18 years at the time of signing the informed consent.
- Patients with a diagnosis of CD-duration of disease up to 36 months
- 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 ≥ 200
- 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
- Patients with with minimal disease activity (CDAI \<200) 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.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT06953791
Start Date
May 1 2025
End Date
May 1 2027
Last Update
May 1 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.