Prednisolone versus an adapted Crohn's disease exclusion diet plus partial enteral nutrition for adult Crohn's flares

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional study compares standard oral prednisolone with an adapted Crohn's disease exclusion diet (aCDED) plus partial enteral nutrition (Modulen) in adults having a Crohn's flare. Eligible participants have macroscopic small-bowel involvement or disease confined to the right or transverse colon and a Crohn's Disease Activity Index (CDAI) ≥150. Participants receive one of the two treatment approaches with dietary counseling and a standardized enteral formula where applicable, and are followed for quality of life, clinical response, and nutritional outcomes. The study is conducted at a single academic center with close follow-up to monitor adherence and safety.

Why it matters

Who can join: the full rules

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's running

• Universitätsklinik Tübingen
  Tübingen, Germany Recruiting

Study contacts

• Principal investigator: Karsten Büringer, MD — Head of Department of Inflammatory Bowel Disease/Endoscopy
• Study coordinator: Lisa Sinnigen, MD
• Email: consistent@med.uni-tuebingen.de
• Phone: +4970712961989

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.