Prednisolone versus an adapted Crohn's disease exclusion diet plus partial enteral nutrition for adult Crohn's flares
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
PHASE2 · University Hospital Tuebingen · NCT06953791
This trial tests whether an adapted Crohn's exclusion diet combined with partial enteral nutrition works as well as prednisolone for adults experiencing a Crohn's disease flare.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Tuebingen (other) |
| Locations | 1 site (Tübingen) |
| Trial ID | NCT06953791 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with an active Crohn's disease flare, documented small-bowel or right/transverse colonic involvement, and CDAI ≥150 who can adhere to a diet program and attend study visits are ideal candidates.
Not a fit: Patients with severe or complicated disease needing urgent immunosuppression or surgery, those unable to follow a restrictive diet or receive enteral nutrition, or those with disease outside the included segments may not benefit.
Why it matters
Potential benefit: If successful, it could provide an effective steroid-sparing treatment that improves quality of life and reduces medication-related side effects.
How similar studies have performed: Pediatric trials have shown that a Crohn's exclusion diet plus partial enteral nutrition can match exclusive enteral nutrition for inducing remission, but adult evidence is limited and the adapted diet used here lacks formal adult validation.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Tübingen
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Crohn Disease, Nutrition Assessment, Diet Therapy, Nutrition, crohn disease, diet therapy, consistent