Diet and Budesonide for Ulcerative Colitis Treatment
Remission With Diet for Ulcerative Colitis Exacerbations: A Single Blinded, International Randomized Controlled Clinical and Translational Trial
This study is testing if a special diet combined with a medication can help adults and teens with mild to moderate ulcerative colitis feel better and heal their intestines.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 17 Years to 65 Years |
| Sex | All |
| Sponsor | Wolfson Medical Center Government |
| Drugs / interventions | Ustekinumab, tofacitinib |
| Locations | 6 sites (Afula and 5 other locations) |
| Trial ID | NCT05791487 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of the Ulcerative Colitis Exclusion Diet (UCED) combined with oral budesonide in adults and adolescents with mild to moderate ulcerative colitis. Participants will be randomly assigned to receive either the dietary intervention alongside budesonide or budesonide alone for a period of 6 weeks, followed by a maintenance phase. The study aims to assess improvements in remission rates and mucosal healing through changes in the microbiome. It is a 24-week multinational single-blinded randomized controlled trial.
Who should consider this trial
Good fit: Ideal candidates are adults and adolescents aged 17-65 with mild to moderate active ulcerative colitis.
Not a fit: Patients with severe colitis or those who have recently used steroids or anti-TNF therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-immunosuppressive treatment option for patients with ulcerative colitis.
How similar studies have performed: While dietary interventions in ulcerative colitis are being explored, this specific combination of diet and budesonide is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Informed consent * Established diagnosis of UC with mild to moderate active disease, 5 ≤ SCCAI ≤ 10 * Age: 17-65 years (inclusive) * Extent E1-E3 by the Montreal classification * Active colitis in the rectum or sigmoid colon on sigmoidoscopy * Stable medication use of oral 5ASA for at least 8 weeks, thiopurines, vedolizumabs, Ustekinumab or tofacitinib for at least 12 weeks Exclusion Criteria: * Severe colitis (SCCAI\>10) hospitalization for acute severe colitis (ASC) in the previous 6 months * Use of steroids in the previous 3 months * Patients treated with Anti-TNF currently or in patients who had previously failed or lost response to anti TNF * Vegans (vegetarians may enroll) * Pregnancy * Inability use of budesonide due to severe adverse events * Extraintestinal manifestations such as arthritis, spondyloarthropathy or uveitis * Presence of baseline hypoalbuminemia * Fever \>38°C * Evidence for Clostridioides difficile infection * Renal failure * Hepatitis or PSC (Primary Sclerosing Cholangitis) * Active malignancy (excluding skin BCC).
Where this trial is running
Afula and 5 other locations
- Emek Medical Center — Afula, Israel (Not_yet_recruiting)
- Wolfson Medical Center — Holon, Israel (Recruiting)
- Tel Aviv Sourasky Medical Center — Tel Aviv, Israel (Recruiting)
- FONDAZIONE GEMELLI HOSPITAL Catholic University of the Sacred Hearth — Roma, Italy (Not_yet_recruiting)
- Radboud University Medical Center (Radboudumc) — Nijmegen, Netherlands (Not_yet_recruiting)
- Kantonsspital St. Gallen — Sankt Gallen, Switzerland (Recruiting)
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.