The ReDUCE Trial is a multinational single-blinded randomized controlled trial in mild to moderate flare of Ulcerative colitis (UC) disease patients. The purpose of the study is to validate the clinical efficacy of the UCED (Ulcerative colitis Exclusion Diet) with partial enteral nutrition (PEN) using a novel formula.
The investigators anticipate that adding a novel specifically designed dietary intervention in addition to drug will lead to superior remission and mucosal healing via changes in the microbiome.
Who can participate
Age range
17 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.