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New treatment option for Ulcerative Colitis
Official title Combination of Diet and Oral Budesonide for Ulcerative Colitis
ClinicalTrials.gov ID: NCT05791487
What this study is testing
What is Oral Budesonide?
Oral Budesonide is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for ulcerative colitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Time commitment: about 8 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 17 to 65
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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).
The study team makes the final eligibility decision.
Where it's taking place
- Afula, Israel
- Holon, Israel
- Tel Aviv, Israel
- Roma, Italy
- Nijmegen, Netherlands
- Sankt Gallen, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 8 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 17 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Afula, Israel; Holon, Israel; Tel Aviv, Israel; Roma, Italy; Nijmegen, Netherlands; Sankt Gallen, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.