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RECRUITINGINTERVENTIONAL

Combination of Diet and Oral Budesonide for Ulcerative Colitis

Remission With Diet for Ulcerative Colitis Exacerbations: A Single Blinded, International Randomized Controlled Clinical and Translational Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 May Be Eligible (Plain English)

Who May Qualify: - willing to sign a consent form - 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 Who Should NOT Join This Trial: - 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). Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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).

Treatments Being Tested

OTHER

Ulcerative colitis Exclusion Diet

a limited whole food diet (UCED)

OTHER

Partial enteral nutrition (PEN)

The diet will be supplemented by 3 glasses a day (750 m"l) of the formula developed for UC using the UCED principles.

OTHER

free diet

oral Budeosnide for 6 weeks + free diet

DRUG

Oral Budesonide

Oral Budesonide 9 mg

Locations (6)

Emek Medical Center
Afula, Israel
Wolfson Medical Center
Holon, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
FONDAZIONE GEMELLI HOSPITAL Catholic University of the Sacred Hearth
Roma, Italy
Radboud University Medical Center (Radboudumc)
Nijmegen, Netherlands
Kantonsspital St. Gallen
Sankt Gallen, Switzerland