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

0073-22-WOMC

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.

2023-12-01

2026-03-01

2026-09-01

Recruiting

90

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).

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'The physician', 'whoMasked': ['CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}

2024-05-23