Combination of Diet and Oral Budesonide for Ulcerative Colitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age17-65
SponsorWolfson Medical Center
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Ulcerative colitis Exclusion Diet
- Partial enteral nutrition (PEN)
- free diet
- Oral Budesonide
Treatment groups
90 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov