Clinical Research Directory
Browse clinical research sites, groups, and studies.
Combination of Diet and Oral Budesonide for Ulcerative Colitis
Sponsor: Wolfson Medical Center
Summary
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.
Official title: Remission With Diet for Ulcerative Colitis Exacerbations: A Single Blinded, International Randomized Controlled Clinical and Translational Trial
Key Details
Gender
All
Age Range
17 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2023-12-01
Completion Date
2026-09-01
Last Updated
2024-05-23
Healthy Volunteers
No
Interventions
Ulcerative colitis Exclusion Diet
a limited whole food diet (UCED)
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.
free diet
oral Budeosnide for 6 weeks + free diet
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