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RECRUITING
NCT05791487
NA

Combination of Diet and Oral Budesonide for Ulcerative Colitis

Sponsor: Wolfson Medical Center

View on ClinicalTrials.gov

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

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