RecruitingNot ApplicableNCT05791487

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


Sponsor

Wolfson Medical Center

Enrollment

90 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 17 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining a specific diet with a short course of oral budesonide (a mild steroid that works mainly in the gut) can improve symptoms in people with mild to moderate active ulcerative colitis (UC). The study aims to find a safer, less systemic alternative to stronger steroids. **You may be eligible if...** - You are between 17 and 65 years old - You have a confirmed diagnosis of ulcerative colitis with mild to moderate activity - You are currently on stable medication for UC (e.g., mesalazine, thiopurines, or certain biologics) - Your colitis affects the rectum or lower colon **You may NOT be eligible if...** - Your colitis is severe or you were hospitalized for it in the last 6 months - You have used steroids in the past 3 months - You are currently on or have previously failed anti-TNF therapy - You are vegan (vegetarians may still be eligible) - You are pregnant - You have complications like arthritis, eye inflammation, or other extraintestinal manifestations of UC - You have active infections, serious liver disease, or kidney failure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERUlcerative colitis Exclusion Diet

a limited whole food diet (UCED)

OTHERPartial 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.

OTHERfree diet

oral Budeosnide for 6 weeks + free diet

DRUGOral 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

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NCT05791487


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