Actively Recruiting
Combination of Diet and Oral Budesonide for Ulcerative Colitis
Led by Wolfson Medical Center · Updated on 2024-05-23
90
Participants Needed
6
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Combination of Diet and Oral Budesonide for Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Diagnosed Ulcerative Colitis with mild to moderate active disease (SCCAI 5 to 10)
- Age between 17 and 65 years inclusive
- Disease extent E1 to E3 by Montreal classification
- Active colitis in rectum or sigmoid colon confirmed by sigmoidoscopy
- Stable use of oral 5ASA for at least 8 weeks, or thiopurines, vedolizumab, ustekinumab, or tofacitinib for at least 12 weeks
You will not qualify if you...
- Severe colitis (SCCAI greater than 10) or hospitalization for acute severe colitis within past 6 months
- Steroid use within previous 3 months
- Current anti-TNF treatment or previous failure/loss of response to anti-TNF
- Vegan diet
- Pregnancy
- Unable to use budesonide due to severe adverse events
- Extraintestinal manifestations like arthritis, spondyloarthropathy, or uveitis
- Baseline hypoalbuminemia
- Fever over 38 degrees Celsius
- Evidence of Clostridioides difficile infection
- Renal failure
- Hepatitis or Primary Sclerosing Cholangitis (PSC)
- Active malignancy excluding skin basal cell carcinoma
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
Emek Medical Center
Afula, Israel, 1834111
Not Yet Recruiting
2
Wolfson Medical Center
Holon, Israel, 58100
Actively Recruiting
3
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 6423906
Actively Recruiting
4
FONDAZIONE GEMELLI HOSPITAL Catholic University of the Sacred Hearth
Roma, Italy, 00168
Not Yet Recruiting
5
Radboud University Medical Center (Radboudumc)
Nijmegen, Netherlands
Not Yet Recruiting
6
Kantonsspital St. Gallen
Sankt Gallen, Switzerland
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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