Combination of Diet and Oral Budesonide for Ulcerative Colitis
ReDUCE
Remission With Diet for Ulcerative Colitis Exacerbations: A Single Blinded, International Randomized Controlled Clinical and Translational Trial
1 other identifier
interventional
90
4 countries
6
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2023
Typical duration for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 16, 2023
CompletedFirst Posted
Study publicly available on registry
March 30, 2023
CompletedStudy Start
First participant enrolled
December 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
ExpectedMay 23, 2024
May 1, 2024
2.2 years
February 16, 2023
May 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Steroid free remission
Steroid free intention-to-treat (ITT) remission according to SCCAI\<3 at week 12 \*The Simple Clinical Colitis Activity Index (SCCAI). score ranges from 0 to 19. clinical remission will be defined according to SCCAI\<3
week 12
Secondary Outcomes (6)
Clinical response
week 12
Steroids free remission
week 6
Sustained steroid free remission
week 24
Endoscopic remission
week 12
Change in medical therapy
by week 12
- +1 more secondary outcomes
Study Arms (2)
Ulcerative colitis Exclusion Diet + Partial enteral nutrition
EXPERIMENTALParticipants in Group 1 will receive the UCED combined with partial enteral nutrition (PEN) using a novel nutritional formula for 6 weeks (diet phase 1) that will add to oral budesonide 9 mg topical therapy for 6 weeks and will follow diet + PEN (phase 2: wk6-wk12) and diet phase 3 for 24 weeks.
Free diet
ACTIVE COMPARATORParticipants in Group 2 will receive oral budesonide 9 mg topical therapy alone for 6 weeks with no dietary intervention
Interventions
a limited whole food diet (UCED)
The diet will be supplemented by 3 glasses a day (750 m"l) of the formula developed for UC using the UCED principles.
Oral Budesonide 9 mg
Eligibility Criteria
You may qualify if:
- 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
- Active colitis in the rectum or sigmoid colon on sigmoidoscopy
- Stable medication use of oral 5ASA for at least 8 weeks, thiopurines, vedolizumabs, Ustekinumab or tofacitinib for at least 12 weeks
You may not qualify if:
- 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)
- Pregnancy
- Inability use of budesonide due to severe adverse events
- Extraintestinal manifestations such as arthritis, spondyloarthropathy or uveitis
- Presence of baseline hypoalbuminemia
- Fever \>38°C
- Evidence for Clostridioides difficile infection
- Renal failure
- Hepatitis or PSC (Primary Sclerosing Cholangitis)
- Active malignancy (excluding skin BCC).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Emek Medical Center
Afula, 1834111, Israel
Wolfson Medical Center
Holon, 58100, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906, Israel
FONDAZIONE GEMELLI HOSPITAL Catholic University of the Sacred Hearth
Roma, 00168, Italy
Radboud University Medical Center (Radboudumc)
Nijmegen, Netherlands
Kantonsspital St. Gallen
Sankt Gallen, Switzerland
Related Publications (2)
Sarbagili Shabat C, Scaldaferri F, Zittan E, Hirsch A, Mentella MC, Musca T, Cohen NA, Ron Y, Fliss Isakov N, Pfeffer J, Yaakov M, Fanali C, Turchini L, Masucci L, Quaranta G, Kolonimos N, Godneva A, Weinberger A, Kopylov U, Levine A, Maharshak N. Use of Faecal Transplantation with a Novel Diet for Mild to Moderate Active Ulcerative Colitis: The CRAFT UC Randomised Controlled Trial. J Crohns Colitis. 2022 Mar 14;16(3):369-378. doi: 10.1093/ecco-jcc/jjab165.
PMID: 34514495BACKGROUNDSarbagili-Shabat C, Albenberg L, Van Limbergen J, Pressman N, Otley A, Yaakov M, Wine E, Weiner D, Levine A. A Novel UC Exclusion Diet and Antibiotics for Treatment of Mild to Moderate Pediatric Ulcerative Colitis: A Prospective Open-Label Pilot Study. Nutrients. 2021 Oct 23;13(11):3736. doi: 10.3390/nu13113736.
PMID: 34835992BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Masking Details
- The physician
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2023
First Posted
March 30, 2023
Study Start
December 1, 2023
Primary Completion
March 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
May 23, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share