Combination of Diet and Oral Budesonide for Ulcerative Colitis
NCT ID: NCT05791487
Last Updated: 2024-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
90 participants
INTERVENTIONAL
2023-12-01
2026-09-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Budesonide for Induction of Remission in Incomplete Microscopic Colitis
NCT02142634
Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis
NCT04314375
Dose Ranging Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Rectal Foam in Pediatric Patients Aged 5 to 17 Years With Active, Mild to Moderate Distal Ulcerative Colitis
NCT05976802
Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis
NCT01008410
The Safety and Tolerability of Budesonide Foam in Participants With Active Ulcerative Proctitis or Proctosigmoiditis
NCT01349673
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Thus, developing a dietary therapy that would treat the cause of the disease, while having no side effects, would likely lead to immediate implementation and be sought out by patients hesitant to be on lifelong medications or immune suppression.
Objectives: To evaluate if the UC Exclusion Diet (UCED), can improve outcomes when administered with an oral budesonide regimen to adult patients with mild to moderate UC.
Methods: This will be a 24-week multinational single-blinded randomized controlled trial.
After a baseline flexible sigmoidoscopy, Group 1 will receive oral budesonide 9 mg topical therapy + the UCED+PEN phase 1 diet for 6 weeks, while Group 2 will receive oral budesonide 9 mg topical therapy alone for 6 weeks with no dietary intervention.
Both groups will continue the previous maintenance therapy through week 12 and both groups will stop budesonide at week 6.
Group 1 will continue with the phase 2 diet/PEN from week 7-12 while group 2 will stay on habitual diet. A flexible sigmoidoscopy will be repeated at week 12.
Population: adults and adolescents between the ages of 17-65 with a mild to moderate active disease (Simple Clinical Colitis Activity Index (SCCAI) 5-10 with an endoscopic Mayo score 1-3), on an existing maintenance therapy comparing two arms.
Time frame: The induction of remission phase will last 8 weeks followed by maintenance phase for a period of 24 weeks
Expected outcomes and significance: 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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ulcerative colitis Exclusion Diet + Partial enteral nutrition
Participants 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.
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.
Oral Budesonide
Oral Budesonide 9 mg
Free diet
Participants in Group 2 will receive oral budesonide 9 mg topical therapy alone for 6 weeks with no dietary intervention
free diet
oral Budeosnide for 6 weeks + free diet
Oral Budesonide
Oral Budesonide 9 mg
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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).
17 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Wolfson Medical Center
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Sarbagili-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.
Related Links
Access external resources that provide additional context or updates about the study.
Related Info
Related Info
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
0073-22-WOMC
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.