Phase
Condition
Colic
Ulcerative Colitis
Crohn's Disease
Treatment
free diet
Ulcerative colitis Exclusion Diet
Partial enteral nutrition (PEN)
Clinical Study ID
Ages 17-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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
Exclusion
Exclusion Criteria:
Severe colitis (SCCAI>10) hospitalization for acute severe colitis (ASC) in theprevious 6 months
Use of steroids in the previous 3 months
Patients treated with Anti-TNF currently or in patients who had previously failed orlost 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).
Study Design
Study Description
Connect with a study center
Emek Medical Center
Afula, 1834111
IsraelSite Not Available
Wolfson Medical Center
H̱olon, 58100
IsraelActive - Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906
IsraelActive - Recruiting
FONDAZIONE GEMELLI HOSPITAL Catholic University of the Sacred Hearth
Roma, 00168
ItalySite Not Available
Radboud University Medical Center (Radboudumc)
Nijmegen,
NetherlandsSite Not Available
Kantonsspital St. Gallen
Saint Gallen,
SwitzerlandActive - Recruiting
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