Contacts

Joshua Korzenik, MD

CONTACT

617 732-6389 jkorzenik@bwh.harvard.edu

Siani Ellis

CONTACT

617-396-7703 sellis13@bwh.harvard.edu

Sponsors

Lead Sponsor

Brigham and Women's Hospital

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Ability to give consent
•Patients with a confirmed diagnosis of UC for \> 3 months
•History of ≥ 15 cm of colonic involvement as confirmed by colonoscopy
•Disease activity based on calprotectin \> 200
•Allowed medications: mesalamine and sulfasalazine
•Patients with primary sclerosing cholangitis are eligible to enroll

Exclusion Criteria

•History of uncontrolled hypertension with systolic BP \> 140 and systolic BP \> 90
•Chronic kidney disease as defined by GFR \<55mL/min
•Impaired hepatic function (transaminases elevated \> 2.5 x ULN) unless due to PSC
•Evidence of C. difficile (Negative test result within 1 month is acceptable)
•Infectious Colitis or drug induced colitis
•Crohn's Disease or Indeterminate colitis
•Decompensated liver disease
•Patients who are pregnant or breastfeeding
•Use of rectal therapies
•Patients who have a confirmed malignancy or cancer within 5 years
•Congenital or acquired immunodeficiencies
•Other comorbidities including: Diabetes mellitus, systemic lupus
•High likelihood of colectomy in the next 2 months
•Participation in a therapeutic clinical trial in the preceding 30 days or simultaneously during this trial
•Patients with a history or risk of cardiovascular conditions, including arrhythmia, long QT syndrome, congestive heart failure, stroke, or coronary artery disease
•Prohibited medications: Vitamin C, prednisone, immune modulators (including but not limited to azathioprine, 6-mercaptopurine, mycophenolate mofetil, tacrolimus, cyclosporine, thalidomide, interleukin-10, interleukin-11, and Omvoh or mirikizumab-mrkz) and biologics within the past six weeks including anti-TNF agents within the past six weeks, vedolizumab within the past six weeks, ustekinumab Risankizumab), a JAKi (tofacitinib or upadacitinib), or Velsipity (etrasimod) within the past 6 weeks. (The aim is to treat people who are having disease activity and just on mesalamine.)