Hydroxocobalamin Approach for Reducing of Calprotectin With Butyrate for Ulcerative Colitis Remission

Withdrawn before enrolling · Phase 2 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

This is a 4-week pilot, multicenter, randomized, double-blinded placebo controlled trial of hydroxocobalamin and butyrate in ulcerative colitis (UC) that will occur in two phases. The main objectives of this study are to determine the capacity of hydroxocobalamin and butyrate to reduce calprotectin in those with inflammatory disease in UC to determine the safety and preferential dose of hydroxocobalamin with butyrate in UC.

Key facts

Study ID

NCT04259060

Run by

Joshua Korzenik

People needed

0

Starts

2024-01-01

Expected to finish

2025-10-01

Last updated by the study team

2024-04-22

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-75
• 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
• Partial Mayo score of > 4 for phase one or a total Mayo score > 5 in phase 2
• Patients with primary sclerosing cholangitis are eligible to enroll

You may not qualify if…

• History of uncontrolled hypertension with a systolic BP > 140 and a systolic BP > 90
• Chronic kidney disease as defined by a GFR <60mL/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 to confirm
• Infectious Colitis or drug induced colitis
• Crohn's Disease or Indeterminate colitis
• Decompensated liver disease
• Patients who are pregnant or breastfeeding
• Prohibited medications: Vitamin C, prednisone, immune modulators (including but not limited to azathioprine, 6-mercaptopurine, mycophenolate mofetil, tacrolimus, cyclosporine, thalidomide, interleukin-10 and interleukin-11) and anti-TNF agents within the past six weeks
• Use of rectal therapies
• Patients who have a confirmed malignancy or cancer within 5 years
• Participation in a therapeutic clinical trial in the preceding 30 days or simultaneously during this trial
• Congenital or acquired immunodeficiencies
• Other comorbidities including: Diabetes mellitus, systemic lupus
• Patients with a history of kidney stones
• Patients with a history or risk of cardiovascular conditions, including arrhythmia, long QT syndrome, congestive heart failure, stroke, or coronary artery disease
• High likelihood of colectomy in the next 2 months

Where it is running

• Brigham and Women's Hospital — Chestnut Hill, Massachusetts, United States

Full record on ClinicalTrials.gov

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