Hydroxocobalamin Approach to Reduction of Calprotectin With Butyrate for Ulcerative Colitis Research

• Status: Not yet recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Joshua Korzenik
• Treatments: Hydroxocobalamin; Vitamin B 12

Criteria

Inclusion Criteria:

1. Age 18-75

2. Ability to give consent

3. Patients with a confirmed diagnosis of UC for > 3 months

4. History of > 15 cm of colonic involvement as confirmed by colonoscopy

5. Disease activity based on calprotectin > 200

6. Allowed medications: mesalamine and sulfasalazine

7. Partial Mayo score of > 4 for phase one or a total Mayo score > 5 in phase 2

8. Patients with primary sclerosing cholangitis are eligible to enroll

Exclusion Criteria:

1. History of uncontrolled hypertension with a systolic BP > 140 and a systolic BP > 90

2. Chronic kidney disease as defined by a GFR <60mL/min

3. Impaired hepatic function (transaminases elevated > 2.5 x ULN) unless due to PSC

4. Evidence of C. difficile - negative test result within 1 month is acceptable to confirm

5. Infectious Colitis or drug induced colitis

6. Crohn's Disease or Indeterminate colitis

7. Decompensated liver disease

8. Patients who are pregnant or breastfeeding

9. 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

10. Use of rectal therapies

11. Patients who have a confirmed malignancy or cancer within 5 years

12. Participation in a therapeutic clinical trial in the preceding 30 days or simultaneously during this trial

13. Congenital or acquired immunodeficiencies

14. Other comorbidities including: Diabetes mellitus, systemic lupus

15. Patients with a history of kidney stones

16. Patients with a history or risk of cardiovascular conditions, including arrhythmia, long QT syndrome, congestive heart failure, stroke, or coronary artery disease

17. High likelihood of colectomy in the next 2 months