drugset / Trial / NCT04259060
Hydroxocobalamin Approach for Reducing of Calprotectin With Butyrate for Ulcerative Colitis Remission
RandomizedSequentialDouble-blindTreatment
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.
Timeline
- Start
- 2024-01
- Primary completion
- 2025-08
- Completion
- 2025-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Hydroxocobalamin | Unknown | 500 mg | Oral |
| Comparator | Hydroxocobalamin | Unknown | 1000 mg | Oral |
| Comparator | BUTYRIC ACID | Small molecule | 120 mg | Oral |