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

Ulcerative Colitis Clinical Trial

Official title:
Hydroxocobalamin Approach for Reducing of Calprotectin With Butyrate for Ulcerative

Clinical Trial 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.

Clinical Trial Description

The goal of this study is to determine the preferable dose of hydroxocobalamin in a 4-week pilot study in patients with UC and determine if this approach can reduce stool calprotectin. Before going forward with a larger efficacy trial, the investigators are first aiming to determine if the supplements/medications we are proposing to use are sufficient to reduce a biomarker. Consequently, this study will look at a more easily measurable biomarker to provide evidence that the dosing is sufficient. This pilot study will be conducted to assess preferable dose of hydroxocobalamin based on reduction of calprotectin. The investigators aim to determine if this reduction is sustained over time and is correlated to changes in clinical disease activity. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04259060
Study type Interventional
Source Brigham and Women's Hospital
Contact
Status Withdrawn
Phase Phase 2
Start date January 2024
Completion date October 2025
View Details
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