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Hydroxocobalamin Approach for Reducing of Calprotectin With Butyrate for Ulcerative
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.
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.
Age
18 - 75 years
Sex
ALL
Healthy Volunteers
No
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, United States
Start Date
January 1, 2024
Primary Completion Date
August 1, 2025
Completion Date
October 1, 2025
Last Updated
April 22, 2024
Hydroxocobalamin with Butyrate
DRUG
Placebo with Butyrate
DRUG
Lead Sponsor
Joshua Korzenik
NCT07271069
NCT06975722
Data Source & Attribution
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Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT07185009