A Phase 2 interventional study of Hydroxocobalamin with Butyrate and Placebo with Butyrate in Ulcerative Colitis, sponsored by Joshua Korzenik. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-04-22.
Sponsored by Joshua Korzenik · Phase 2, Interventional, and Treatment
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.
1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.
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Exclusion Criteria:
Subjects enrolled will take hydroxocobalamin capsules twice daily for 4 weeks. All subjects will take an oral butyrate dose of 120 mg twice daily for 4 weeks.
Drug: Hydroxocobalamin with Butyrate
Subjects enrolled will take placebo capsules twice daily for 4 weeks. All subjects will take an oral butyrate dose of 120 mg twice daily for 4 weeks.
Drug: Placebo with Butyrate
In phase 1, patients will take hydroxocobalamin at 1g daily for four weeks. This will be in the form of 1 500mg capsule twice a day. Butyrate will be 240 mg daily in a divided dose (120 mg twice daily) which is 5 pills twice a day. In phase 2, the dose of hydroxocobalamin will be increased to 2g daily (1g twice a day) for four weeks pending FDA approval. Butyrate will remain at 240 mg daily in a divided dose (120 mg twice daily) which is 5 pills twice a day. Patients will undergo flexible sigmoidoscopy at baseline and at week four in phase 2.
In phase 1, patients will take 1 placebo capsule twice a day. Butyrate will be taken at 240 mg daily in a divided dose (120 mg twice daily) which is 5 pills twice a day. In phase 2, patients will take 2 placebo capsules twice a day, along with butyrate at 240 mg daily in a divided dose (120 mg twice daily) which is 5 pills twice a day.
Change from Baseline fecal calprotectin at week 4
Proportion of patients with reductions in fecal calprotectin
Time frame: At baseline and at week 4
Incidence of Treatment-Emergent Adverse Events (AE) as assessed by Common Terminology Criteria for Adverse Events (CTCAE)
CTCAE are a set of criteria for the standardized classification of adverse effects of drugs used in clinical trials. It uses a range of grades from 1 to 5, where 1 is mild and 5 is life-threatening.The number of AE and grade of each AE will be measured for the duration of the trial.
Time frame: Up to 4 weeks
Clinical Symptoms assessed by Simple Clinical Colitis Activity Index (SCCAI)
The SCCAI is an index to measure disease activity in patients with UC. SCCAI will be used throughout the trial to measure clinical UC symptoms of participants.
Time frame: Up to 4 weeks
Assessment of urinary and plasma nitrite, nitrate levels and nitrosothiol levels
Comparison of levels at baseline to week 1-2 and week 4
Time frame: At week 1-2 and at week 4
Normalization of fecal calprotectin below the upper limit of normal
Assessment in number of patients whose fecal calprotectin normalizes
Time frame: At the end of week 4
Reduction of Mayo Score (Phase 2)
Proportion of patients with a reduction in Mayo Score
Time frame: At the end of week 4
Correlation between urinary and plasma nitrite, nitrate or nitrosothiol levels and fecal calprotectin
Comparison of biochemical levels with calprotectin
Time frame: Up to 4 weeks
Plan to share: No
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This study is withdrawn, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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