What side effects are associated with this type of intervention?

Common treatments for Ulcerative Colitis similar to Hydroxocobalamin (Vitamin B12) and Butyrate generally have mild side effects. Hydroxocobalamin can cause injection site reactions, dizziness, headache, and rarely, anaphylactic reactions. Butyrate may cause gastrointestinal discomfort, such as bloating and gas, particularly when first introduced. Both treatments are aimed at reducing inflammation and supporting gut health.

What prior FDA approvals exist?

The FDA has approved several treatments for Ulcerative Colitis that focus on reducing inflammation and supporting gut health. These include biologics like infliximab and adalimumab, which are anti-TNF agents that help reduce inflammation. Additionally, aminosalicylates such as mesalamine are commonly used to treat mild to moderate UC by reducing inflammation in the lining of the colon. Corticosteroids are also used for their potent anti-inflammatory effects, although they are typically reserved for short-term use due to side effects. While Hydroxocobalamin and Butyrate are not yet FDA-approved for UC, their anti-inflammatory properties and potential to support gut health are being explored in clinical trials.

What other types of research exist?

Promising novel alternatives for Ulcerative Colitis treatment in 2024 include: 1) Janus kinase (JAK) inhibitors like upadacitinib, which target specific pathways involved in inflammation; 2) S1P receptor modulators such as ozanimod, which help reduce lymphocyte migration to the gut; 3) Microbiome-based therapies, including fecal microbiota transplantation (FMT) and specific probiotic strains that aim to restore healthy gut flora; and 4) Biologics targeting different inflammatory pathways, such as IL-23 inhibitors (e.g., risankizumab). These alternatives are being actively researched and show promise in managing UC symptoms and inducing remission.

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Short Chain Fatty Acid

Hydroxocobalamin + Butyrate for Ulcerative Colitis (HARBOUR Trial)

Phase 2

Waitlist Available

Led By Joshua R Korzenik, MD

Research Sponsored by Joshua Korzenik

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with primary sclerosing cholangitis are eligible to enroll

Patients with a confirmed diagnosis of UC for > 3 months

Must not have

Congenital or acquired immunodeficiencies

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week 1-2 and at week 4

Summary

This trial tests vitamin B12 and a fatty acid to reduce gut inflammation in patients with ulcerative colitis. It aims to see if these treatments can lower a specific inflammation marker in the stool.

Who is the study for?

Adults aged 18-75 with confirmed ulcerative colitis (UC) for over 3 months, having significant colon involvement and active disease as shown by calprotectin levels. They must be able to consent and can take certain UC medications like mesalamine. Excluded are those with kidney stones, imminent colectomy, C. difficile or other colitis types, recent use of specific drugs including steroids and immune modulators, uncontrolled hypertension, severe liver or kidney issues, pregnancy/breastfeeding, cancer history within 5 years, immunodeficiencies or participation in another trial recently.

What is being tested?

The study tests if hydroxocobalamin combined with butyrate can lower calprotectin levels in UC patients compared to a placebo combined with butyrate. It's a short-term pilot study where participants are randomly assigned to either the treatment or placebo group without knowing which one they receive.

What are the potential side effects?

While not specified here, potential side effects may include allergic reactions to hydroxocobalamin or gastrointestinal discomfort from butyrate. As it is a trial assessing safety too, close monitoring will occur for any unexpected adverse effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have primary sclerosing cholangitis.

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I have been diagnosed with ulcerative colitis for more than 3 months.

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I am between 18 and 75 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a weakened immune system from birth or due to a condition.

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I haven't taken Vitamin C, prednisone, immune modulators, or anti-TNF agents in the last six weeks.

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I am likely to have surgery to remove part or all of my colon soon.

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My liver is not working properly.

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I am using treatments applied directly to my rectum.

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I have Crohn's Disease or my condition is possibly Crohn's.

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I have had kidney stones in the past.

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I have colitis caused by an infection or medication.

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I was diagnosed with cancer within the last 5 years.

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I have high blood pressure that is not well-controlled.

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My kidney function is reduced with a GFR under 60 mL/min.

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I have a history or risk of heart-related conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 1-2 and at week 4

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at week 1-2 and at week 4

This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 1-2 and at week 4 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from Baseline fecal calprotectin at week 4

Clinical Symptoms assessed by Simple Clinical Colitis Activity Index (SCCAI)

Incidence of Treatment-Emergent Adverse Events (AE) as assessed by Common Terminology Criteria for Adverse Events (CTCAE)

Secondary study objectives

Assessment of urinary and plasma nitrite, nitrate levels and nitrosothiol levels

Correlation between urinary and plasma nitrite, nitrate or nitrosothiol levels and fecal calprotectin

Normalization of fecal calprotectin below the upper limit of normal

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Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Hydroxocobalamin with ButyrateActive Control1 Intervention

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.

Group II: Placebo with ButyratePlacebo Group1 Intervention

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.

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Ulcerative Colitis (UC) work by targeting inflammation and supporting gut health. Hydroxocobalamin, a form of Vitamin B12, may reduce inflammation by modulating the immune response and decreasing oxidative stress. Butyrate, a short-chain fatty acid, has anti-inflammatory properties and supports gut health by nourishing colonocytes and maintaining the gut barrier. These mechanisms are crucial for UC patients as they address the core issues of inflammation and gut integrity. Other treatments like aminosalicylates, corticosteroids, immunomodulators, and biologics also aim to reduce inflammation and modulate the immune system, providing comprehensive management of the disease.

Probiotics for induction of remission in ulcerative colitis.