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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week 1-2 and at week 4

Awards & highlights

HARBOUR Trial Summary

This trial will test whether hydroxocobalamin and butyrate can reduce inflammation in people with ulcerative colitis. The trial will occur in two phases, and safety and dosage of the drugs will be determined.

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.Check my eligibility

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.See study design

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.

HARBOUR Trial 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.

HARBOUR Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

+1 more

HARBOUR 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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Joshua KorzenikLead Sponsor

Joshua R Korzenik, MDPrincipal InvestigatorBrigham and Women's Hospital

1 Previous Clinical Trials

42 Total Patients Enrolled

Media Library

Butyrate (Short Chain Fatty Acid) Clinical Trial Eligibility Overview. Trial Name: NCT04259060 — Phase 2

Ulcerative Colitis Research Study Groups: Placebo with Butyrate, Hydroxocobalamin with Butyrate

Ulcerative Colitis Clinical Trial 2023: Butyrate Highlights & Side Effects. Trial Name: NCT04259060 — Phase 2

Butyrate (Short Chain Fatty Acid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04259060 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many test subjects are being used in this research?

"Unfortunately, this study is no longer looking for participants. The posting date was January 1st 2023 and the most recent update was March 4th 2022. If you are still interested in participating in medical trials, there are 425 other studies currently recruiting patients with ulcerative colitis and 9 different studies testing Hydroxocobalamin with Butyrate that need participants."

Answered by AI

Does this test have an age limit? Can octogenarians still participate?

"The age range for potential participants in this trial is 18 to 75 years old."

Answered by AI

Are there any available openings for subjects in this clinical trial?

"Unfortunately, this particular clinical trial is not presently recruiting patients. Although it was first posted on 1/1/2023 and last edited more recently on 3/4/2022, there are 434 other trials that are currently enrolling candidates."

Answered by AI

Are there any health risks associated with taking Hydroxocobalamin with Butyrate?

"Because there is some data supporting safety but none yet for efficacy, we have given Hydroxocobalamin with Butyrate a score of 2."

Answered by AI

Who meets the requirements to participate in this research project?

"The eligibility requirements for this clinical trial include a diagnosis of ulcerative colitis and being between 18-75 years old. A maximum of 42 people will be enrolled in the study."

Answered by AI

What ailments has Hydroxocobalamin with Butyrate shown to be the most effective?

"Hydroxocobalamin with Butyrate is most often used to heal burn patients, but it can also be given as treatment for other conditions such anemia, vitamin deficiency, and pernicious behavior disorders."

Answered by AI

Are there other examples in the medical literature of Butyrate being used with Hydroxocobalamin?

"Currently, there are 9 active clinical trials worldwide testing the efficacy of Hydroxocobalamin with Butyrate. 2 of those studies have reached Phase 3. Many of the ongoing trials for this treatment are based in Milwaukee, Wisconsin; however, research is being conducted at 16 different sites."

Answered by AI

What goals does this research aim to achieve?

"The primary outcome of this study is a change in baseline fecal calprotectin levels at week 4. This will be monitored through regular testing. Secondary outcomes include the correlation between urinary, plasma nitrite, nitrate or nitrosothiol levels and fecal calprotectin levels. Another secondary outcome is the comparison of biochemical levels with calprotectin. The last secondary outcome is the assessment of urinary and plasma nitrite, nitrate levels and nitrosothiol levels at baseline to week 1-2 and week 4."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Joshua Korzenik 2024. "Hydroxocobalamin Approach for Reducing of Calprotectin With Butyrate for Ulcerative Colitis Remission". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04259060.

All > Ulcerative Colitis > Colitis