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Vitamin B12a safety check: first step toward new gut disease treatments?

NCT ID NCT07469189

Knowledge-focused Sponsor: Brigham and Women's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed Phase 1 study gave hydroxocobalamin (a form of vitamin B12a) to 10 healthy adults to see how well it is tolerated. The goal was to gather safety and symptom data before testing the drug in people with ulcerative colitis, primary sclerosing cholangitis, or pouchitis. Researchers monitored stool consistency, frequency, and other GI symptoms.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
hydroxocobalamin (vitamin B12a)
What this could lead to
If this initial safety study succeeds, it could pave the way for testing hydroxocobalamin as a treatment for ulcerative colitis, primary sclerosing cholangitis, and pouchitis.
What could go wrong
This is a very early Phase 1 study with only 10 healthy participants, so results may not predict effectiveness in patients with GI diseases. The drug is being repurposed, and its safety for these new uses is not yet known.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

10 people

The number who actually took part.

Started

Jan 2023

Finished

Jun 2023

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Ages 18-70 * Ability to give consent Exclusion Criteria: * Patients who are pregnant or breastfeeding * Use of chronic medications * History of hypersensitivity to hydroxocobalamin * History of chronic constipation or diarrhea * History of IBS or other GI illness which causes symptoms of diarrhea or constipation

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hydroxocobalamin adverse reaction

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States