NCT07469189

Brief Summary

We are planning a series of studies in individuals with ulcerative colitis, primary sclerosing cholangitis and pouchitis to determine if hydroxocobalamin is an effective therapy to treat these conditions. For these indications we are submitting INDs to the FDA as well as protocols to the IRB. Hydroxocobalamin, referred to as vitamin B12a has been approved by the FDA for treatment of cyanide toxicity in up to 5 grams intravenously over 15 minutes twice in a brief period. This has been tested and used in intravenous doses as high as 15 grams in a day. We will be utilizing its pharmacokinetic and safety profile to treat several subsets of patients. We are testing this initially in a healthy population to assess tolerability.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2023

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 13, 2026

Completed
Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

March 10, 2026

Last Update Submit

March 10, 2026

Conditions

Hydroxocobalamin Adverse Reaction

Outcome Measures

Primary Outcomes (1)

  • Adverse Events of Hydroxocobalamin Drug

    Stool consistency, stool frequency, Bristol Stool Chart score, GI symptoms

    2 weeks

Study Arms (1)

Hydroxocobalamin

EXPERIMENTAL
Drug: Hydroxocobalamin

Interventions

HydroxocobalaminDRUG

Hydroxocobalamin drug, or Vitamin B12a, generally used to treat cyanide toxicity.

Hydroxocobalamin

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Ages 18-70
  • Ability to give consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Interventions

Hydroxocobalamin

Intervention Hierarchy (Ancestors)

Vitamin B 12CorrinoidsTetrapyrrolesPyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingMacrocyclic CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Crohn's and Colitis Center

Study Record Dates

First Submitted

March 10, 2026

First Posted

March 13, 2026

Study Start

January 2, 2023

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

March 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)