A Study on Hydroxocobalamin Given to Healthy Individual to Monitor Symptoms (Shrimp)

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.

Study Overview

• Status: Completed
• Conditions: Hydroxocobalamin Adverse Reaction
• Intervention / Treatment: Drug: Hydroxocobalamin

Detailed Description

Patients will be recruited at Brigham and Women's Hospital (BWH), at both the main campus and 850 Boylston Street locations. Healthy subjects may be identified as family members of patients who are picking them up from colonoscopy procedures or through the Mass General Brigham Rally system. Flyers and emails will inform interested subjects of the trial and will assist with recruitment.

Patients may be identified by their physician or by a research coordinator with physician permission. Patients identified by their healthcare providers who may meet entry criteria would be approached by a study team member to explain about the trial in more detail and to offer participation. In collaboration with their physician, the patient will decide whether to consent and participate.

We aim to enroll up to 10 individuals for the study. Individuals will be requested to maintain their diets in their usual intake and avoid those foods which they are aware that may induce diarrhea or looser stools for them.

Patients will be given different oral doses of hydroxocobalamin to assess tolerability.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hydroxocobalamin	Drug: Hydroxocobalamin; Hydroxocobalamin drug, or Vitamin B12a, generally used to treat cyanide toxicity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events of Hydroxocobalamin Drug	Stool consistency, stool frequency, Bristol Stool Chart score, GI symptoms	2 weeks

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2023
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: March 10, 2026
• First Submitted That Met QC Criteria: March 10, 2026
• First Posted (Actual): March 13, 2026

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, Fused-Ring; Azoles; Polycyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Pyrroles; Macrocyclic Compounds; Tetrapyrroles; Corrinoids; Vitamin B 12; Hydroxocobalamin
• Other Study ID Numbers: 2022P003028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No