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

What Was Tested

The trial (phase 2) is built around Cyanocobalamin (Vitamin B12).

This is a 4-week pilot, multicenter, randomized, double-blinded placebo controlled trial of hydroxocobalamin and butyrate in ulcerative colitis (UC) that will occur in two phases.

It had two arms (groups): Hydroxocobalamin with Butyrate (active comparator) and Placebo with Butyrate (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Ability to give consent. Patients with a confirmed diagnosis of UC for \> 3 months. History of \> 15 cm of colonic involvement as confirmed by colonoscopy. Disease activity based on calprotectin \> 200. Allowed medications: mesalamine and sulfasalazine.

The full record lists 8 inclusion and 17 exclusion criteria; among the exclusions: history of uncontrolled hypertension with a systolic bp \> 140 and a systolic bp \> 90; impaired hepatic function (transaminases elevated \> 2.5 x uln) unless due to psc; evidence of c. difficile - negative test result within 1 month is acceptable to confirm.

How the Study Was Run

Design: randomized, sequential and double-blind.

Because people in this Cyanocobalamin (Vitamin B12) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Neither the participants nor the staff measuring them knew who was on Cyanocobalamin (Vitamin B12), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and care provider.

It started in 2024-01 with completion listed for 2025-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change from Baseline fecal calprotectin at week 4 (time frame: At baseline and at week 4). Incidence of Treatment-Emergent Adverse Events (AE) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) (time frame: Up to 4 weeks). Clinical Symptoms assessed by Simple Clinical Colitis Activity Index (SCCAI) (time frame: Up to 4 weeks).

It also tracked 4 secondary outcomes, for example Assessment of urinary and plasma nitrite, nitrate levels and nitrosothiol levels, Normalization of fecal calprotectin below the upper limit of normal and Correlation between urinary and plasma nitrite, nitrate or nitrosothiol levels and fecal calprotectin.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Cyanocobalamin (Vitamin B12) in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Cyanocobalamin (Vitamin B12) compound page, all human trials.