NCT06582264

A Phase 1b Trial to Evaluate the Safety of MB310 in Patients With Active, Mild-to-Moderate Ulcerative Colitis

A Phase 1b, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Safety, Engraftment, and Initial Signs of Clinical Activity of MB310 in Patients With Active, Mild-to-Moderate Ulcerative Colitis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Microbiotica Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

A Phase 1b study to evaluate the safety and tolerability of MB310 given to patients who have active mild-to-moderate ulcerative colitis.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
BIOLOGICAL	MB310	Live bacterial therapeutic for oral administration
OTHER	Placebo	MB310-matching placebo for oral administration
DRUG	Vancomycin	Antibiotic

Timeline

• Start date: 2024-09-27
• Primary completion: 2026-01-08
• Completion: 2026-01-08
• First posted: 2024-09-03
• Last updated: 2026-02-17

Locations

18 sites across 4 countries: Austria, Bulgaria, Poland, United Kingdom