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COMPLETED
NCT06582264
PHASE1

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

Sponsor: Microbiotica Ltd

View on ClinicalTrials.gov

Summary

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

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

29

Start Date

2024-09-27

Completion Date

2026-01-08

Last Updated

2026-06-15

Healthy Volunteers

No

Interventions

BIOLOGICAL

MB310

Live bacterial therapeutic for oral administration

OTHER

Placebo

MB310-matching placebo for oral administration

DRUG

Vancomycin

Antibiotic

Locations (22)

Medizinische Universitaet Innsbruck

Innsbruck, Austria

Klinikum Klagenfurt am Woerthersee

Klagenfurt, Austria

Uniklinikum Salzburg

Salzburg, Austria

Medizinische Universitaet Wien

Vienna, Austria

Acibadem City Clinic, Tokuda Hospital

Sofia, Bulgaria

Diagnostic Consulting Center Convex EOOD

Sofia, Bulgaria

Medical Center Rusemed EOOD

Sofia, Bulgaria

University Multiprofile Hospital for Active Treatment

Stara Zagora, Bulgaria

Diagnostic-Consulting Center

Varna, Bulgaria

Centrum Medyczne Kermed

Bydgoszcz, Poland

Korczowski Bartosz, Gabinet Lekarski

Rzeszów, Poland

Panstwowy Instytut Medyczny MSWiA - Klinika Gastroenterologi i Chorob Wewnetrznych

Warsaw, Poland

Warsaw IBD Point

Warsaw, Poland

Wojskowy Instytut Medyczny - Panstwowy Instytut Badawczy, Klinika Gastroenterologii i Chorob Wewnetrznych

Warsaw, Poland

Centro Medico Teknon

Barcelona, Spain

Hospital Universitario Juan Ramon Jimenez

Huelva, Spain

Corporacio Sanitaria Parc Tauli - Hospital de Sabadell

Sabadell, Spain

Hospital Clinico Universitario de Santiago

Santiago de Compostela, Spain

Hospital Alvaro Cunqueiro

Vigo, Spain

University Hospital Birmingham

Birmingham, United Kingdom

Addenbrooke's Hospital

Cambridge, United Kingdom

St George's Hospital

London, United Kingdom