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A Phase 1b Trial to Evaluate the Safety of MB310 in Patients With Active, Mild-to-Moderate Ulcerative Colitis
Sponsor: Microbiotica Ltd
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
Conditions
Interventions
MB310
Live bacterial therapeutic for oral administration
Placebo
MB310-matching placebo for oral administration
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