Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ended
Participants planned
55
Countries
4
Sites
20
Ulcerative Colitis
Key facts
- Sponsor
- Microbiotica Limited
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 27 Sep 2024 → 9 Jan 2026
- Decision date (initial)
- 2024-08-19
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-507376-50-00
- WHO UTN
- U1111-1304-8241
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Ulcerative Colitis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10009900 | Colitis ulcerative | 100000004856 |
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Microbiotica Limited
- Sponsor organisation
- Microbiotica Limited
- Address
- The Newham Building, Chesterford Park, Little Chesterford Chesterford Park Little Chesterford
- City
- Saffron Walden
- Postcode
- CB10 1XL
- Country
- United Kingdom
Scientific contact point
- Organisation
- Microbiotica Limited
- Contact name
- Microbiotica Information
Public contact point
- Organisation
- Microbiotica Limited
- Contact name
- Microbiotica Information
Locations
4 EU/EEA countries · 20 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 15 | 4 |
| Bulgaria | Ended | 12 | 5 |
| Poland | Ended | 14 | 6 |
| Spain | Ended | 5 | 5 |
| Rest of world
United Kingdom
|
— | 9 | — |
Investigational sites
Medical University Of Vienna
Gastroenterology and Hepatology, Waehringer Guertel 18-20, Alsergrund, Vienna
Landeskrankenanstalten-Betriebsgesellschaft Kabeg
Gastroenterology, Hepatology, Endocrinology, Rheumatology and Nephrology, Feschnigstrasse 11, Klagenfurt,09.Bez.:Annabichl, Klagenfurt Am Woerthersee
Medizinische Universitaet Innsbruck
Gastroenterology and Hepatology, Anichstrasse 35, 6020, Innsbruck
Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH
Gastroenterology and Hepatology, Muellner Hauptstrasse 48, 5020, Salzburg
Acibadem City Clinic Tokuda University Hospital EAD
Clinic of Gastroenterology, Bulevard Nikola Yonkov Vaptsarov 51b, 1407, Sofiya
Diagnostics And Consultation Center Convex Ltd.
Not Applicable, Ulitsa Sinanishko Ezero 11a, 1680, Sofiya
Umbal - Prof. D-R Stoyan Kirkovich AD
Department of Gastroenterology, Ulitsa General Stoletov 2, 6003, Stara Zagora
Diagnostics-Consultancy Center Mladost M Varna OOD
Cabinet No. 604 - Gastroenterology, Bulevard Republika 15, 9020, Varna
Medical Center Rusemed EOOD
Cabinet 505, Floor 5, Bulevard Lipnik 123, Ruse
Medical Network Sp. z o.o.
WIP Warsaw IBD Point Profesor Kierkuś, Ul. Plowiecka 103, 04-501, Warsaw
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych I Administracji
Klinika Chorób Wewnętrznych i Gastroenterologii, Ul. Woloska 137, 02-507, Warsaw
Niepubliczny Zaklad Opieki Zdrowotnej Twoje Zdrowie El Sp. z o.o.
Poradnia gastroenterologiczna, Ul. Robotnicza 79, 82-300, Elblag
Korczowski Bartosz, Gabinet Lekarski
nd, ul. Litewska 4A/7, 35-302, Rzeszów
Centrum Medyczne Kermed Renata Bijata-Bronisz I Ewa Kowalinska Sp. j.
nd, Ul. Krolowej Jadwigi 16, 85-231, Bydgoszcz
Wojskowy Instytut Medyczny Panstwowy Instytut Badawczy
Klinika Gastroenterologii i Chorób Wewnętrznych, Ulica Szaserow 128, 04-141, Warsaw
Hospital Universitario Juan Ramon Jimenez
Digestive, Ronda Exterior Norte S/n, 21005, Huelva
Complexo Hospitalario Universitario De Vigo
Gastroenterology, Estrada Clara Campoamor N 341, 36312, Vigo
Centro Medico Teknon-Grupo Quironsalud
Gastroenterology, Calle Vilana 12, 08022, Barcelona
Parc Tauli Hospital Universitari
Digestive Diseases, Parc Del Tauli 1, 08208, Sabadell
Complexo Hospitalario Universitario De Santiago
Gastroenterology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2024-10-01 | 2026-01-07 | 2025-03-11 | 2025-07-17 | |
| Bulgaria | 2024-09-27 | 2026-01-07 | 2025-02-10 | 2025-07-17 | |
| Poland | 2024-10-04 | 2026-01-07 | 2024-10-15 | 2025-07-17 | |
| Spain | 2024-12-10 | 2026-01-08 | 2025-02-10 | 2025-07-17 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-19 | Austria | Acceptable 2024-08-12
|
2024-08-13 |
| 2 | SUBSEQUENT ADDITION OF MSC | APP-2 | 2024-09-05 | Acceptable 2024-08-12
|
2024-11-27 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-09-05 | Austria | Acceptable 2024-08-12
|
2024-09-05 |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-05 | Acceptable | 2024-10-14 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-06-26 | Austria | Acceptable 2025-08-07
|
2025-08-08 |