Primary or Recurrent Clostridioides Difficile Infection Treatment With Capsules of Lyophilised Faecal Microbiota vs Fidaxomicin

PHASE3CompletedINTERVENTIONAL
Enrollment

93

Participants

Timeline

Start Date

October 29, 2021

Primary Completion Date

November 15, 2023

Study Completion Date

November 15, 2023

Conditions
Recurrent Clostridium Difficile InfectionPrimary Clostridium Difficile Infection
Interventions
BIOLOGICAL

MBK-01

A single dose of 4 capsules of MBK-01 (heterologous lyophilized fecal microbiota coming from healthy donors) orally.

DRUG

Fidaxomicin

Oral administration of 200mg/12 hours of fidaxomicin for 10 days.

Trial Locations (21)

14004

Hospital Universitario Reina Sofía, Córdoba

17007

Hospital Josep Trueta de Gerona, Girona

20014

Hospital Universitario de Donostia, Donostia / San Sebastian

26006

Hospital San Pedro, Logroño

28007

Hospital General Universitario Gregorio Marañón, Madrid

28034

Hospital Universitario Ramón y Cajal, Madrid

28041

Hospital Universitario 12 de Octubre, Madrid

28046

Hospital Universitario La Paz, Madrid

28222

Hospital Universitario Puerta de Hierro, Madrid

28223

Hospital Universitario Quirónsalud Madrid, Madrid

39008

Hospital Universitario Marqués de Valdecilla, Santander

46026

Hospital Universitario y Politécnico La Fe, Valencia

48013

Hospital Universitario de Basurto, Bilbao

48903

Hospital Universitario de Cruces, Barakaldo

50009

Hospital Clínico Universitario Lozano Blesa, Zaragoza

03010

Hospital General Universitario de Alicante, Alicante

08023

Hospital Quirónsalud Barcelona, Barcelona

08036

Hospital Clínic de Barcelona, Barcelona

08907

Hospital Universitario de Bellvitge, Barcelona

07120

Hospital Universitario Son Espases, Palma de Mallorca

01009

Hospital Universitario de Araba, Vitoria-Gasteiz

All Listed Sponsors
lead

Mikrobiomik Healthcare Company S.L.

INDUSTRY

NCT05201079 - Primary or Recurrent Clostridioides Difficile Infection Treatment With Capsules of Lyophilised Faecal Microbiota vs Fidaxomicin | Biotech Hunter | Biotech Hunter