Evaluation of EXL01, a New Live Biotherapeutic Product to Prevent Recurrence of Clostridioides Difficile Infection in High-risk Patients

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

May 7, 2024

Primary Completion Date

January 7, 2027

Study Completion Date

January 7, 2027

Conditions
Clostridioides Difficile InfectionRecurrent Infection
Interventions
DRUG

EXL01

"Following a at least 10-days vancomycin treatment :~Oral EXL01 including:~* 10 capsules per day in week 1 and 2~* 4 capsules per day, in weeks 3 and 4~* 1 capsule per day in weeks 5 to 8 Phase I : EXL01 during a 8 weeks open-label period"

DRUG

EXL01

"Following a at least 10-days vancomycin treatment :~Oral EXL01 including:~* 10 capsules per day in week 1 and 2~* 4 capsules per day, in weeks 3 and 4~* 1 capsule per day in weeks 5 to 8 Phase II: EXL01 during a 8 weeks double blind placebo-controlled period"

DRUG

Placebo

"Following a at least 10-days vancomycin treatment:~Oral placebo including:~* 10 capsules per day in week 1 and 2~* 4 capsules per day, in weeks 3 and 4~* 1 capsule per day in weeks 5 to 8 Phase II : Placebo during a 8 weeks double blind placebo-controlled period"

Trial Locations (9)

26000

NOT_YET_RECRUITING

Service de Maladies Infectieuses - CH de Valence, Valence

31059

NOT_YET_RECRUITING

Service de médecine interne - Pôle des maladies de l'appareil digestif - CHU de Toulouse, Toulouse

42100

NOT_YET_RECRUITING

Service d'infectiologie - Hôpital Nord / CHU Saint Etienne, Saint-Etienne

63003

NOT_YET_RECRUITING

Service d'hépato-gastroentérologie - CHU Estaing, Clermont-Ferrand

69004

RECRUITING

Service d'Hépato-gastroentérologie Hôpital de la Croix Rousse, Lyon

75012

RECRUITING

Service d'hépato-gastroentérologie - Hôpital Saint Antoine (APHP), Paris

Unknown

NOT_YET_RECRUITING

CH Annecy Genevois Service de Maladies infectieuses, Annecy

NOT_YET_RECRUITING

CHU Grenoble Service Maladies infectieuses et tropicales, Grenoble

NOT_YET_RECRUITING

APHM La Timone Service de Maladies infectieuses, Marseille

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Exeliom Biosciences

INDUSTRY

lead

Hospices Civils de Lyon

OTHER