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Study identifier: NCT06306014 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Clostridioides Difficile Infection · Recurrent Infection  ·  Sponsor: Hospices Civils de Lyon

PhasePhase 1/Phase 2
Planned participants56
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

Clostridioides difficile infection (CDI) is the leading cause of nosocomial diarrhea in Europe, with over 120,000 cases and almost 3,700 deaths per year. This infection is characterized by a high risk of recurrence after cure, ranging from almost 20% after a first episode to over 60% after 2 recurrences, or in the case of specific risk factors. Currently, first-line treatment of CDI is based on oral antibiotics such as fidaxomicin or vancomycin. These antibiotic treatments, which are effective in 89% and 86% of first-episode cases respectively, do not correct the microbiological imbalance underlying the onset of CDI and may, on the contrary, encourage recurrence by contributing to the maintenance of a deleterious change in the microbiota (dysbiosis) through the elimination of bacteria other than C. difficile, due to their spectrum of activity. In a number of patients, this ecological imbalance can no longer be restored after antibiotic treatment, leading to multiple recurrences of CDI. In this context, fecal microbiota transplantation (FMT) has been validated for over 10 years for the prevention of recurrence in multi-recurrent CDI. The principle of FMT is based on the use of a pharmaceutical preparation made from the stool of a healthy donor, administered within the digestive tract of a patient for therapeutic purposes. Currently, in the case of multiple recurrences, it is the recommended first-line treatment (from 2 recurrences) and the most effective, with a clinical ef…

This description comes directly from the study's public registry record.

Talk to the study team

Nicolas BENECH, MD  ·  04 26 10 94 35  ·  nicolas.benech@chu-lyon.fr

Fanny JOUBERT  ·  04 26 73 27 27  ·  Fanny.joubert@chu-lyon.fr

Always discuss trial participation with your own doctor first.

Locations (10)

CH Annecy Genevois Service de Maladies infectieusesAnnecy, FranceNot Yet Recruiting
Service d'hépato-gastroentérologie - CHU EstaingClermont-Ferrand, FranceRecruiting
CHU Grenoble Service Maladies infectieuses et tropicalesGrenoble, FranceNot Yet Recruiting
CHU Lille Unité des Maladies Infectieuses et tropicalesLille, FranceNot Yet Recruiting
Service d'Hépato-gastroentérologie Hôpital de la Croix RousseLyon, FranceRecruiting
APHM La Timone Service de Maladies infectieusesMarseille, FranceRecruiting
Service d'hépato-gastroentérologie - Hôpital Saint Antoine (APHP)Paris, FranceRecruiting
Service d'infectiologie - Hôpital Nord / CHU Saint EtienneSaint-Etienne, FranceRecruiting
Service de médecine interne - Pôle des maladies de l'appareil digestif - CHU de ToulouseToulouse, FranceRecruiting
Service de Maladies Infectieuses - CH de ValenceValence, FranceRecruiting

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Source record: clinicaltrials.gov/study/NCT06306014