Evaluation of the Oral Live Biotherapeutic EXL01 to Prevent Recurrence of Clostridioides Difficile Infection in Adults at High Risk

What this Trial Is About

Clostridioides difficile infection CDI is a common cause of hospital-acquired diarrhea in Europe, with a high risk of recurrence after treatment. The trial focuses on preventing these recurrences in high-risk adults by studying a new live biotherapeutic product called EXL01, a strain of the gut bacterium Faecalibacterium prausnitzii. This bacterium is often diminished in CDI patients and is linked to better treatment outcomes and reduced recurrence risk. The study involves two parts Phase I open-label treatment of 6 patients and Phase II randomized, double-blind, placebo-controlled treatment of 50 patients. All participants receive oral capsules of either EXL01 or placebo following at least 10 days of vancomycin treatment. Dosage starts with 10 capsules daily for the first two weeks, then decreases over weeks 3 to 8. The Phase II part compares EXL01 against placebo to assess efficacy and safety. Participants will be monitored over 16 weeks with evaluations including stool frequency and consistency, abdominal discomfort, quality of life, and microbiota analysis. Researchers will assess recurrence of CDI, presence and persistence of EXL01 in the gut, and adverse events. The study measures treatment safety and effectiveness in reducing CDI recurrence among high-risk patients receiving the study drug or placebo.

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