Actively Recruiting
Evaluation of EXL01, a New Live Biotherapeutic Product to Prevent Recurrence of Clostridioides Difficile Infection in High-risk Patients
Led by Hospices Civils de Lyon · Updated on 2026-05-15
56
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
Sponsors
H
Hospices Civils de Lyon
Lead Sponsor
E
Exeliom Biosciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
Clostridioides difficile infection (CDI) is a leading cause of hospital-acquired diarrhea in Europe, causing over 120,000 cases and nearly 3,700 deaths annually. This infection often recurs, especially after multiple episodes, with recurrence rates rising to over 60% in patients with two or more prior episodes or certain risk factors. Current first-line treatments involve oral antibiotics such as fidaxomicin or vancomycin, which are effective but can disrupt the gut microbiota and may contribute to recurrence by allowing harmful bacterial imbalances to persist. Fecal microbiota transplantation (FMT) has been validated as a preventive treatment for multiple recurrent CDI by restoring healthy gut bacteria. This Phase I/II trial evaluates the safety and efficacy of EXL01, an oral live biotherapeutic product consisting of a single strain of the beneficial bacterium Faecalibacterium prausnitzii. The study includes two parts: Phase I involves 6 patients receiving open-label EXL01 for 8 weeks, while Phase II randomizes 50 patients to either EXL01 or placebo for an 8-week double-blind period. Participants receive EXL01 or placebo capsules daily following at least 10 days of vancomycin treatment, with dosing starting at 10 capsules per day for the first two weeks, then tapering down to 1 capsule daily by weeks 5 to 8. Participants will be monitored for recurrence of CDI and treatment safety for up to 16 weeks. Assessments include stool frequency and consistency, abdominal discomfort, quality of life, and the presence and persistence of EXL01 and toxigenic C. difficile in stool samples. Researchers will track treatment-emergent adverse events at multiple time points and evaluate the primary outcome of CDI recurrence prevention at week 8. The study aims to understand if EXL01 can reduce CDI recurrence in high-risk patients while monitoring overall safety and tolerability.
CONDITIONS
Brief Title
Evaluation of EXL01, a New Live Biotherapeutic Product to Prevent Recurrence of Clostridioides Difficile Infection in High-risk Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patient 18 years of age or older
- At least 3rd episode of confirmed Clostridioides difficile infection within 6 months with specific risk factors, or 2nd episode with risk factors such as age 70 or older, chronic renal failure, history of severe CDI, multiple CDI episodes in last 12 months, or recent hospitalization
- Currently on or planned oral vancomycin treatment
- Able to provide free, informed, and written consent
- Enrolled in compulsory national social security scheme
You will not qualify if you...
- Participation in another investigational study within 3 months prior to first dose
- Severe or complicated current Clostridioides difficile infection
- Refractory CDI with lack of response to oral vancomycin or fidaxomicin
- Cirrhosis with Child C score
- Hospitalization in continuing care or intensive care unit
- Immunosuppression including certain cancers, HIV/AIDS, recent stem cell transplant, aplasia, or high-dose prednisone treatment
- History of major gastrointestinal surgery other than appendectomy
- Small intestinal microbial overgrowth
- Inflammatory bowel disease
- Proven celiac disease
- Current or recent stoma or intra-abdominal surgery
- Major surgery or trauma within 4 weeks before treatment
- Antibiotic therapy for infection other than CDI during study
- Scheduled surgery requiring perioperative antibiotics
- Women without contraception, pregnant, or breastfeeding
- Hypersensitivity to EXL01 components or vancomycin
- Fecal microbiota transplantation within last 12 months
- Persons deprived of liberty or under legal protection
- Swallowing disorders preventing oral treatment
- Expected life expectancy less than 6 months
- Psychiatric disorders interfering with study cooperation
- Regular use of illicit or recreational drugs
- Planned treatments causing diarrhea during study
- History of chronic diarrhea unrelated to infection
- Other medical or surgical conditions interfering with study participation or safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive oral EXL01 or placebo following at least 10 days of vancomycin treatment, with doses varying over an 8-week period.
Visits at Week 1, Week 2, Week 4, and Week 8
Duration - 8 weeks
Participants are monitored for safety, recurrence of infection, and quality of life after treatment ends.
Visits at Week 16
Trial Site Locations
Total: 9 locations
1
CH Annecy Genevois Service de Maladies infectieuses
Annecy, France
Not Yet Recruiting
2
Service d'hépato-gastroentérologie - CHU Estaing
Clermont-Ferrand, France, 63003
Actively Recruiting
3
CHU Grenoble Service Maladies infectieuses et tropicales
Grenoble, France
Not Yet Recruiting
4
Service d'Hépato-gastroentérologie Hôpital de la Croix Rousse
Lyon, France, 69004
Actively Recruiting
5
APHM La Timone Service de Maladies infectieuses
Marseille, France
Actively Recruiting
6
Service d'hépato-gastroentérologie - Hôpital Saint Antoine (APHP)
Paris, France, 75012
Actively Recruiting
7
Service d'infectiologie - Hôpital Nord / CHU Saint Etienne
Saint-Etienne, France, 42100
Not Yet Recruiting
8
Service de médecine interne - Pôle des maladies de l'appareil digestif - CHU de Toulouse
Toulouse, France, 31059
Actively Recruiting
9
Service de Maladies Infectieuses - CH de Valence
Valence, France, 26000
Actively Recruiting
Research Team
N
Nicolas BENECH, MD
F
Fanny JOUBERT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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