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Study on EXL01 to Prevent Recurrence of C. difficile Infection in High-Risk Patients

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Clostridioides difficile infection, often referred to as C. difficile or CDI. This infection can cause severe diarrhea and other intestinal issues, and it is known for recurring in some patients. The study is particularly interested in patients who have experienced multiple recurrences of this infection. The treatment being tested is a new product called EXL01, which is a type of live biotherapeutic product. This means it contains live microorganisms that are intended to help restore the natural balance of bacteria in the gut. The study will also involve the use of Vancomycin, a medication commonly used to treat C. difficile infections.

The purpose of the study is to evaluate the safety and effectiveness of EXL01 in preventing the recurrence of C. difficile infection in patients who are at high risk of experiencing another episode. The study will be conducted in two phases. In the first phase, the focus will be on assessing how safe and tolerable EXL01 is for patients. In the second phase, the study will look at how well EXL01 works in preventing the infection from coming back. Participants will receive the treatment and be monitored over a period of time to see if the infection recurs and to check for any side effects.

Throughout the study, participants will be asked to take EXL01 in the form of a hard capsule, and they will continue their treatment with Vancomycin as prescribed. The study will involve regular check-ups to monitor the participants' health, the number of bowel movements, and the consistency of stools. The overall goal is to determine if EXL01 can effectively prevent future episodes of C. difficile infection, thereby improving the quality of life for those affected by this condition.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria, including age, previous episodes of Clostridioides difficile infection, and current or planned treatment with oral vancomycin.
Step 2
Phase I: safety and tolerability evaluation
During this phase, the focus is on evaluating the safety and tolerability of the oral EXL01 treatment. Monitoring for any serious adverse events is conducted.
The occurrence of any serious adverse events or discontinuation due to adverse events is recorded.
Step 3
Phase II: efficacy evaluation
This phase assesses the effectiveness of EXL01 in preventing the recurrence of Clostridioides difficile infection.
The primary endpoint is the proportion of patients who experience a recurrence of the infection, defined by specific symptoms and test results.
Step 4
Treatment and follow-up
Throughout the trial, patients receive oral EXL01 and are monitored for any adverse events.
Digestive symptoms are assessed at each visit, including the number of bowel movements, stool consistency, and abdominal discomfort.
Step 5
Quality of life assessment
Patient quality of life is evaluated at specific intervals using a validated questionnaire for digestive diseases.
Step 6
Microbiota analysis
The composition of the intestinal microbiota is analyzed at each visit using advanced sequencing techniques.
Step 7
Final evaluation
The trial concludes with a final evaluation of the treatment's impact on infection recurrence, patient quality of life, and microbiota composition.

Who can join the trial?

5 criteria

Patient must be over 18 years of age.
Patient must have experienced a 3rd episode of proven C. difficile infection within 6 months. This means having 3 or more liquid stools per day and detection of the bacteria in the stools using specific tests. The time between the end of treatment for the previous infection and the new episode should be 12 weeks or less.
Patient must be currently on or planning to start treatment with vancomycin taken by mouth.
Patient must be capable of giving free, informed, and written consent to participate in the study.
Patient must be enrolled in the national compulsory social security scheme.

Who cannot join the trial?

5 criteria

Patients who have not experienced multiple recurrences of Clostridioides difficile infection. This is a type of bacterial infection that affects the gut.
Patients who have not been treated with oral Vancomycin. Vancomycin is an antibiotic used to treat certain serious bacterial infections.
Patients who are not at high risk of recurrence of C. difficile infection. This means they are less likely to have the infection come back.
Patients who do not fall within the specified age range for the study. The study is open to certain age groups only.
Patients who are part of a vulnerable population. This refers to groups of people who may need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Assistance Publique Hopitaux De Marseille
Marseille, France
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Assistance Publique Hopitaux De Paris
Paris, France
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CHU Croix Rousse-Lyon
Lyon, France

Trial locations

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Investigated drugs

EXL01 is a new live biotherapeutic product being tested to prevent the recurrence of Clostridioides difficile infection in patients who are at high risk of experiencing another infection. This medication is taken orally and is designed to help maintain a healthy balance of bacteria in the gut, which may reduce the chances of the infection coming back. The trial aims to evaluate both the safety and how well patients tolerate this treatment, as well as its effectiveness in preventing future infections.

What is already known about the treatment

EXL01 – EXL01 is an investigational live biotherapeutic product administered orally. It is currently being evaluated in clinical trials for its safety, tolerability, and effectiveness in preventing the recurrence of Clostridioides difficile infection, particularly in patients at high risk of recurrence. The main therapeutic indication is to prevent multiple recurrences of this infection, which is often treated with oral Vancomycin. EXL01 works by introducing beneficial live microorganisms into the gut to restore a healthy balance of bacteria, potentially preventing harmful bacteria from causing infection. It falls under the pharmacological classification of probiotics or live biotherapeutic products.

Investigated diseases

Clostridioides difficile Infection – This infection is caused by the bacterium Clostridioides difficile, which can lead to inflammation of the colon. It often occurs after the use of antibiotics, which can disrupt the normal balance of bacteria in the gut. Symptoms typically include diarrhea, abdominal pain, and fever. The infection can recur multiple times, especially in individuals who have had it before. Recurrences are characterized by the return of symptoms such as frequent loose stools and abdominal discomfort. The condition is primarily spread through contact with contaminated surfaces or fecal matter.