About 1 in 5 patients who get C. difficile will get it again.1
The CONSORTIUM Study is testing the safety and effectiveness of an investigational drug called VE303 which is a combination of bacteria given in an oral capsule. The bacteria, found in the gut microbiome of healthy individuals, can help to suppress the growth of C. difficile bacteria.
You may be eligible to take part in The CONSORTIUM Study if you:
All study-related care will be provided by qualified medical professionals.
Clostridioides difficile is a bacterium that causes diarrhea and colitis, which is estimated to cause over half a million illnesses in the USA each year.2
In recent years, there has been a rise in C. diff infections. C. diff infections have also become more severe and difficult to treat.3 C. diff usually affects adults older than 60, individuals living in long-term care homes, and/or people who recently received antibiotic treatment. However, there have been studies that show an increase in C. diff within younger, otherwise healthy individuals.
C. diff is a bacterium that is found in the air, soil, water, feces and even in some of the food we consume. C. diff is often found in long-term care homes or hospitals, where a higher percentage of people carry the bacteria. C. difficile infections have been associated with the use of antibiotics, which affect the gut/body microbiome—the different types of bacteria found within and on your body (i.e. gut, mouth, skin). Bacteria can be harmful (i.e. causes of infection) or protective (helps aid your immune system to keep you healthy). Antibiotics can rid the body of bacteria present in your microbiome, which includes the protective bacteria. When the microbiome is altered, it can leave you more vulnerable to certain types of bacterial infections, C. difficile being one of them. C. difficile bacteria can change and evolve, which can potentially lead to recurrence of infection if not effectively treated by standard antibiotic therapies.
The symptoms of C. diff may range from mild to severe. Symptoms usually develop 5 to 10 days after starting a course of antibiotics, or within the month following antibiotic treatment.
These symptoms can include:
A Clinical research study (also called a clinical trial) is a medical study that helps to answer important questions about an investigational drug or device, such as: Does the treatment work or how effective it is compared to another drug/device?
Your participation in this study will last about 24 weeks. The study will include 5 visits to a study clinic in your area and follow up phone calls at designated times.
At visits, you will undergo general physical examination procedures to assess your wellbeing (e.g. height, weight, blood pressure). The study will also require that a stool sample is taken prior to starting antibiotics for treatment of the current C. Diff infection.
All study-related care is provided at no cost to you. You do not need health insurance to participate.
Volunteers who take part in the study may receive up to $350 compensation for their time and travel.
Participation is entirely voluntary. Even if you decide to take part in this study, you change your mind about participating at any time.
What happens if I Sign Up? If you sign up, we will match you to a study clinic in your area that is actively enrolling participants or notify you when a site near you opens. Once the site receives your information, they will contact you to further explain the study before you make your decision about participating. You will attend an in-person visit where the study team will help determine if you qualify for the study, and if the study is right for you.
If you think you might like to join the CONSORTIUM Study or would like more information, please enter your information below so we can see if you qualify and can contact you about the study.
Study participation is entirely voluntary. Even if you decide to take part in this study, you change your mind about participating at any time.