The ALDER Study is exploring whether a study drug can help prevent repeat infections in adults who have already gone through the ordeal of a C.diff infection. By joining this study, you could play a crucial role in research that might lead to better treatments for people facing this challenging condition.
You may be able to take part in the study if you:
- Are over the age of 18
- Currently have a C.diff infection with a positive C.diff test
- Are taking vancomycin to treat your current C.diff infection
In this study, researchers will be evaluating a potential new treatment for this serious and recurring infection.
Sign Up
What happens if I fill out the pre-screening questionnaire?
If you pass the initial study screener, we will match you to a study location in your area that needs volunteers with C.diff or notify you when one becomes available. If there is not a current study for C.diff in your area, a Patient Engagement Specialist may reach out to you in the future via the email address or phone number (call or text) you provided to share information about new study opportunities you may qualify for.
Keep in mind that participation is entirely voluntary. If you decide to take part in a study, you may change your mind about participating at any time.
About C.diff
Clostridioides difficile, commonly known as C.diff, is a type of bacteria that can cause inflammation in the colon, leading to a condition called C.difficile infection (CDI). It often results in symptoms such as severe diarrhea, abdominal pain, fever, and, in some cases, more serious complications like dehydration or damage to the intestines. While anyone can develop a C.diff infection, it is most common in individuals who have recently taken antibiotics or those with weakened immune systems, such as the elderly or hospitalized patients.1
C.diff bacteria are naturally found in the environment and can exist harmlessly in the human gut. However, when antibiotics disrupt the balance of healthy bacteria in the intestines, C.diff can grow unchecked and release toxins that damage the intestinal lining. The infection is highly contagious and spreads through contact with contaminated surfaces or by coming into contact with infected feces.2
Though C.diff can be treated with specific antibiotics, recurring infections are a challenge for many patients. Innovative research, like that conducted in clinical trials such as the ALDER Study, aims to discover more effective treatments and preventive measures to address the growing burden of this infection.
Frequently Asked Questions
What is a Clinical Research Study?
A Clinical Research study (also called a clinical trial) is a medical study that helps to answer important questions about an investigational drug – these may include how well an investigational study drug works for a certain condition. All medications must be tested in clinical research studies before they can be approved and prescribed to patients.
Why are Clinical Research Studies important?
A Clinical Research study is the process by which new and innovative medications, interventions and treatments are approved and brought to market, so people can live happier and healthier lives.
Several of these investigational medications are not yet available to the general public and can possibly help reduce your C.diff related symptoms as well as support other patients with C.diff.
Even over-the-counter medications, such as NSAIDs, you may have used to counteract a headache, have gone through the clinical research study process before it was available at your local pharmacy.
What else do I need to consider?
The research team will be able to explain more about what the ALDER Study will involve, and it is up to you to decide if you want to take part. Participation in this study is voluntary. Whether or not you decide to participate in this study will not affect your current or future relationships with your doctors. If you decide to participate, you are free to withdraw at any time without affecting those relationships.
How far is the study site?
We match you to a study site within a close travel distance from your home. If we are not running the study in your area currently, with your permission, we will keep you in our database and reach out once a study in your area becomes available. If, at any time, you decide you no longer want your information stored, you can opt out and we will delete your details.
About the ALDER Study
C.diff can cause severe gastrointestinal symptoms that disrupt daily life, and current treatment options don’t work for everyone. By participating in the Alder Study, you can help advance medical research and explore new ways to manage and treat C.diff.
The Alder Study will enroll about 80 participants at 25-30 study sites located throughout the United States, Poland, Spain, and Romania. The study will include visits to a study site located close to your home throughout the duration of the study. Study participation will last about 10 weeks, including a screening period, a 28-day study treatment or observation period, and a follow-up visit 4 weeks later.
During the screening period, you’ll have some tests and assessments to see if the study is a good fit for you. If you qualify, you’ll be randomly assigned either to receive the study drug or be part of a control group that will be observed but not receive study treatment. Tracking your bowel movements every day helps us gather crucial information about how well the study drug might be working. Throughout the study, our team will be right there with you, making sure you’re safe and comfortable.
There will be no extra costs to you when you join this study. Participants will receive all study-related care from a dedicated medical team. The study medicine and tests done for this study which are not part of your regular medical care will be provided at no cost to you. The parts of your care that would normally be done as standard treatment will be billed to you or your insurance company and you should check with your insurance company in this case.
You will be reimbursed for time, effort, and travel while in this research study and in accordance with the study or study site travel policy. This reimbursement might be handled by a separate vendor.
Who can take part in the ALDER Study?
You may be able to take part in the study if you:
- Are over the age of 18
- Are taking vancomycin to treat your current C.diff infection
- Currently have a C.diff infection with a positive C.diff test
In this study, researchers will be evaluating a potential new treatment for this serious and recurring infection.