.png){kind=spacer}
The RePreve clinical research study is for people with a risk of C. diff reinfection. The study will test and evaluate a new investigational medication to determine whether treatment with LMN-201 (the investigative therapy) can prevent C. diff reinfection.
There are two parts to the RePreve study:
The purpose of Part A Sentinel Cohort is to determine the safety and tolerability of the study drug combination in people at higher risk of C. diff infections. All participants in Part A will receive the active study drug.
The purpose of Part B Main Cohort is to determine whether treatment with LMN-201 and your prescribed antibiotics prevent C. diff recurrence. The study drug is assigned at random, meaning you will either receive a placebo or the active study drug. The placebo looks like LMN-201 but contains no active ingredients. Neither you nor the study staff will know whether you receive the active study drug or placebo.
Study participants may be able to join the study if they meet the following requirements:
18 years or older
Confirmed recent diagnosis of C. diff
Taking or planning to take antibiotics for treatment of C. diff
No known allergy or sensitivity to corn or spirulina
Other study requirements will apply.
There are two parts to the RePreve study.
of the RePreve study lasts about 6 months (27 weeks) from completion of screening through last safety follow up. Study participants can expect the following:
in the RePreve study lasts approximately 9 months (38 weeks). Study participants can expect the following:
Participation in a clinical study is voluntary. You can ask any questions you have and may leave the study at any time, for any reason.
The investigational study drug, LMN-201, is a grouping of 4 individual proteins swallowed as capsules. The capsules hold proteins carefully grown in spirulina, a blue-green algae rich in nutrients when dried into an edible powder.
Protein 1: Comprised of 1 protein (endolysin), which targets and eliminates C. diff bacteria without harming the healthy, “good” bacteria in your digestive system.
Proteins 2-4: Comprised of 3 proteins that bind the toxin made by the “bad” C. diff bacteria that cause C. diff symptoms.
Participants in Part A will all receive the active study drug.
Participants in Part B will be randomized 1:1 to receive the active study drug or placebo.
This means half of participants in Part B will be assigned, at random, to receive the active study drug and half of participants will be assigned, at random, to receive placebo with no active ingredients. Neither you nor the study staff will know whether you receive the active study drug or placebo.
Investigational means the study medication is not approved by regulatory authorities like the US Food and Drug Administration (FDA), and it can only be used in clinical research studies like RePreve.
Clostridioides difficile (C. diff) is a bacterium that causes an infection in the colon, often leading to colitis (swelling of the colon) and diarrhea. C. diff often occurs in older adults in long-term care settings but can affect people of all ages taking antibiotics. The antibiotics unintentionally destroy good bacteria along with the bad bacteria, allowing for C. diff to dominate the colon.
About 1 in 4 people diagnosed with C. difficile infection will have it again in 2-8 weeks. With each new infection, the likelihood of reinfection strongly increases. Researchers are unsure why this occurs but suspect the same strain of C. diff bacteria lingers in the large intestine or a different strain of C. diff enters the body.
What we hope to discover from the RePreve study may help researchers and participants learn more about alternative therapies that can complement or even replace antibiotic usage for C. diff therapy.
Symptoms of C. diff may include:
Watery diarrhea
Mild stomach cramps
Loss of fluids (dehydration)
Inflammation of colon (colitis)
Here are some common questions and answers about study participation.
Clinical research studies, or trials, help scientists and doctors explore whether a medical strategy, device, or medication is safe and effective for people. Before any medication can be approved and made available to the public, it must go through several phases of clinical research.
Before enrolling in a clinical trial, you must sign an Informed Consent Form (ICF). The ICF contains information about the study, including study goals, how long the study will last, benefits and risks, and the tests and procedures you will receive.
Study participation usually involves visiting a clinic regularly, taking or receiving an investigational medicine, and having assessments to monitor your health. You can still see your regular doctor, but you should let them know that you are participating in a study.
Participation in clinical research studies is your choice, and you may stop at any time.
If you have additional questions about participating in a clinical research study, contact a study clinic near you.
Use the filters, map, and listing to find the study clinic closest to you. Contact the study clinic to learn more.