Have you or a loved one recently contracted C. diff?

If so, consider joining the RePreve study, a clinical trial investigating a new potential drug to prevent reinfection of Clostridioides difficile (C. diff).

Find a study location near you!

Have you or a loved one recently contracted C. diff?

If so, consider joining the RePreve study, a clinical trial investigating a new potential drug to prevent reinfection of Clostridioides difficile (C. diff).

Find a study location near you!

What is the RePreve study?

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.

Who can join the RePreve study?

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.

What will happen during the study?

There are two parts to the RePreve study.

Participation in Part A

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:

Review & Sign the Informed Consent Form
The Informed Consent Form (ICF) contains information about the study including its goals, duration, benefits, risks, tests and procedures.
Study Treatment Period Part A: 1 week
Receive study drug twice daily (4 capsules in the morning, 4 capsules in the evening) for 7 days, administered orally, in addition to current antibiotic therapy prescribed by your doctor.
Observation Period: 4 weeks
All participants who receive at least 1 dose of the study drug will enter a 4-week observation phase. No study drug is administered during this period.  

Receive different study tests throughout this period to help the study doctor monitor your health and the effects of the study drug combination.  

Attend both in-person study visits and remote visits by phone during this period.
Follow-up Period: 22 weeks
Continued study health assessments for monitoring of health and effects of study drug combination.  

Attend your first follow-up visit in person, and complete remaining visits remotely.

Participation in Part B

in the RePreve study lasts approximately 9 months (38 weeks). Study participants can expect the following:

Review & Sign the Informed Consent Form
The Informed Consent Form (ICF) contains information about the study including its goals, duration, benefits, risks, tests and procedures.
Study Treatment Period Study: Up to 4 weeks
Assigned randomly to one of two treatment groups, either to receive active study drug or placebo.  

Take antibiotic therapy, as prescribed by your doctor, plus study drug, twice daily for a maximum of 28 days.
Prevention Period: 8 weeks *Part B only
Take study drug twice daily for 2 weeks after successful treatment.  

After two weeks, take study drug once daily for 6 additional weeks.  

*If you experience C. diff in treatment phase, you will skip the Prevention Period and begin the Observation Period.
Observation Period: 4 weeks
Attend study clinic visits in-person and remotely to monitor any sign of recurrent C. diff.
Follow-up Period: 22 weeks
Receive study health assessments for any sign of C. diff recurrence.

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.

Interested in the RePreve study?

Find a study location near you!

About the Study Drug

What is the study drug?

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.

Will I receive the study drug?

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.

What is an “investigational drug?”

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.

About Clostridioides difficile (C. diff)

What is C. diff ?

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)

Where can I learn more?

WebMDCDCMayo Clinic

Overview of Clinical Trials

Here are some common questions and answers about study participation.

If you have additional questions about participating in a clinical research study, contact a study clinic near you.

Study Clinic Locations

Find 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.

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