Pfizer COVID-19 vaccine appointments are available to our patients. Sign up for Connect today to schedule your vaccination.

A randomized, double-blind, placebo-controlled study of LMN-201 for prevention of C. difficile infection recurrence (RePreve).

Clinical Trial Details

 The purpose of this study is to test if an investigational study drug, LMN-201, is safe and effective in treating patients with infection of the lower intestine (the colon) by bacteria called Clostridioides difficile (abbreviated C. difficile or C. diff). Individuals will be asked to be participants in this research study because they have developed an infection of their lower intestine (the colon) by bacteria called Clostridioides difficile (abbreviated C. difficile or C. diff).

Investigational means that the drug has not been approved by regulatory authorities such as the United States Food and Drug Administration (FDA). 
   
The standard treatment for this infection is with antibiotics, but in some people, the infection keeps coming back. The purpose of this research is to test whether an investigational drug can prevent a return of the infection. 

If an individual agrees to participate in this study (Part A), they will be asked to take a new study drug intervention (LMN-201) by mouth. The study drug intervention will be taken for 7 days, followed by 6 months of follow-up.

Study participants will complete electronic diaries and provide blood and stool samples. There are approximately 12 study visits.

Participation in this study will last for up to 12 visits and participants will be compensated for their time. 

Key Eligibility: 
  1. Men and women who are 18 years of age and older.
  2. Have been diagnosed with infection of Clostridioides difficile (abbreviated C. difficile or C. diff).

 Detailed eligibility will be reviewed when contacting the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2405027452

Sponsor:

CDI02

Status

Open to Enrollment

Age Group

Adult

Sponsor