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Prevention study for Clostridioides Difficile Infection
Official title LMN-201 for Prevention of C. Difficile Infection Recurrence
ClinicalTrials.gov ID: NCT05330182
What this study is testing
What is LMN-201?
LMN-201 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for clostridioides difficile infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multisite study to evaluate the safety, tolerability, and efficacy of LMN-201 in participants recently diagnosed with CDI who are scheduled to receive or are receiving SOC antibiotic therapy against C. difficile.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female, aged 18 or older.
- Diagnosis of CDI defined as a new or recent history of 3 or more bowel movements per day with a loose or watery consistency (Bristol Stool Scale 5...
- Provision of signed and dated informed consent form.
- Scheduled to receive or planning to receive a ≤28-day course of SOC antibiotic therapy for CDI. Participant must have been diagnosed with CDI for 7...
- May be on systemic antibiotics for an infection unrelated to the gastrointestinal tract.
You likely can't join if
- Fulminant C. difficile colitis.
- Admitted or expect to be admitted to an intensive care unit.
- Underlying gastrointestinal disorder characterized by diarrhea including but not limited to chronic ulcerative colitis, Crohn's disease, celiac...
- Neutropenia (absolute neutrophil count of \< 1000 per microliter for any reason).
- Current or previous treatment in past 3 months with any therapy likely to influence the outcome of this study, including but not limited to the...
- Bezlotoxumab (Zinplava, Merck \& Co.), or another antibody against C. difficile toxin(s)
See the full eligibility criteria
- Male or female, aged 18 or older.
- Diagnosis of CDI defined as a new or recent history of 3 or more bowel movements per day with a loose or watery consistency (Bristol Stool Scale 5, 6, or 7); a positive stool C. difficile toxin B immunoassay (stool...
- Provision of signed and dated informed consent form.
- Scheduled to receive or planning to receive a ≤28-day course of SOC antibiotic therapy for CDI. Participant must have been diagnosed with CDI for 7 or fewer days at time of initial study drug administration. SOC...
- May be on systemic antibiotics for an infection unrelated to the gastrointestinal tract.
- Ability to take oral medication and willingness to adhere to the study medication regimen.
- Stated willingness and ability to comply with all study procedures and availability for the duration of the study and investigator believes individual will complete the study.
- Access to a mobile smartphone.
- For females of reproductive potential: use of highly effective contraception for at least 4 weeks prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the...
- For males of reproductive potential: agreement to use condoms or other methods to ensure effective contraception with partner during study participation and for an additional 4 weeks after the end of study drug...
- Fulminant C. difficile colitis.
- Admitted or expect to be admitted to an intensive care unit.
- Underlying gastrointestinal disorder characterized by diarrhea including but not limited to chronic ulcerative colitis, Crohn's disease, celiac sprue, short bowel syndrome, dumping syndrome following gastrectomy...
- Neutropenia (absolute neutrophil count of \< 1000 per microliter for any reason).
- Current or previous treatment in past 3 months with any therapy likely to influence the outcome of this study, including but not limited to the following:
- Bezlotoxumab (Zinplava, Merck \& Co.), or another antibody against C. difficile toxin(s)
- C. difficile vaccine
- SER-109 (Seres Therapeutics)
- CP101 (Finch Therapeutics)
- VE303 (Vedanta Therapeutics)
- Fecal microbiota transplant
- Current therapy with oral exchange resins
- Protracted exposure to mu-agonist opioids and/or anticholinergic medication prescribed for diarrheal symptoms (unable to stop mu-agonist opioid treatment unless on a stable dose as of onset of diarrhea and no increase...
- Treatment with SOC antibiotic therapy is planned for longer than a 28-day period.
- Pregnancy, anticipated pregnancy, or breastfeeding.
- Inability or unwillingness to swallow numerous, relatively large capsules containing study drug or placebo because of a swallowing disorder or dysphagia.
- Inability to pass swallowed capsules into the distal small intestine because of gastroparesis, repetitive vomiting, or anatomic narrowing in the esophagus, stomach, or small intestine.
- Psychiatric illness that would affect compliance with medications, study capsules, or follow-up.
- Status as an inmate, residential mental health program, or residential substance abuse program.
- Terminal illness with limited life expectancy of less than 24 weeks.
- Poor concurrent medical risks with clinically significant co-morbid disease such that, in the opinion of the investigator, the patient should not be enrolled.
- Any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of the individual, would make it unlikely for the individual to complete the study, or would confound the results of...
- Note: Use of probiotics and other food supplements (e.g., yogurt, kefir, kimchi, etc.) are not exclusionary.
- Note: Assuming participants meet all of the inclusion criteria and none of the exclusion criteria, participants with underlying malignancy with a good life expectancy in the study are not excluded.
The study team makes the final eligibility decision.
Where it's taking place
- Escondido, California, United States
- Bridgeport, Connecticut, United States
- Hamden, Connecticut, United States
- Naples, Florida, United States
- Decatur, Georgia, United States
- Idaho Falls, Idaho, United States
- Burr Ridge, Illinois, United States
- Oak Lawn, Illinois, United States
- Lexington, Kentucky, United States
- Minneapolis, Minnesota, United States
- Butte, Montana, United States
- Omaha, Nebraska, United States
- New York, New York, United States
- Mount Airy, North Carolina, United States
- Houston, Texas, United States
- Annandale, Virginia, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Escondido, California, United States; Bridgeport, Connecticut, United States; Hamden, Connecticut, United States; Naples, Florida, United States; Decatur, Georgia, United States; Idaho Falls, Idaho, United States and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.