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LMN-201 to prevent recurrence of C. difficile infections

A Phase 2, Randomized, Double-blind, Placebo-controlled Study of LMN-201 for Prevention of C. Difficile Infection Recurrence

Phase2; Phase3 Interventional Lumen Bioscience, Inc. · NCT05330182

This study is testing if a new treatment called LMN-201 can help prevent Clostridioides difficile infections from coming back in patients who are already being treated with antibiotics.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment375 (estimated)
Ages18 Years and up
SexAll
SponsorLumen Bioscience, Inc. Industry-sponsored
Drugs / interventionsBezlotoxumab
Locations16 sites (Escondido, California and 15 other locations)
Trial IDNCT05330182 on ClinicalTrials.gov

What this trial studies

This multisite clinical trial evaluates the safety, tolerability, and efficacy of LMN-201 in patients recently diagnosed with Clostridioides difficile infection (CDI) who are receiving standard of care antibiotic therapy. Participants will be administered either LMN-201 or a placebo while undergoing treatment for CDI. The study aims to determine if LMN-201 can effectively reduce the recurrence of CDI in these patients. The trial includes both Phase 2 and Phase 3 assessments to ensure comprehensive evaluation of the intervention.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 or older who have been recently diagnosed with CDI and are scheduled to receive standard antibiotic therapy.

Not a fit: Patients who have been diagnosed with CDI for more than 7 days or those not planning to receive antibiotic therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the recurrence of C. difficile infections, improving patient outcomes and quality of life.

How similar studies have performed: Other studies have explored treatments for CDI recurrence, but the specific approach of using LMN-201 is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Male or female, aged 18 or older.
2. 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 collected no more than 7 days before first dose of LMN-201/placebo), and no other likely explanation for diarrhea. NOTE: Diarrhea is not required to be present on the day of enrollment.
3. Provision of signed and dated informed consent form.
4. 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 antibiotic therapy is defined as the receipt of oral fidaxomicin or oral metronidazole or oral vancomycin (see Section 8.2.6)
5. May be on systemic antibiotics for an infection unrelated to the gastrointestinal tract.
6. Ability to take oral medication and willingness to adhere to the study medication regimen.
7. 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.
8. Access to a mobile smartphone.
9. 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 end of study drug administration.
10. 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 administration.

Exclusion Criteria:

1. Fulminant C. difficile colitis.
2. Admitted or expect to be admitted to an intensive care unit.
3. 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, pancreatic insufficiency, enteric parasitic infection, viral enteritis, bacterial enteritis (salmonella, shigella, ETEC, etc.).
4. Neutropenia (absolute neutrophil count of \< 1000 per microliter for any reason).
5. 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:

   1. Bezlotoxumab (Zinplava, Merck \& Co.), or another antibody against C. difficile toxin(s)
   2. C. difficile vaccine
   3. SER-109 (Seres Therapeutics)
   4. CP101 (Finch Therapeutics)
   5. VE303 (Vedanta Therapeutics)
   6. Fecal microbiota transplant
   7. Current therapy with oral exchange resins
   8. 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 in dose planned for the duration of the study.)
6. Treatment with SOC antibiotic therapy is planned for longer than a 28-day period.
7. Pregnancy, anticipated pregnancy, or breastfeeding.
8. Inability or unwillingness to swallow numerous, relatively large capsules containing study drug or placebo because of a swallowing disorder or dysphagia.
9. 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.
10. Psychiatric illness that would affect compliance with medications, study capsules, or follow-up.
11. Status as an inmate, residential mental health program, or residential substance abuse program.
12. Terminal illness with limited life expectancy of less than 24 weeks.
13. Poor concurrent medical risks with clinically significant co-morbid disease such that, in the opinion of the investigator, the patient should not be enrolled.
14. 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 the study.

    * 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.

Where this trial is running

Escondido, California and 15 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Clostridioides Difficile Infection
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.