RecruitingPhase 2/3

LMN-201 for Prevention of C. Difficile Infection Recurrence

United States375 participantsStarted 2024-08-29

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion 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 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.
✓. 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 antibiotic therapy is defined as the receipt of oral fidaxomicin or oral metronidazole or oral vancomycin (see Section 8.2.6)
✓. 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.

Exclusion criteria

✕. 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, pancreatic insufficiency, enteric parasitic infection, viral enteritis, bacterial enteritis (salmonella, shigella, ETEC, etc.).
✕. 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)

What they're measuring

Proportion of participants who achieve global cure

Timeframe: Up to 16 weeks after initiation of therapy

Trial details

NCT IDNCT05330182

SponsorLumen Bioscience, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06-01

Contact for this trial

Carl Mason

12068991904 trials@lumen.bio

View on ClinicalTrials.gov More Clostridioides Difficile Infection trials