LMN-201 for Prevention of C. Difficile Infection Recurrence

Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorLumen Bioscience, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • LMN-201
  • Placebo

Treatment groups

375 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Lumen Bioscience, Inc.

Lead sponsor

Congressionally Directed Medical Research Programs

Collaborator