LMN-201 for Prevention of C. Difficile Infection Recurrence

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