LMN-201 for Prevention of C. Difficile Infection Recurrence

Exclusion Criteria23

• 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)
• 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 in dose planned for the duration of the study.)
• 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 the study.
• Note: Use of probiotics and other food supplements (e.g., yogurt, kefir, kimchi, etc.) are not exclusionary.