| Eligibility |
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.
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