LMN-101 in a Campylobacter Human Challenge Model

Exclusion Criteria

• •1. Significant medical condition or laboratory abnormalities that in the opinion of the Principal Investigator preclude participation in the study.
• •2. History of Covid symptoms or positive Covid test within 2 weeks prior to admission date.
• •3. Alcohol or illicit drug abuse/dependency
• •4. Positive serology results for HIV, HBsAg, or HCV with confirmatory assays.
• •5. Pregnancy or breastfeeding
• •6. Personal or documented family history of Guillain-Barr syndrome or neuromuscular disease; or an inflammatory arthritis such as reactive arthritis, ankylosing spondylitis, or rheumatoid arthritis; inflammatory bowel disease; autoimmune disease; malignancy (not including basal cell carcinoma); any immunocompromising condition; or history of major gastrointestinal surgery.
• •7. Evidence of neurological abnormalities.
• •8. History of reactive arthritis or evidence of inflammatory arthritis on exam.
• •9. Fever within the 2 weeks prior to time of enrollment.
• •10. Evidence of IgA deficiency (serum IgA \< 7 mg/mL or below the limit of detection of assay).
• •11. HLA-B27 positive
• •12. Allergy or prior intolerance to two or more of the following antibiotics: azithromycin, ciprofloxacin, levofloxacin, erythromycin, ampicillin, or amoxicillin/clavulanate.
• •13. Allergy or prior intolerance to spirulina or spirulina products.
• •14. Fewer than 3 stools per week or more than 3 stools per day as the usual frequency.
• •15. History of moderate to serious diarrhea while traveling in a developing country within the last 3 years.
• •16. History of myocarditis or pericarditis.
• •17. History of major abdominal surgery or unexplained abdominal scar. Ok if appendectomy or cholecystectomy (one year post)
• •18. Regular use of antidiarrheal, antacids, loperamide, bismuth subsalicylate diphenoxylate, or similar medication affecting bowel motility (regular defined as at least weekly).
• •19. Use of proton pump inhibitors, H2 blockers, or other antacids within 48 hours preceding initiation of LMN-101 or placebo.
• •20. Use of antibiotics during the 7 days preceding initiation of LMN-101 or placebo.
• •21. Use of spirulina, or spirulina containing products, other than the study drug in the 30 days preceding initiation of LMN-101 or placebo.
• •22. Use of any investigational product within 30 days preceding initiation of LMN-101 or placebo or planned use during the active study period.
• •23. Use of any medication known to affect the immune system (e.g., systemic corticosteroids, chemotherapy, monoclonal antibody biologic response modifiers) within 12 months preceding initiation of LMN-101 or placebo or planned use during the active study period (excluding inhaled steroids with spacer).
• •24. History of prior exposure to Campylobacter including by vaccination or infection in previous trials, or serum immunoglobulin A (IgA) titer to C. jejuni glycine extract \>1:4000.
• •25. Other dietary or environmental exposures that may place the subject at high risk for prior Campylobacter exposure (to be determined on a case-by-case basis by the PI).
• •26. Employment as a food handler; childcare worker; or caregiver for elderly, immunocompromised individuals, or other at-risk population.
• •27. History of major mental illness such as schizophrenia, major depression or suicidal ideation
• •28. Any other criteria which, in the Principal Investigator's opinion, would compromise the ability of the subject to participate in the study, the safety of the study or the results of the study.
• •29. Potential participant's 12 - lead electrocardiogram demonstrating pathologic abnormalities including non-sinus rhythm, pathologic Q waves, significant ST-T wave changes, corrected QT interval (QTc) using Fridericia correction (QTcF) at screening and Day -1 (admission) \>450 msec.
• •30. At screening, systolic blood pressure \>140 mm Hg or diastolic blood pressure \>90 mm Hg.