| Eligibility |
Inclusion Criteria:
1. Male or non-pregnant female between 18 and 50 years of age, inclusive, at time of
informed consent
2. Willingness to participate after written informed consent obtained
3. Available for all planned clinical visits (for physical examinations, blood draws, and
stool collections) and follow-up monitoring (9 or 10 clinic visits and 1 phone
interview 6 months post-challenge)
4. Agreement to follow the restrictions of the study. Willing and able to follow the
study directions and procedures, including the rules and procedures of the clinical
research unit.
5. Demonstrated comprehension of the protocol procedures including knowledge of
Campylobacter illness by passing a written examination (passing grade = 70%).
6. General good health, without significant medical illness or abnormal physical
examination findings as determined by the PI.
7. Laboratory values are Grade 1 or lower using the Common Terminology Criteria for
Adverse Events (CTCAE) Version 5.0 as defined below:
1. Absolute neutrophil count = 1500/µL
2. Lymphocyte count = 800/µL
3. Platelet count = 125,000/µL
4. Hemoglobin = 13.0 g/dL in males (= 11.0 g/dL in females)
5. Serum creatinine =1.5x ULN
6. ALT and/or AST = 1.5x ULN
7. Total bilirubin = 1.5x ULN
8. Females of childbearing potential must commit to use one of the following highly
effective methods of birth control consistently for at least 1 month prior to
screening through study completion:
1. Stable hormonal contraception with inhibition of ovulation; or
2. Intrauterine device (IUD); or
3. Bilateral tubal occlusion; or
4. Surgical sterilization (vasectomy) of male partner at least 6 months prior to
study; or
5. Sexual abstinence (inactivity).
9. To be considered of non-childbearing potential, females should be surgically
sterilized (bilateral tubal ligation, hysterectomy, or bilateral oophorectomy at least
2 months prior to study) or be post-menopausal and at least 1 year since menses with
follicle-stimulating hormone = 40 units.
10. Males should use condoms for contraception and refrain from donating sperm through Day
64.
11. BMI between 18.5 and 33.5 inclusive
12. Complies with current Pharmaron Covid-19 policies and procedures
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.
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