LMN-101 in a Campylobacter Human Challenge Model (NCT04182490) | Clinical Trial Compass
CompletedPhase 2
LMN-101 in a Campylobacter Human Challenge Model
United States42 participantsStarted 2022-02-21
Plain-language summary
Randomized, double-blind, placebo-controlled, single dose regimen study of LMN-101 followed by Campylobacter jejuni challenge. Subjects will initially, after documentation of informed consent, begin taking their assigned LMN-101 or placebo regimen three times daily. After two days, subjects will receive the C. jejuni challenge inoculum. Subjects will begin an appropriate antibiotic course upon meeting early treatment criteria or 144 hours following C. jejuni challenge, whichever is earlier. Subjects will be allowed to leave the clinical research facility 3 days after antibiotics, when all symptoms have resolved or are resolving, and have had ≥ 2 consecutive stool cultures ≥ 12 hours apart negative for C. jejuni and are afebrile \> 24 hours prior to release and off antipyretics within 24 hours of discharge. Subjects will continue taking their LMN-101 or placebo regimen three times daily for a total of 14 days. Subjects will be provided a diary card/memory aid and thermometer for at-home monitoring of solicited adverse events through Day 24. Subjects will be seen at research facility for protocol-specified evaluations and will also be contacted by telephone 6 months after challenge.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or non-pregnant female between 18 and 50 years of age, inclusive, at time of informed consent
. Willingness to participate after written informed consent obtained
. 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)
. 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.
. Demonstrated comprehension of the protocol procedures including knowledge of Campylobacter illness by passing a written examination (passing grade ≥ 70%).
. General good health, without significant medical illness or abnormal physical examination findings as determined by the PI.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Solicited or Unsolicited Adverse Events
. Laboratory values are Grade 1 or lower using the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 as defined below:
. Absolute neutrophil count ≥ 1500/μL
Exclusion criteria
. Significant medical condition or laboratory abnormalities that in the opinion of the Principal Investigator preclude participation in the study.
. History of Covid symptoms or positive Covid test within 2 weeks prior to admission date.
. Alcohol or illicit drug abuse/dependency
. Positive serology results for HIV, HBsAg, or HCV with confirmatory assays.
. Pregnancy or breastfeeding
. 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.
. Evidence of neurological abnormalities.
. History of reactive arthritis or evidence of inflammatory arthritis on exam.