Lyme Disease
Conditions
Brief summary
Non-interventional study evaluating stool and blood samples collected from individuals previously treated with Lyme disease versus healthy volunteers
Interventions
One-time stool and blood collection
Sponsors
FlightPath Biosciences, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Males and females ≥18 years of age. 2. Able to read, understand, and provide signed informed consent. 3. Willing to provide blood and stool samples. 4. Able to communicate adequately and to comply with the requirements for the entire study. 5. Must be willing to discontinue antibiotics 2 weeks prior to sample collection. 6. If participating in the previously treated Lyme Disease arm, the participants must meet the following criteria: 1) Diagnosis of prior Lyme Disease supported by either an erythema migrans rash (either classic bull's eye or irregular) OR a CDC-positive Western blot, 2) previously treated with antibiotics for Lyme Disease, 3) remains ill six months or more after receiving preliminary treatment with antibiotics for Lyme disease (e.g., fatigue, musculoskeletal pain, or neurocognitive symptoms). 7. If participating in the healthy volunteer arm, the participants must meet the following criteria: 1) must not have had a Lyme Disease diagnosis, 2) in generally good health
Exclusion criteria
1\. Unwilling or unable to comply with the protocol (e.g., scheduled visits, laboratory tests, other study procedures, and study restrictions).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • To evaluate and compare the microbiome of normal participants and participants with previously treated Lyme Disease | 30 days |
| • To evaluate and compare the transcriptome of normal participants and participants with previously treated Lyme Disease | 30 days |
| • To evaluate and compare the metabolome of normal participants and participants with previously treated Lyme Disease | 30 days |
| • Evaluation of symptoms and prior medications/treatments of normal participants and participants with previously treated Lyme Disease | 30 days |
Countries
United States
Contacts
Primary ContactMatt Tindall
Outcome results
None listed