Status:
UNKNOWN
Biomarker Study of Previously Treated Lyme Disease Volunteers in Comparison to Healthy Volunteers
Lead Sponsor:
FlightPath Biosciences, Inc.
Conditions:
Lyme Disease
Eligibility:
All Genders
18+ years
Brief Summary
Non-interventional study evaluating stool and blood samples collected from individuals previously treated with Lyme disease versus healthy volunteers
Eligibility Criteria
Inclusion
- Males and females ≥18 years of age.
- Able to read, understand, and provide signed informed consent.
- Willing to provide blood and stool samples.
- Able to communicate adequately and to comply with the requirements for the entire study.
- Must be willing to discontinue antibiotics 2 weeks prior to sample collection.
- 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).
- 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
- 1\. Unwilling or unable to comply with the protocol (e.g., scheduled visits, laboratory tests, other study procedures, and study restrictions).
Key Trial Info
Start Date :
March 21 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2021
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04835792
Start Date
March 21 2021
End Date
September 30 2021
Last Update
April 8 2021
Active Locations (1)
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1
Dr. Curtis Scribner
Berkeley, California, United States, 94710