Biomarker Study of Previously Treated Lyme Disease Volunteers in Comparison to Healthy Volunteers

Status unconfirmed

Conditions studied: Lyme Disease

In brief

Non-interventional study evaluating stool and blood samples collected from individuals previously treated with Lyme disease versus healthy volunteers

Key facts

Study ID

NCT04835792

Run by

FlightPath Biosciences, Inc.

People needed

1000

Starts

2021-03-21

Expected to finish

2021-09-30

Last updated by the study team

2021-04-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• Unwilling or unable to comply with the protocol (e.g., scheduled visits, laboratory tests, other study procedures, and study restrictions).

Where it is running

• Dr. Curtis Scribner — Berkeley, California, United States (enrolling)

Full record on ClinicalTrials.gov

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