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Biomarker Study of Previously Treated Lyme Disease Volunteers in Comparison to Healthy Volunteers | Clinical Trials | Clareo Health

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

Biomarker Study to Evaluate Participants With Previously Treated Lyme Disease in Comparison to Healthy Volunteers

NCT04835792•FlightPath Biosciences, Inc.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - No limit years

Sex

ALL

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).

Locations (1)

Dr. Curtis Scribner

Berkeley, California, United States

Key Dates

Start Date

March 21, 2021

Primary Completion Date

September 30, 2021

Completion Date

September 30, 2021

Last Updated

April 8, 2021

Enrollment

1,000

ESTIMATED participants

Conditions

Lyme Disease

Interventions

Stool and blood collection

OTHER

Contacts

Matt Tindall

CONTACT

415-530-1828 matt@flightpath.bio

A Comprehensive Clinical, Microbiological and Immunological Assessment of Patients With Suspected Post Treatment Lyme Disease Syndrome and Selected Control Populations

NCT00001539

Lyme Disease

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RECRUITING

Rheumatology Patient Registry and Biorepository

NCT04402086

Rheumatic DiseasesAdult Onset Still Disease+18 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 8, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Comprehensive Clinical, Microbiological and Immunological Assessment of Patients With Suspected Post Treatment Lyme Disease Syndrome and Selected Control Populations

Rheumatology Patient Registry and Biorepository

Ceftriaxone for Post-Treatment Lyme Disease

Human Immune Response to Ixodes Scapularis Tick Bites

Borrelia B-cell Diagnostics

Effect of Auricular Vagal Nerve Electrical Stimulation on Post-Treatment Lyme Disease Syndrome