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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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).

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04835792
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	FlightPath Biosciences, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Lyme Disease

Arms & Interventions

Arms

: Previously Treated for Lyme Disease

: Healthy Volunteers

Interventions

Other: - Stool and blood collection

One-time stool and blood collection

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Dr. Curtis Scribner, Berkeley, California

Status

Recruiting

Address

Dr. Curtis Scribner

Berkeley, California, 94710

Site Contact

Matt Tindall

[email protected]

415-530-1828

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