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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-21

Study Completion Date

2021-09-30

Brief Summary

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

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Detailed Description

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Conditions

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Lyme Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Previously Treated for Lyme Disease

Stool and blood collection

Intervention Type OTHER

One-time stool and blood collection

Healthy Volunteers

Stool and blood collection

Intervention Type OTHER

One-time stool and blood collection

Interventions

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Stool and blood collection

One-time stool and blood collection

Intervention Type OTHER

Eligibility Criteria

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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