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

• Conditions: Lyme Disease
• Interventions: Other: Stool and blood collection

• Registration Number: NCT04835792
• Lead Sponsor: FlightPath Biosciences, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-21
• Status Verified: 2021-04
• Study First Submitted: 2021-04-06
• Study First Submitted QC: 2021-04-06
• Last Update Submitted: 2021-04-06
• Study First Posted: 2021-04-08
• Last Update Posted: 2021-04-08
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Previously Treated for Lyme Disease	Stool and blood collection	-
Healthy Volunteers	Stool and blood collection	-

Primary Outcome Measures

Name	Time	Method
• To evaluate and compare the metabolome of normal participants and participants with previously treated Lyme Disease	30 days
• To evaluate and compare the microbiome of normal participants and participants with previously treated Lyme Disease	30 days
• Evaluation of symptoms and prior medications/treatments of normal participants and participants with previously treated Lyme Disease	30 days
• To evaluate and compare the transcriptome of normal participants and participants with previously treated Lyme Disease	30 days

Trial Locations

Locations (1)

Dr. Curtis Scribner; 🇺🇸 Berkeley, California, United States