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

Lyme Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04835792
• Other study ID #: FP-LD-001
• Status: Recruiting
• Start date: March 21, 2021
• Est. completion date: September 30, 2021

Study information

• Verified date: April 2021
• Source: FlightPath Biosciences, Inc.
• Contact: Matt Tindall
• Phone: 415-530-1828
• Email: matt[@]flightpath.bio
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Lyme Disease

Intervention

Other:
• Stool and blood collection
One-time stool and blood collection

Locations

Country	Name	City	State
United States	Dr. Curtis Scribner	Berkeley	California

Sponsors (1)

Lead Sponsor	Collaborator
FlightPath Biosciences, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• To evaluate and compare the microbiome of normal participants and participants with previously treated Lyme Disease		30 days
Primary	• To evaluate and compare the transcriptome of normal participants and participants with previously treated Lyme Disease		30 days
Primary	• To evaluate and compare the metabolome of normal participants and participants with previously treated Lyme Disease		30 days
Primary	• Evaluation of symptoms and prior medications/treatments of normal participants and participants with previously treated Lyme Disease		30 days