Recruiting

Observational Study

Sponsor:

FlightPath Biosciences, Inc.

Code:

NCT04835792

Conditions

Lyme Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Stool and blood collection

Study Details

Brief summary:

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

Conditions

Lyme Disease

Study ID

NCT04835792

Start date

Mar 21, 2021

Status verified date

Apr, 2021

Completion date

Sep 30, 2021

Anticipated

Primary completion date

Sep 30, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Previously Treated for Lyme Disease

Healthy Volunteers

Interventions

Stool and blood collection

One-time stool and blood collection

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Dr. Curtis Scribner

Recruiting

Berkeley, California, United States, 94710

Contacts

More Information

Sponsor

FlightPath Biosciences, Inc.

Last update posted

Apr 8, 2021

Last verified

Apr, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by FlightPath Biosciences, Inc. on 2021-04-08.