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

April 6, 2021 updated by: FlightPath Biosciences, Inc.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Berkeley, California, United States, 94710
        • Recruiting
        • Dr. Curtis Scribner
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Previously treated Lyme disease volunteers and healthy volunteers

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy Volunteers
Other: Stool and blood collection
One-time stool and blood collection
Previously Treated for Lyme Disease
Other: Stool and blood collection
One-time stool and blood collection

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FlightPath Biosciences, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 21, 2021

Primary Completion (ANTICIPATED)

September 30, 2021

Study Completion (ANTICIPATED)

September 30, 2021

Study Registration Dates

First Submitted

April 6, 2021

First Submitted That Met QC Criteria

April 6, 2021

First Posted (ACTUAL)

April 8, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 8, 2021

Last Update Submitted That Met QC Criteria

April 6, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FP-LD-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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