Lyme DiseaseNCT04835792
Biomarker Study of Previously Treated Lyme Disease Volunteers in Comparison to Healthy Volunteers
An observational study of Lyme Disease, run by FlightPath Biosciences, Inc. at 1 site in United States.
Trial summary
Non-interventional study evaluating stool and blood samples collected from individuals previously treated with Lyme disease versus healthy volunteers Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lyme Disease
- What is being tested?
- Stool and blood collection
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2021to 30 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Previously treated Lyme disease volunteers and healthy volunteers
Who may be able to join
- Males and females ≥18 years of age.
- Able to read, understand, and provide signed informed consent.
- Willing to provide blood and stool samples.
- Able to communicate adequately and to comply with the requirements for the entire study.
- Must be willing to discontinue antibiotics 2 weeks prior to sample collection.
- 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).
- 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
Who cannot join
- 1. Unwilling or unable to comply with the protocol (e.g., scheduled visits, laboratory tests, other study procedures, and study restrictions).
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Dr. Curtis Scribner
Berkeley, California, 94710
Matt Tindall, 415-530-1828, matt@flightpath.bio
About this study
Official title: 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
- Conditions
- Lyme Disease
- Being tested
- Stool and blood collection
- Medical subject headings
- Lyme Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool and blood collectionOther
One-time stool and blood collection
| Study group | Role | What they receive |
|---|---|---|
| Previously Treated for Lyme Disease | Not described Receives: Other: Stool and blood collection | |
| Healthy Volunteers | Not described Receives: Other: Stool and blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
• To evaluate and compare the microbiome of normal participants and participants with previously treated Lyme Disease
Measured: 30 days
• To evaluate and compare the transcriptome of normal participants and participants with previously treated Lyme Disease
Measured: 30 days
• To evaluate and compare the metabolome of normal participants and participants with previously treated Lyme Disease
Measured: 30 days
• Evaluation of symptoms and prior medications/treatments of normal participants and participants with previously treated Lyme Disease
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start21 Mar 2021
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lyme DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FlightPath Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835792
- Sponsor's protocol ID
- FP-LD-001
- Status last verified
- Apr 2021
- First submitted
- 6 Apr 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker Study to Evaluate Participants With Previously Treated Lyme Disease in Comparison to Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04835792
- Acronym / sponsor ID
- FP-LD-001
- Conditions
- Lyme Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- FlightPath Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 Mar 2021 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Non-interventional study evaluating stool and blood samples collected from individuals previously treated with Lyme disease versus healthy volunteers
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Previously Treated for Lyme Disease | – | Other: Stool and blood collection |
| Healthy Volunteers | – | Other: Stool and blood collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Previously treated Lyme disease volunteers and healthy volunteers
Key inclusion criteria (7 listed)
- Males and females ≥18 years of age.
- Able to read, understand, and provide signed informed consent.
- Willing to provide blood and stool samples.
- Able to communicate adequately and to comply with the requirements for the entire study.
- Must be willing to discontinue antibiotics 2 weeks prior to sample collection.
Key exclusion criteria (1 listed)
- 1. Unwilling or unable to comply with the protocol (e.g., scheduled visits, laboratory tests, other study procedures, and study restrictions).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stool and blood collectionOne-time stool and blood collection | Other | Healthy Volunteers, Previously Treated for Lyme Disease |
Primary outcome
• 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lyme Disease, run by FlightPath Biosciences, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matt Tindall (415-530-1828, matt@flightpath.bio), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• To evaluate and compare the microbiome of normal participants and participants with previously treated Lyme Disease (time frame: 30 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.