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

• Sponsor: FlightPath Biosciences, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04835792
• Collaborator: (none)
• Enrollment: 1,000
• Location: 1
• Anticipated Duration (Months): 6.3
• Patients Per Site Per Month: 157.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Lyme Disease	Other: Stool and blood collection

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Biomarker Study to Evaluate Participants With Previously Treated Lyme Disease in Comparison to Healthy Volunteers
• Actual Study Start Date: Mar 21, 2021
• Anticipated Primary Completion Date: Sep 30, 2021
• Anticipated Study Completion Date: Sep 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. • To evaluate and compare the microbiome of normal participants and participants with previously treated Lyme Disease [30 days]

2. • To evaluate and compare the transcriptome of normal participants and participants with previously treated Lyme Disease [30 days]

3. • To evaluate and compare the metabolome of normal participants and participants with previously treated Lyme Disease [30 days]

4. • Evaluation of symptoms and prior medications/treatments of normal participants and participants with previously treated Lyme Disease [30 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dr. Curtis Scribner	Berkeley	California	United States	94710

Sponsors and Collaborators

• FlightPath Biosciences, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: FlightPath Biosciences, Inc.
• ClinicalTrials.gov Identifier: NCT04835792
• Other Study ID Numbers: FP-LD-001
• First Posted: Apr 8, 2021
• Last Update Posted: Apr 8, 2021
• Last Verified: Apr 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lyme Disease

Study Results

No Results Posted as of Apr 8, 2021