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

NCT04835792 | Unknown

• 1 other identifier: FP-LD-001
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lyme Disease

Outcome Measures

Primary Outcomes (4)

• • To evaluate and compare the microbiome of normal participants and participants with previously treated Lyme Disease

  30 days

• • To evaluate and compare the transcriptome of normal participants and participants with previously treated Lyme Disease

  30 days

• • To evaluate and compare the metabolome of normal participants and participants with previously treated Lyme Disease

  30 days

• • Evaluation of symptoms and prior medications/treatments of normal participants and participants with previously treated Lyme Disease

  30 days

Study Arms (2)

Previously Treated for Lyme Disease

Other: Stool and blood collection

Healthy Volunteers

Other: Stool and blood collection

Interventions

Stool and blood collection OTHER

One-time stool and blood collection

Healthy Volunteers; Previously Treated for Lyme Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Previously treated Lyme disease volunteers and healthy volunteers

You may qualify if:

• 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

You may not qualify if:

• \. Unwilling or unable to comply with the protocol (e.g., scheduled visits, laboratory tests, other study procedures, and study restrictions).

Sponsors & Collaborators

• FlightPath Biosciences, Inc.: lead

Study Sites (1)

Dr. Curtis Scribner

Berkeley, California, 94710, United States

RECRUITING

MeSH Terms

Conditions

Lyme Disease

Interventions

Defecation

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Borrelia Infections; Spirochaetales Infections; Tick-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Digestive System Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Central Study Contacts

Matt Tindall

CONTACT

415-530-1828; matt@flightpath.bio

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 8, 2021
• Study Start: March 21, 2021
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-04

Locations

US (1)