Ignite Creation Date:
2025-12-24 @ 3:38 PM
Ignite Modification Date:
2026-01-02 @ 10:10 AM
Study NCT ID:
NCT04835792
Status:
UNKNOWN
Last Update Posted:
2021-04-08
First Post:
2021-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Biomarker Study of Previously Treated Lyme Disease Volunteers in Comparison to Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008193', 'term': 'Lyme Disease'}], 'ancestors': [{'id': 'D016905', 'term': 'Gram-Negative Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001899', 'term': 'Borrelia Infections'}, {'id': 'D013145', 'term': 'Spirochaetales Infections'}, {'id': 'D017282', 'term': 'Tick-Borne Diseases'}, {'id': 'D000079426', 'term': 'Vector Borne Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003672', 'term': 'Defecation'}], 'ancestors': [{'id': 'D004068', 'term': 'Digestive System Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-06', 'studyFirstSubmitDate': '2021-04-06', 'studyFirstSubmitQcDate': '2021-04-06', 'lastUpdatePostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '• To evaluate and compare the microbiome of normal participants and participants with previously treated Lyme Disease', 'timeFrame': '30 days'}, {'measure': '• To evaluate and compare the transcriptome of normal participants and participants with previously treated Lyme Disease', 'timeFrame': '30 days'}, {'measure': '• To evaluate and compare the metabolome of normal participants and participants with previously treated Lyme Disease', 'timeFrame': '30 days'}, {'measure': '• Evaluation of symptoms and prior medications/treatments of normal participants and participants with previously treated Lyme Disease', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lyme Disease']}, 'descriptionModule': {'briefSummary': 'Non-interventional study evaluating stool and blood samples collected from individuals previously treated with Lyme disease versus healthy volunteers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Previously treated Lyme disease volunteers and healthy volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males and females ≥18 years of age.\n2. Able to read, understand, and provide signed informed consent.\n3. Willing to provide blood and stool samples.\n4. Able to communicate adequately and to comply with the requirements for the entire study.\n5. Must be willing to discontinue antibiotics 2 weeks prior to sample collection.\n6. 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).\n7. 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\n\nExclusion Criteria:\n\n1\\. Unwilling or unable to comply with the protocol (e.g., scheduled visits, laboratory tests, other study procedures, and study restrictions).'}, 'identificationModule': {'nctId': 'NCT04835792', 'briefTitle': 'Biomarker Study of Previously Treated Lyme Disease Volunteers in Comparison to Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'FlightPath Biosciences, Inc.'}, 'officialTitle': 'Biomarker Study to Evaluate Participants With Previously Treated Lyme Disease in Comparison to Healthy Volunteers', 'orgStudyIdInfo': {'id': 'FP-LD-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Previously Treated for Lyme Disease', 'interventionNames': ['Other: Stool and blood collection']}, {'label': 'Healthy Volunteers', 'interventionNames': ['Other: Stool and blood collection']}], 'interventions': [{'name': 'Stool and blood collection', 'type': 'OTHER', 'description': 'One-time stool and blood collection', 'armGroupLabels': ['Healthy Volunteers', 'Previously Treated for Lyme Disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94710', 'city': 'Berkeley', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Matt Tindall', 'role': 'CONTACT', 'email': 'matt@flightpath.bio', 'phone': '415-530-1828'}], 'facility': 'Dr. Curtis Scribner', 'geoPoint': {'lat': 37.87159, 'lon': -122.27275}}], 'centralContacts': [{'name': 'Matt Tindall', 'role': 'CONTACT', 'email': 'matt@flightpath.bio', 'phone': '415-530-1828'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'FlightPath Biosciences, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}