About this trial
The purpose of this study is to compare the frequency of symptoms, exposure and health impacts in persons living in areas where they are exposed to bloom and non-bloom periods of cyanobacteria and red tide in Florida.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
18 years or older
live, visit, and/ or work in the following Florida counties: Indian River, St. Lucie, Charlotte, Collier, Hendry, Hillsborough, Lee, Manatee, Martin, Monroe, Okeechobee, Palm Beach, Pasco, Pinellas, Indian River, and/or Sarasota
able to read and understand English
Disqualifiers
unable to independently consent
younger than 18 years old
prisoner
pregnant women
Trial population
The study population will include up to 400 individuals who are 18yrs of age or older, visit, live or work in specific Florida counties and who read and understand English and consent to participation.
Trial design
Case-control
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
To correlate self- reported symptom occurrence with recreational/occupational cyanotoxin exposure (measured in air and water environmental samples) and cyanotoxin levels in blood, nasal swab
These data will be linked to determine if and how much contact the participant may have had with Florida waters, presence of cyanotoxin in the bio samples (blood, nasal swabs, and urine) and self-reported health issues to determine the impact of harmful algal blooms (HABs) on human health. In addition, this study will explore a potential link between self-reported COVID-19 exposure/infection and susceptibility to cyanotoxins and establish a HAB biorepository.
Secondary outcomes
Continue the study of previously enrolled cohort participants prospectively to determine whether long-term effects can be attributed to exposure to microcystins and brevetoxins (Florida Red Tide).
Previously enrolled cohort participants will be screened, consented and enrolled, complete a questionnaire, self- collect nasal swab and urine sample and collection of blood.
Recruit and establish new study participants on the West Coast of Florida (coastal Lee County) to further study the health effects of exposure to Red Tide.
New participants will be screened, consented and enrolled, complete a questionnaire, self- collect nasal swab and urine sample and collection of blood.
Apply novel approaches to measure biomarkers in samples included in the biobank repository and maintained in the FAU Health Clinical Research Unit using using logistic regression and Generalized Linear Mixed Models (GLMM).
Access is granted through our continued relationship with FAU and Dr. McFarland as Co-PI. The concentrations of inflammatory biomarkers will be compared between 30 participants reporting dry cough, and/or wheezy respirations and 30 who reported neither of these symptoms and for whom serum samples are stored in the biobank. The data will be analyzed using parametric statistics with adjustment for potential confounders. Statistical analyses of the relationships between environmental concentrations of HAB toxins and concentrations in human tissues will be performed initially using standard regression techniques. Multivariable modelling of the relationships between environmental concentrations, tissue concentrations, symptom frequency and biomarkers will be conducted using logistic regression and Generalized Linear Mixed Models (GLMM) as appropriate for the data form.
Analysis of data collected during our previous studies in 2016, 2018, and 2020-2023 to explore risk factors that potentially increase the susceptibility to the respiratory impacts of harmful algal bloom toxin exposure.
Locations
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Sponsors and contacts
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University of Central Florida
Lead sponsor
Florida Atlantic University
Collaborator
Florida Department of Health
Collaborator