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Investigating Health Impacts of Exposure to Harmful Algal Blooms

Investigating Health Impacts of Exposure to Harmful Algal Blooms

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06883227
Enrollment
400
Registered
2025-03-19
Start date
2024-10-14
Completion date
2030-10-14
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Florida, Neurologic Disorder, Red Tide

Keywords

Brain fog, Red Tide, respiratory, coughing, neurotoxin, beach, florida

Brief summary

The goals of this project are to study the biological effects of environmental toxins (ET), in particular aquatic toxins such as brevetoxins (PbTx) and microcystin or their metabolites. This study is designed to examine the effects of the body from harmful algae blooms (HAB) as well as possibility of an association between exposure to the marine toxin, brevetoxin (PbTx), which is released from K. brevis during the red tide bloom, and the prevalence of neurological illnesses.

Detailed description

Exposure to environmental toxins present in local waters, such as brevetoxins released by Karenia brevis (K. brevis) or microcystin produced by cyanobacteria, is known to cause skin and eye irritation, gastrointestinal and respiratory distress. The ingestion of high levels of brevetoxins from eating contaminated shellfish can result in Neurotoxic Shellfish Poisoning (NSP), an acute gastroenteritis with accompanying neurologic symptoms. People are often exposed by direct skin contact with contaminated waters, drinking contaminated water, breathing in airborne droplets of the toxins, or eating contaminated shellfish. This condition usually resolves itself within 3 days as the brevetoxins are excreted from the body. Aerosolized brevetoxins are also known to cause a reversible upper respiratory syndrome, characterized by coughing, sneezing, and feelings of irritation to the airways. Once the exposure to the brevetoxin-laden air has ceased, symptoms usually go away within 15 minutes. The main objective of this study is to determine if exposure to marine or similar environmental toxins can adversely affect CNS health, immune system, respiratory system and other biological processes which contribute to long-term cognitive dysfunction or illnesses in individuals exposed to these toxins. Sponsor will be examining whether general health signs and symptoms that are reported are as associated with the exposure to harmful algal bloom toxins. Known symptoms of exposure to harmful algae bloom/red tide /shellfish include the following: Skin and eye irritation, gastrointestinal and respiratory distress, acute gastroenteritis with accompanying neurologic symptoms, respiratory distress, such as reversible upper respiratory syndrome with symptoms of coughing, sneezing, and feelings of irritation to the airways.

Interventions

None listed

Sponsors

Roskamp Institute Inc.
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. Subject should be able to provide written informed consent. 2. Adult aged 18 or older. 3. Resident (temporary or permanent) of one of the following five southwest Florida counties (Lee, Collier, Charlotte, Sarasota, or Manatee). 4. Any race or ethnicity. 5. Willing to return for at least a total of four study visits and participate in all required procedures for the duration of the study.

Exclusion criteria

1. Inability to speak or write in English. 2. Any medical condition for which the study investigator believes enrollment is medically inappropriate. 3. Unwilling/unable to provide biological samples or poor venous access.

Design outcomes

Primary

MeasureTime frameDescription
Examination of marine or similar environmental toxins short-term and long-term adverse effects on central nervous system (CNS) health, immune system, respiratory health and other biological effects induced by aquatic environmental or related toxins.4 yearsThe Investigators want to examine the effects of the body from harmful algae blooms (HAB) as well as possibility of an association between exposure to the marine toxin, brevetoxin (PbTx), which is released from K. brevis during the red tide bloom, and the prevalence of neurological illnesses. Height and weight will be combined to assess BMI (BMI = weight (lb) ÷ height2 (inches))

Countries

United States

Contacts

Primary ContactDakota Helgager Clinical Research Site Coordinator, Bachelor's
redtide@roskampclinic.org9412568010
Backup ContactAyse Cemek Clinical Research Coordinator, Bachelors
redtide@roskampclinic.org9412568010

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026