Investigating Health Impacts of Exposure to Harmful Algal Blooms

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.

Study Overview

• Status: Recruiting
• Conditions: Neurologic Disorder; Red Tide; Florida

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.

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

• Study Contact: Name: Dakota Helgager Clinical Research Site Coordinator, Bachelor's; Phone Number: 9412568010; Email: redtide@roskampclinic.org
• Study Contact Backup: Name: Ayse Cemek Clinical Research Coordinator, Bachelors; Phone Number: 9412568010; Email: redtide@roskampclinic.org

Study Locations

• United States
  • Florida
    • Sarasota, Florida, United States, 34232
      • Recruiting
      • The Roskamp Institute
      • Contact: Laila Abdullah, Ph.D
      • Contact: Dakota M Helgager, B.S; Phone Number: 9412568010; Email: redtide@roskampclinic.org
      • Contact: Ayse Cemek, B.S; Phone Number: 3041 9412568019; Email: acemek@roskampclinic.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

People who have been likely exposed to marine toxins (based on the areas that they frequent) as well as individuals who are unlikely to have been exposed will be recruited. Also, residents (temporary or permanent) of one of the following five southwest Florida counties (Lee, Collier, Charlotte, Sarasota, or Manatee).

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Main Study; All subjects will be asked to complete four in-person visits where the goal is for two visits to take place during the K. brevis bloom period and the other two visits will be when there is no K. brevis bloom ("not present" range according to the FWC K. brevis cell counts).
Sub-Study; Sponsor will enroll 45 randomly selected participants from the main cohort of participants who met the inclusion/exclusion criteria and agreed to take part in the PK sub-study. The only additional exclusion criteria will be pregnancy at the time of PK study. Participants will be asked to take part in the sub-study after their first visit where there was no bloom present. Participants in the relevant locations (areas in which there is red tide bloom present) will be contacted to initiate the PK studies, and data from their prior visit (when there was no red tide bloom present) will represent their baseline data (D0).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The 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))	4 years

Collaborators and Investigators

• Sponsor: Roskamp Institute Inc.
• Investigators: Principal Investigator: Laila Abdullah Principal Investigator, Ph.D, The Roskamp Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 14, 2024
• Primary Completion (Estimated): October 14, 2029
• Study Completion (Estimated): October 14, 2030

Study Registration Dates

• First Submitted: March 12, 2025
• First Submitted That Met QC Criteria: March 12, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 19, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: respiratory; Brain fog; coughing; Red Tide; neurotoxin; beach; florida
• Additional Relevant MeSH Terms: Nervous System Diseases
• Other Study ID Numbers: RI-ET-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No