Investigating Health Impacts of Exposure to Harmful Algal Blooms

NCT06883227 | Recruiting

• 1 other identifier: RI-ET-001
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Red Tide; Neurologic Disorder; Florida

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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).

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

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).

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Roskamp Institute Inc.: lead

Study Sites (1)

The Roskamp Institute

Sarasota, Florida, 34232, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample

MeSH Terms

Conditions

Nervous System Diseases; Mental Fatigue; Cough

Condition Hierarchy (Ancestors)

Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory

Study Officials

• Laila Abdullah Principal Investigator, Ph.D

  The Roskamp Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dakota Helgager Clinical Research Site Coordinator, Bachelor's

CONTACT

9412568010; redtide@roskampclinic.org

Ayse Cemek Clinical Research Coordinator, Bachelors

CONTACT

9412568010; redtide@roskampclinic.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 19, 2025
• Study Start: October 14, 2024
• Primary Completion (Estimated): October 14, 2029
• Study Completion (Estimated): October 14, 2030
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)