Red TideNCT06883227
Investigating Health Impacts of Exposure to Harmful Algal Blooms
An observational study of Red Tide and Neurologic Disorder, run by Roskamp Institute Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Red Tide, Neurologic Disorder, Florida
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2024to 14 Oct 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dakota Helgager Clinical Research Site Coordinator, Bachelor's contact
United States1 site, 1 recruiting
- Recruiting
The Roskamp Institute
Sarasota, Florida, 34232
Dakota M Helgager, B.S, 9412568010, redtide@roskampclinic.org
Ayse Cemek, B.S, 9412568019 ext. 3041, acemek@roskampclinic.org
About this study
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.
Read the 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.
- Conditions
- Red Tide, Neurologic Disorder, Florida
- Keywords
- Brain fog, Red Tide, respiratory, coughing, neurotoxin, beach, florida
- Medical subject headings
- Nervous System Diseases, Mental Fatigue, Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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))
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start14 Oct 2024
- Primary completion14 Oct 2029 (estimated)
- Study completion14 Oct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Red TideStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roskamp Institute Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laila Abdullah Principal Investigator, Ph.D, Principal investigator, The Roskamp Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06883227
- Sponsor's protocol ID
- RI-ET-001
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2025
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Health Impacts of Exposure to Harmful Algal Blooms
- ClinicalTrials.gov ID
- NCT06883227
- Acronym / sponsor ID
- RI-ET-001
- Conditions
- Red Tide, Neurologic Disorder, Florida
- Keywords
- Brain fog, Red Tide, respiratory, coughing, neurotoxin, beach, florida
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Roskamp Institute Inc.University, hospital or other
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 14 Oct 2029 (estimated)
- Study completion
- 14 Oct 2030 (estimated)
- First posted
- 19 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: 4 years
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))
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Red Tide
RecruitingObservational study
Harmful Algal Blooms
Red Tide
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dakota Helgager Clinical Research Site Coordinator, Bachelor's contact
Laila Abdullah Principal Investigator, Ph.D principal investigator
The Roskamp Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Red Tide and Neurologic Disorder, run by Roskamp Institute Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dakota Helgager Clinical Research Site Coordinator, Bachelor's (9412568010, redtide@roskampclinic.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.