- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06579170
Burden of Recreational Water Illness Due to Exposure to Cyanobacteria and Their Toxins in Freshwater Beaches in Canada
September 2, 2025 updated by: Ian Young, Toronto Metropolitan University
Burden of Recreational Water Illness Due to Exposure to Cyanobacteria and Their Toxins in Freshwater Beaches in Canada: a Prospective Cohort Study
Swimming and other recreational water activities at public beaches are increasingly popular leisure activities among Canadians.
However, harmful algal blooms caused by blue-green algae (i.e., cyanobacteria) have also been increasing reported at Canadian public beaches in recent years.
These algal blooms can cause various acute illnesses among recreational water users through ingestion, inhalation of aerosols, or skin contact with contaminated water.
In addition, blue-green algae blooms and their toxins can cause illnesses in pets and wildlife.
Currently, baseline data are lacking on the risk of recreational water illness from exposure to blue-green algae blooms in Canada.
This study will identify the burden of recreational water illness among recreational water users at four targeted beach sites in Ontario, Manitoba and Nova Scotia, over a two-year period.
A prospective cohort study design will be used.
The investigators will determine the risk of acquiring acute illness outcomes in recreational water users, as well as their pet dogs, that engage in different levels of water contact at beaches at risk of blue-green algae blooms.
The investigators will examine differences in illness risks by gender, age, and location.
Relationships between cyanobacterial cell counts, toxin levels, and environmental conditions with the risk of acute illness among participants will be determined.
Overall, results will provide important data on the risk of recreational water illness from exposure to blue-green algae and their toxins in Canadian beach settings.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
This study will investigate the incidence of recreational water illness due to exposure to cyanobacterial blooms and their toxins in four targeted and popular freshwater beaches in Ontario, Manitoba, and Nova Scotia, Canada.
A prospective cohort design and One Health approach will be used.
On-site recruitment of recreational water users will be conducted at two beaches per year during the summers of 2024 and 2025.
The population of interest includes recreational water users of any age and their pet dogs.
After enrollment, an in-person survey will determine beach exposures and confounding factors, and a three-day follow-up survey will ascertain any acute illness outcomes experienced by participants or their dogs.
The target sample size is 2500 recreational water users.
Water samples will be taken each recruitment day and analyzed for cyanobacterial indicators (pigments), cell counts, and toxin levels.
Regression analysis will be conducted to estimate the association with water contact, cyanobacterial levels, and risks of different acute illness outcomes.
Study Type
Observational
Enrollment (Estimated)
2500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R0E 0T0
- Grand Beach
-
-
Nova Scotia
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Halifax, Nova Scotia, Canada, B2X 2W5
- Shubenacadie Canal
-
-
Ontario
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Port Perry, Ontario, Canada, L9L 1R2
- Kinsmen beach
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Windsor, Ontario, Canada, N0R 1G0
- Colchester Beach
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Recreational water users of any age, and any pet dogs also present at the beaches/waterfront areas, during the study recruitment days.
Description
Inclusion Criteria:
- ability to provide informed consent
- ability to complete the surveys in English or French
- must not have participated in the study in the past 21 days
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Recreational water users
Recreational water users of any age and their pet dogs present at the beaches and waterfronts in this study during recruitment days.
|
Cyanobacteria levels in beach water among participants who report water contact in the beach survey
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of gastrointestinal illness among participants
Time Frame: Within 3 days of beach visit
|
Gastrointestinal illness is defined as one or more of: (a) diarrhea (≥3 loose stools in 24 hrs); (b) vomiting; (c) nausea with stomach cramps; or (d) nausea or stomach cramps that interfere with regular daily activities (e.g., missed work or school)
|
Within 3 days of beach visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of respiratory illness among participants
Time Frame: Within 3 days of beach visit
|
Defined as: sore throat, runny or congested nose, difficulty breathing, or cough
|
Within 3 days of beach visit
|
|
Incidence of eye infections among participants
Time Frame: Within 3 days of beach visit
|
Defined as: eye infection or irritation
|
Within 3 days of beach visit
|
|
Incidence of skin infections among participants
Time Frame: Within 3 days of beach visit
|
Defined as: rash or itchy skin
|
Within 3 days of beach visit
|
|
Incidence of generalized symptoms among participants
Time Frame: Within 3 days of beach visit
|
Defined as: headache, fever, fatigue, dizziness, loss of appetite, chills, muscle pain, or general pain
|
Within 3 days of beach visit
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of illness severity measures among participants
Time Frame: Within 3 days of beach visit
|
Medical consultations, hospital visits, medication use, and hospitalization
|
Within 3 days of beach visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2024
Primary Completion (Estimated)
September 15, 2025
Study Completion (Estimated)
March 31, 2026
Study Registration Dates
First Submitted
August 28, 2024
First Submitted That Met QC Criteria
August 28, 2024
First Posted (Actual)
August 30, 2024
Study Record Updates
Last Update Posted (Estimated)
September 9, 2025
Last Update Submitted That Met QC Criteria
September 2, 2025
Last Verified
September 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2324-HQ-000024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
An anonymized dataset will be shared publicly after results are published.
IPD Sharing Time Frame
Study protocol is already published.
Code and dataset will be shared after study publication of results.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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