- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01693198
Cyanobacteria Allergy in Lake Kineret
September 23, 2012 updated by: Ronit Confino-Cohen, Meir Medical Center
People swimming or surfing in lake Kineret , sometimes complain of nasal stuffiness , sneezing and itching .Typically, it happens during or immediately after contact with the lake's water .
The symptoms are compatible with immediate allergic reaction.
Previous reports suggested a connection between similar symptoms and contact with different cyanobacteria (living in fresh water lakes).
In this study we intend to prove the mechanism of these reactions.
To prove the exact allergen that causes allergic rhinitis allergists perform skin tests with different suspected allergens.
Likewise, we would like to perform skin tests to different proteins extracted from cyanobacteria collected in lake Kineret.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ronit Confino-Cohen, MD
- Phone Number: 97297472811
- Email: ronitco@clalit.org.il
Study Contact Backup
- Name: Arnon Goldberg, MD
- Phone Number: 97297472717
- Email: arnong@clalit.org.il
Study Locations
-
-
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Kfar-Saba, Israel
- Meir Medical Center
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Contact:
- Ronit Confino-Cohen, MD
- Email: ronitco@clalit.org.il
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Contact:
- Arnon Goldberg, MD
- Email: arnong@clalit.org.il
-
Principal Investigator:
- Ronit Confino-Cohen, MD
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Sub-Investigator:
- Arnon Goldberg, MD
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age above 18
- exposed to Lake Keneret water by swiming or sirfing
Exclusion Criteria:
- age under 18
- pregnancy
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
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reproducibility of skin test to cyanobacteria
Time Frame: Immediately after performing the test (15 minutes)
|
Immediately after performing the test (15 minutes)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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.
General Publications
- 1. Carmichael W. A world overview-One-hundred-twentyseven years of research on toxic cyanobacteria-Where do we go from here? Adv Exp Med Biol 2008;619:105-125 2. Petrus M, Culerrier R, Campistron M, Barre A, Rouge P. First case report of anaphylaxis to spirulin: identification of phycocyanin as responsible allergen. AL L ERGY (AllergyNet) 2010; 65 : 924-932N 3. Torokne A, Palovics A, and Bankine M. Allergenic (sensitization, skin and eye Irritation).Effects of freshwater Cyanobacteria-experimental evidence. Environ Toxicol 2001; 16: 512-516 4.Alster, A., Kaplan-Levy, R., Sukenik, A. & Zohary, T. Morphology and phylogeny of a non-toxic invasive Cylindrospermopsis raciborskii from a Mediterranean Lake. Hydrobiologia 2010; 639, 115-128. 5.Banker, R., Carmeli, S., Hadas, O., Teltsch, B., Porat, R. & Sukenik, A. Identification of cylindrospermopsin in Aphanizomenon ovalisporum (Cyanophyceae) isolated from Lake Kinneret, Israel. Journal of Phycology 1997; 33, 613-616. 6.Hadas, O., Pinkas, R., Malinsky-Rushansky, N., Nishri, A., Kaplan, A., Rimmer, A. & Sukenik, A. Appearance and establishment of diazotrophic cyanobacteria in Lake Kinneret, Israel. Freshwater Biology 2012; 57, 1214-1227. 7. Bernstein JA, Ghosh D, Levin LS, Zheng S, Carmichael W, Lummus Z, Bernstein IL. Cyanobacteria: an unrecognized ubiquitous sensitizing allergen? Allergy Asthma Proc. 2011;32:106-110 8.Törökné, A., Asztalos, M., Bánkiné, M., Bickel, H., Borbély, G., Carmeli, S., Codd, G.A., Fastner, J., Huang, Q., Humpage, A., Metcalf, J.S., Rábai, E., Sukenik, A., Surányi, G., Vasas, G. & Weiszfeiler, V. Interlaboratory comparison trial on cylindrospermopsin measurement. Analytical Biochemistry 2004; 332, 280-284. 9.Lawton, L.A., Edwards, C. & Codd, G.A. Extraction and high-performance liquid chromatographic method for the determination of microcystins in raw and treated waters. Analyst 1994; 119, 1525-1530
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
November 1, 2012
Primary Completion (Anticipated)
November 1, 2014
Study Completion (Anticipated)
November 1, 2014
Study Registration Dates
First Submitted
September 19, 2012
First Submitted That Met QC Criteria
September 23, 2012
First Posted (Estimate)
September 26, 2012
Study Record Updates
Last Update Posted (Estimate)
September 26, 2012
Last Update Submitted That Met QC Criteria
September 23, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0172-12-MMC
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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