Cyanobacteria Allergy in Lake Kineret
Primary Purpose
Nasal Stuffiness, Sneezing, Itching
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Skin test with sterile extracts of different cyanobacteria
Sponsored by
About this trial
This is an interventional diagnostic trial for Nasal Stuffiness focused on measuring allergy, cyanobacteria, sweet water swimming
Eligibility Criteria
Inclusion Criteria:
- age above 18
- exposed to Lake Keneret water by swiming or sirfing
Exclusion Criteria:
- age under 18
- pregnancy
Sites / Locations
- Meir medical center
Outcomes
Primary Outcome Measures
Reproducibility of skin test to cyanobacteria
Secondary Outcome Measures
Full Information
NCT ID
NCT01693198
First Posted
September 19, 2012
Last Updated
September 23, 2012
Sponsor
Meir Medical Center
Collaborators
Yigal Allon Kinneret Limnological Laboratory
1. Study Identification
Unique Protocol Identification Number
NCT01693198
Brief Title
Cyanobacteria Allergy in Lake Kineret
Official Title
Cyanobacteria Allergy in Lake Kineret
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2014 (Anticipated)
Study Completion Date
November 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Meir Medical Center
Collaborators
Yigal Allon Kinneret Limnological Laboratory
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Stuffiness, Sneezing, Itching
Keywords
allergy, cyanobacteria, sweet water swimming
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Skin test with sterile extracts of different cyanobacteria
Intervention Description
Skin test with sterile extracts of different cyanobacteria is performed on the volar aspect of the forearm. Typically, the results are read 15 minutes after performing the test. Test is regarded as positive when wheal of more than 3mm and flare appear within this time frame. Positive test indicates the existence of specific IgE to the extract in on skin mast cells .
Primary Outcome Measure Information:
Title
Reproducibility of skin test to cyanobacteria
Time Frame
Immediately after performing the test (15 minutes)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age above 18
exposed to Lake Keneret water by swiming or sirfing
Exclusion Criteria:
age under 18
pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ronit Confino-Cohen, MD
Phone
97297472811
Email
ronitco@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Arnon Goldberg, MD
Phone
97297472717
Email
arnong@clalit.org.il
Facility Information:
Facility Name
Meir medical center
City
Kfar-Saba
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronit Confino-Cohen, MD
Email
ronitco@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Arnon Goldberg, MD
Email
arnong@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Ronit Confino-Cohen, MD
First Name & Middle Initial & Last Name & Degree
Arnon Goldberg, MD
12. IPD Sharing Statement
Citations:
Citation
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
Results Reference
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Cyanobacteria Allergy in Lake Kineret
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