Cyanobacteria Allergy in Lake Kineret

Itching Clinical Trial

Official title:

Cyanobacteria Allergy in Lake Kineret

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01693198
• Other study ID #: 0172-12-MMC
• Status: Not yet recruiting
• Phase: N/A
• First received: September 19, 2012
• Last updated: September 23, 2012
• Start date: November 2012
• Est. completion date: November 2014

Study information

• Verified date: September 2012
• Source: Meir Medical Center
• Contact: Ronit Confino-Cohen, MD
• Phone: 97297472811
• Email: ronitco[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel : Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age above 18

• exposed to Lake Keneret water by swiming or sirfing

Exclusion Criteria:

• age under 18

• pregnancy

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Itching
• Nasal Stuffiness
• Sneezing

Intervention

Procedure:
• Skin test with sterile extracts of different cyanobacteria
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 .

Locations

Country	Name	City	State
Israel	Meir medical center	Kfar-Saba

Sponsors (2)

Lead Sponsor	Collaborator
Meir Medical Center	Yigal Allon Kinneret Limnological Laboratory

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reproducibility of skin test to cyanobacteria		Immediately after performing the test (15 minutes)	No