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Cyanobacteria Allergy in Lake Kineret

This study is not yet open for participant recruitment.
Verified September 2012 by Meir Medical Center
Sponsor:
Collaborator:
Yigal Allon Kinneret Limnological Laboratory
Information provided by (Responsible Party):
Ronit Confino-Cohen, Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01693198
First received: September 19, 2012
Last updated: September 23, 2012
Last verified: September 2012
History of Changes
  Purpose

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.


Condition Intervention
Nasal Stuffiness
Sneezing
Itching
 Procedure: Skin test with sterile extracts of different cyanobacteria

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Cyanobacteria Allergy in Lake Kineret

Resource links provided by NLM:

Drug Information available for: Anakinra
U.S. FDA Resources

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • Reproducibility of skin test to cyanobacteria [ Time Frame: Immediately after performing the test (15 minutes) ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: November 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    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 .
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age above 18
  • exposed to Lake Keneret water by swiming or sirfing

Exclusion Criteria:

  • age under 18
  • pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01693198

Contacts
Contact: Ronit Confino-Cohen, MD 97297472811 ronitco@clalit.org.il
Contact: Arnon Goldberg, MD 97297472717 arnong@clalit.org.il

Locations
Israel
Meir medical center Not yet recruiting
Kfar-Saba, Israel
Contact: Ronit Confino-Cohen, MD         ronitco@clalit.org.il    
Contact: Arnon Goldberg, MD         arnong@clalit.org.il    
Principal Investigator: Ronit Confino-Cohen, MD            
Sub-Investigator: Arnon Goldberg, MD            
Sponsors and Collaborators
Meir Medical Center
Yigal Allon Kinneret Limnological Laboratory
  More Information

No publications provided

Responsible Party: Ronit Confino-Cohen, MD, Meir Medical Center
ClinicalTrials.gov Identifier: NCT01693198     History of Changes
Other Study ID Numbers: 0172-12-MMC
Study First Received: September 19, 2012
Last Updated: September 23, 2012
Health Authority: Israel : Institutional Review Board

Keywords provided by Meir Medical Center:
allergy
cyanobacteria
sweet water swimming

Additional relevant MeSH terms:
Sneezing
Signs and Symptoms, Respiratory
Signs and Symptoms
Interleukin 1 Receptor Antagonist Protein
 Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013