<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01693198</url>
  </required_header>
  <id_info>
    <org_study_id>0172-12-MMC</org_study_id>
    <nct_id>NCT01693198</nct_id>
  </id_info>
  <brief_title>Cyanobacteria Allergy in Lake Kineret</brief_title>
  <official_title>Cyanobacteria Allergy in Lake Kineret</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meir Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Yigal Allon Kinneret Limnological Laboratory</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Meir Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      People swimming or surfing in lake Kineret , sometimes complain of nasal stuffiness ,&#xD;
      sneezing and itching .Typically, it happens during or immediately after contact with the&#xD;
      lake's water . The symptoms are compatible with immediate allergic reaction. Previous reports&#xD;
      suggested a connection between similar symptoms and contact with different cyanobacteria&#xD;
      (living in fresh water lakes). In this study we intend to prove the mechanism of these&#xD;
      reactions. To prove the exact allergen that causes allergic rhinitis allergists perform skin&#xD;
      tests with different suspected allergens. Likewise, we would like to perform skin tests to&#xD;
      different proteins extracted from cyanobacteria collected in lake Kineret.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2012</start_date>
  <completion_date type="Anticipated">November 2014</completion_date>
  <primary_completion_date type="Anticipated">November 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reproducibility of skin test to cyanobacteria</measure>
    <time_frame>Immediately after performing the test (15 minutes)</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Nasal Stuffiness</condition>
  <condition>Sneezing</condition>
  <condition>Itching</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Skin test with sterile extracts of different cyanobacteria</intervention_name>
    <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 .</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age above 18&#xD;
&#xD;
          -  exposed to Lake Keneret water by swiming or sirfing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age under 18&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Ronit Confino-Cohen, MD</last_name>
    <phone>97297472811</phone>
    <email>ronitco@clalit.org.il</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Arnon Goldberg, MD</last_name>
    <phone>97297472717</phone>
    <email>arnong@clalit.org.il</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Meir medical center</name>
      <address>
        <city>Kfar-Saba</city>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Ronit Confino-Cohen, MD</last_name>
      <email>ronitco@clalit.org.il</email>
    </contact>
    <contact_backup>
      <last_name>Arnon Goldberg, MD</last_name>
      <email>arnong@clalit.org.il</email>
    </contact_backup>
    <investigator>
      <last_name>Ronit Confino-Cohen, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Arnon Goldberg, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <reference>
    <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. &amp; 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. &amp; 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. &amp; 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. &amp; Weiszfeiler, V. Interlaboratory comparison trial on cylindrospermopsin measurement. Analytical Biochemistry 2004; 332, 280-284. 9.Lawton, L.A., Edwards, C. &amp; 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</citation>
  </reference>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>September 23, 2012</last_update_submitted>
  <last_update_submitted_qc>September 23, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 26, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Meir Medical Center</investigator_affiliation>
    <investigator_full_name>Ronit Confino-Cohen</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>allergy</keyword>
  <keyword>cyanobacteria</keyword>
  <keyword>sweet water swimming</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypersensitivity</mesh_term>
    <mesh_term>Sneezing</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01693198
org study id: 0172-12-MMC
nct id: NCT01693198
lead sponsor: 
collaborator: 
has dmc: Yes
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Reproducibility of skin test to cyanobacteria
time frame: Immediately after performing the test (15 minutes)
intervention type: Procedure
intervention name: Skin test with sterile extracts of different cyanobacteria
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 .
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ronit Confino-Cohen, MD
phone: 97297472811
email: ronitco@clalit.org.il
last name: Arnon Goldberg, MD
phone: 97297472717
email: arnong@clalit.org.il
facility: 
contact: 
contact backup: 
investigator: 
investigator: 
country: Israel
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
responsible party type: Principal Investigator
investigator affiliation: Meir Medical Center
investigator full name: Ronit Confino-Cohen
investigator title: MD
mesh term: Hypersensitivity
mesh term: Sneezing