The Effect of Radioactive Iodine Administration for Thyroid Diseases on H.Pylori Eradication

Sponsor
Rabin Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT00822289
Collaborator
(none)
120

Study Details

Study Description

Brief Summary

Because of the high iodine uptake in the stomach, radioactive iodine treatment for thyroid diseases (cancer or hyperthyroidism) or radioactive iodine administered for thyroid scan may be able to eradicate H.pylori infection from the stomach of patients infected with H.pylori.

Also to test the hypothesis that CagA virulent strains of H.pylori are more common in patients with thyroid cancer than with other thyroid diseases.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Objective To test eradicate H.pylori after administration of radioactive iodine (131I) to patients with thyroid diseases and to evaluate their H.pylori CagA status .

    Design Observational study

    Setting

    The Isotopic Institute at the Rabin Medical Center, Campus Beilinson Patients Consecutive patients with thyroid diseases referred to the Isotopic Institute at the Rabin Medical Center, Campus Beilinson for either radioactive iodine (131I) thyroid scan or radioactive iodine (131I)treatment for their disease, will be screened, prior to the radioactive iodine, for H. pylori infection and CagA protein by serology. Patient with positive serology for H. pylori will be tested for active gastric infection using the H.pylori stool antigen test. The study population will include all patients who tested positive for H.pylori both by serology and stool antigen tests. Six to eight weeks and 6 month after administration of radioactive iodine (131I) treatment , stool antigen or H.pylori will be tested again to confirm persistence of H.pylori eradication.

    Main Outcome Measure confirmed H.pylori eradication by the stool antigen test. The rate of infection with virulent and caricogenic CagA H.pylori ,will be tested using the immunoblot assay.

    Summary

    We will test in this study whether Helicobacter pylori is eradicated, after radioactive iodine (131I) administration, from the stomach of patients with thyroid diseases. The rate of CagA virulent and carcinogenic H.pylori infection in theses patients will be assessed.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    120 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Effect of Radioactive Iodine on Eradication of Helicobacter Pylori in Patients Treated for Thyroid Diseases
    Study Start Date :
    Feb 1, 2009

    Outcome Measures

    Primary Outcome Measures

      Secondary Outcome Measures

      1. To determine whether CagA helicobacter pylori infection is more prevalent in patients with thyroid diseases compared to other thyroid diseases [2 years]

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years to 85 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      Inclusion Criteria:
      • Adult patients between the ages of 18 and 80.

      • Patients with diagnosed thyroid disease referred for thyroid scan or treatment with radioactive iodine (131I).

      • Patients who provide informed consent

      Exclusion Criteria:
      • Patients without diagnosed thyroid disease.

      • Patients who are pregnant or breast feeding.

      • Patients who have received previous treatment for H. pylori infection.

      • Patients taking proton pump inhibitors.

      • Patients with recent or current use of antibiotics.

      • Patients allergic to iodine (131I).

      Contacts and Locations

      Locations

      No locations specified.

      Sponsors and Collaborators

      • Rabin Medical Center

      Investigators

      None specified.

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00822289
      Other Study ID Numbers:
      • 5071
      First Posted:
      Jan 14, 2009
      Last Update Posted:
      Jan 14, 2009
      Last Verified:
      Jan 1, 2009

      Study Results

      No Results Posted as of Jan 14, 2009