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

This study is enrolling participants by invitation only.

Sponsor:

Information provided by:

Rabin Medical Center

ClinicalTrials.gov Identifier:

NCT00822289

First received: January 13, 2009

Last updated: NA

Last verified: January 2009

History: No changes posted

Tracking Information
First Received Date ^ICMJE	January 13, 2009
Last Updated Date	January 13, 2009
Start Date ^ICMJE	February 2009
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: January 13, 2009)	To determine whether CagA helicobacter pylori infection is more prevalent in patients with thyroid diseases compared to other thyroid diseases [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	The Effect of Radioactive Iodine Administration for Thyroid Diseases on H.Pylori Eradication
Official Title ^ICMJE	Effect of Radioactive Iodine on Eradication of Helicobacter Pylori in Patients Treated for Thyroid Diseases
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.
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 Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Probability Sample
Study Population	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 tested, 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 on serology and stool antigen tests. Six to eight weeks and 6 month after administration of radioactive iodine (131I) , stool antigen or H.pylori will be tested again to confirm persistence of H.pylori eradication.
Condition ^ICMJE	Helicobacter Pylori Infected Patients Thyroid Cancer Patients Hyperthyroidism
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Enrolling by invitation
Estimated Enrollment ^ICMJE	120
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	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).
Gender	Both
Ages	18 Years to 85 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00822289
Other Study ID Numbers ^ICMJE	5071
Has Data Monitoring Committee	No
Responsible Party	Haim Shmuely, MD, Rabin Medical Center
Study Sponsor ^ICMJE	Rabin Medical Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Rabin Medical Center
Verification Date	January 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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