The Effect of Radioactive Iodine Administration for Thyroid Diseases on H.Pylori Eradication
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 |
|---|
|
Helicobacter Pylori Infected Patients Thyroid Cancer Patients Hyperthyroidism |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Effect of Radioactive Iodine on Eradication of Helicobacter Pylori in Patients Treated for Thyroid Diseases |
- 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 ]
| Estimated Enrollment: | 120 |
| Study Start Date: | February 2009 |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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.
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 More Information
No publications provided
| Responsible Party: | Haim Shmuely, MD, Rabin Medical Center |
| ClinicalTrials.gov Identifier: | NCT00822289 History of Changes |
| Other Study ID Numbers: | 5071 |
| Study First Received: | January 13, 2009 |
| Last Updated: | January 13, 2009 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Rabin Medical Center:
|
radioactive iodine Helicobacter pylori Thyroid diseases CagA |
Additional relevant MeSH terms:
|
Thyroid Neoplasms Hyperthyroidism Thyroid Diseases Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms Endocrine System Diseases Iodine |
Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013