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
  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

Resource links provided by NLM:


Further study details as provided by Rabin Medical Center:

Secondary Outcome Measures:
  • 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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  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 July 28, 2014