Helicobacter Pylori Infected PatientsNCT00822289
The Effect of Radioactive Iodine Administration for Thyroid Diseases on H.Pylori Eradication
An observational study of Helicobacter Pylori Infected Patients and Thyroid Cancer Patients, run by Rabin Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Helicobacter Pylori Infected Patients, Thyroid Cancer Patients, Hyperthyroidism
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Feb 2009to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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).
About this study
Official title: Effect of Radioactive Iodine on Eradication of Helicobacter Pylori in Patients Treated for Thyroid Diseases
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.
Read the 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.
- Keywords
- radioactive iodine, Helicobacter pylori, Thyroid diseases, CagA
- Medical subject headings
- Hyperthyroidism, Thyroid Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2009 (estimated)
- Study startFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori Infected PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00822289
- Sponsor's protocol ID
- 5071
- Status last verified
- Jan 2009
- First submitted
- 13 Jan 2009
- Last updated
- 14 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Radioactive Iodine on Eradication of Helicobacter Pylori in Patients Treated for Thyroid Diseases
- ClinicalTrials.gov ID
- NCT00822289
- Acronym / sponsor ID
- 5071
- Keywords
- radioactive iodine, Helicobacter pylori, Thyroid diseases, CagA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Feb 2009
- First posted
- 14 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
1 secondary outcome
To determine whether CagA helicobacter pylori infection is more prevalent in patients with thyroid diseases compared to other thyroid diseases
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Helicobacter Pylori Infected Patients and Thyroid Cancer Patients, run by Rabin Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2009.