- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00155623
Establish Epidemiologic Data of H. Pylori Infection in Children and Adolescents-Using C13-UBT
October 19, 2005 updated by: National Taiwan University Hospital
Establish the Precise Epidemiologic Data of Helicobacter Pylori Infection in Children and Adolescents - Using the 13C-Urea Breath Test
The aims of this prospective study are: (1) to prospectively investigate the "true" prevalence rate, the acquisition and spontaneous clearance of H. pylori infection year by year in the population whose ages between seven and fifteen.
(2) to explore the risk factors of transmission of H. pylori infection in Taiwan.
(This information may be use as the guide for conduction of the national policy of public health and disease prevention.)
Study Overview
Status
Completed
Conditions
Detailed Description
Helicobacter pylori (H.
pylori), a spiral microaerophilic Gram-negative bacterium isolated in 1983, is now known as the most common gastrointestinal bacterial infection worldwide.
It is the principal cause of chronic gastritis and is strongly associated with peptic ulcer disease as well as gastric cancer, including gastric lymphoma (MALT type).
In developed countries, infection occurs in more than 50% of adults, whereas developing countries have infection rates reaching 90%.
Among those with H. pylori infection, eradication therapy alters the natural history of recurrences with attendant morbidity and death, which previously required lifelong maintenance therapy.
Perhaps the greatest concern with regard to infection with H. pylori is the increased risk for the development of gastric cancers in adulthood.
This is particularly relevant because infection dating from childhood appears to enhance the risk of carcinogenesis.
Because H. pylori infection is contracted primarily during the childhood years, additional epidemiological studies among pediatric populations are imperative.
Therefore the validation of an inexpensive, easy-to perform, sensitive, specific, and noninvasive diagnostic test for H. pylori infection in children and adolescents is of paramount importance to enhance our presently limited understanding of H. pylori-related diseases.
The optimal noninvasive tests for epidemiological research of H. pylori infection in children are still not well identified.
Serologic immunoassays based on H. pylori antigens require validation in the pediatric population under evaluation.
As the result of our previous study, the serological test was not sensitive enough as an epidemiology screening tool for H. pylori infection in children.The aims of this prospective study are: (1) to prospectively investigate the "true" prevalence rate, the acquisition and spontaneous clearance of H. pylori infection year by year in the population whose ages between seven and fifteen.
(2) to explore the risk factors of transmission of H. pylori infection in Taiwan.
(This information may be use as the guide for conduction of the national policy of public health and disease prevention.)
The study population will include students of one primary school and one junior high school in Lo-Tong area.
There will be 150-160 cases in each age group and will be continuously followed-up for 3 years.
Blood sample will be collected from each student for the serological test.
13C-urea breath test will be performed in each student, too.
The parents of students will answer a questionnaire concerning the basic epidemiological data and possible factors related to the transmission of H. pylori.
The students having new acquisition of H. pylori infection in the 2nd or 3rd years' follow-up period will be collected for further investigation.
These student and their family will be invited to receive panendoscopy for the evaluation of possible pathology of stomach and the isolation H. pylori strain.
These H. pylori isolates will be identified by molecular genotyping for the detection of possible source of transmission in the family.
All of these results will be analyzed by a SAS system.
Study Type
Observational
Enrollment
3000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Taipei, Taiwan, 100
- Department of Internal Medicine, National Taiwan University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 60 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age from 6 to 15 years, both male and female. Teachers as adult control.
Exclusion Criteria:
- none
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jyh-Chin Yang, M.D., Department of Internal Medicine, National Taiwan University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2001
Study Completion
July 1, 2003
Study Registration Dates
First Submitted
September 9, 2005
First Submitted That Met QC Criteria
September 9, 2005
First Posted (Estimate)
September 12, 2005
Study Record Updates
Last Update Posted (Estimate)
October 20, 2005
Last Update Submitted That Met QC Criteria
October 19, 2005
Last Verified
January 1, 2001
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24642
- DOH90-DC-1031
- DOH91-DC-1021
- DOH92-DC-1051
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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