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NCT02160860 Clinical Trial

Epidemiology of Helicobacter Pylori Infection Among Shanghai Children

Bacterial Infection Due to Helicobacter Pylori (H. Pylori) Clinical Trial

Official title:
Epidemiology of Helicobacter Pylori Infection Among Shanghai Children

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02160860
Other study ID # HY201405-HP
Secondary ID
Status Completed
Phase N/A
First received June 4, 2014
Last updated August 14, 2016
Start date May 2014
Est. completion date June 2016

Study information
Verified date August 2016
Source Children's Hospital of Fudan University
Contact n/a
Is FDA regulated No
Health authority China: Ministry of Health
Study type Observational

Clinical Trial Summary

Epidemiology of Helicobacter Pylori Infection Among Shanghai Children.

Description:

To get an understanding of the Hp infection general situation and provide evidence for Hp control, we are planning to run a free physical examination and lab test for a group of children. We are going to proceed with Hp-IgG test, 13C urea breath test and salivary Hp urea antigen test together to screening and diagnosing it.

Recruitment information / eligibility
Status Completed
Enrollment 1997
Est. completion date June 2016
Est. primary completion date September 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 3 Years to 18 Years
Eligibility Inclusion Criteria:

- Age 3~18

- Not been Clinical diagnosis of

Exclusion Criteria:

- Had antibiotics in the past week

- Had Bismuth or PPI

Study Design

Observational Model: Ecologic or Community, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
China Pujiang Community Health Service Center Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary HP Infection Rate Estimation for Shanghai Children Get the population of infection with HP and calculate the infection rate for the sampling group, to estimate the infection rate for whole population of Shanghai children Sampling complete before June 30, 2014. Lab test finish within 10 weeks. Report release within 3 weeks after all test finished. No
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