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Epidemiology of Helicobacter Pylori Infection Among Shanghai Children

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ClinicalTrials.gov Identifier: NCT02160860
Recruitment Status : Completed
First Posted : June 11, 2014
Last Update Posted : August 16, 2016
Sponsor:
Information provided by (Responsible Party):
Ying HUANG, Children's Hospital of Fudan University

Brief Summary:
Epidemiology of Helicobacter Pylori Infection Among Shanghai Children.

Condition or disease
Bacterial Infection Due to Helicobacter Pylori (H. Pylori)

Detailed 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.

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Study Type : Observational
Actual Enrollment : 1997 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: Epidemiology of Helicobacter Pylori Infection Among Shanghai Children
Study Start Date : May 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Group/Cohort
Children
Children



Primary Outcome Measures :
  1. HP Infection Rate Estimation for Shanghai Children [ Time Frame: Sampling complete before June 30, 2014. Lab test finish within 10 weeks. Report release within 3 weeks after all test finished. ]
    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


Biospecimen Retention:   Samples Without DNA
serum will be storage in to -80℃ fridge for further test. other biospecimen will be test at site and disposed.


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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Age 3~18 children
Criteria

Inclusion Criteria:

  • Age 3~18
  • Not been Clinical diagnosis of

Exclusion Criteria:

  • Had antibiotics in the past week
  • Had Bismuth or PPI

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02160860


Locations
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China, Shanghai
Pujiang Community Health Service Center
Shanghai, Shanghai, China, 201112
Sponsors and Collaborators
Children's Hospital of Fudan University
Investigators
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Study Director: HAUNG Ying, Doctor Director of GI Department of Children's Hospital of Fudan University
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Responsible Party: Ying HUANG, Director of Gastroenterology of Children's Hospital of Fudan University, Children's Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT02160860    
Other Study ID Numbers: HY201405-HP
First Posted: June 11, 2014    Key Record Dates
Last Update Posted: August 16, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Bacterial Infections