Epidemiology of Helicobacter Pylori Infection Among Shang... | NCT02160860

Studies
Epidemiology of Helicobacter Pylori Infection Among Shanghai Children

NCT02160860

Sponsor

Children's Hospital of Fudan University

Status

Completed

Last Update Posted

Aug 16, 2016Estimated

Enrollment

1,997Actual

Phase

Not provided

Conditions

Bacterial Infection Due to Helicobacter Pylori (H. Pylori)

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2014

Primary Completion Date

Sep 2015Actual

Completion Date

Jun 2016Actual

First Submitted Date

Jun 4, 2014

First Submission Date that Met QC Criteria

Jun 10, 2014

First Posted Date

Jun 11, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 14, 2016

Last Update Posted Date

Aug 16, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ying HUANG, Director of Gastroenterology of Children's Hospital of Fudan University, Children's Hospital of Fudan UniversityPrincipal Investigator

Lead Sponsor

Children's Hospital of Fudan UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Epidemiology of Helicobacter Pylori Infection Among Shanghai Children.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,997Actual

Label	Type	Description	Intervention Names
Children		Children

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 3~18
Not been Clinical diagnosis of

Exclusion Criteria:

Had antibiotics in the past week
Had Bismuth or PPI

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Age 3~18 children

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
HAUNG Ying, Doctor	Director of GI Department of Children's Hospital of Fudan University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pujiang Community Health Service Center		Shanghai	Shanghai Municipality	201112	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided