NCT02160860

Brief Summary

Epidemiology of Helicobacter Pylori Infection Among Shanghai Children.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,997

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 4, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 11, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

August 16, 2016

Status Verified

August 1, 2016

Enrollment Period

1.3 years

First QC Date

June 4, 2014

Last Update Submit

August 14, 2016

Conditions

Bacterial Infection Due to Helicobacter Pylori (H. Pylori)

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

Children

Children

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Age 3\~18 children

You may qualify if:

  • Age 3\~18
  • Not been Clinical diagnosis of

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pujiang Community Health Service Center

Shanghai, Shanghai Municipality, 201112, China

Location

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.

Study Officials

  • HAUNG Ying, Doctor

    Director of GI Department of Children's Hospital of Fudan University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Gastroenterology of Children's Hospital of Fudan University

Study Record Dates

First Submitted

June 4, 2014

First Posted

June 11, 2014

Study Start

May 1, 2014

Primary Completion

September 1, 2015

Study Completion

June 1, 2016

Last Updated

August 16, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)