Bacterial Infection Due to Helicobacter Pylori (H. Pylori)NCT02160860
Epidemiology of Helicobacter Pylori Infection Among Shanghai Children
An observational study of Bacterial Infection Due to Helicobacter Pylori (H. Pylori), run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
Epidemiology of Helicobacter Pylori Infection Among Shanghai Children. Read more about this study
- Who is it for?
- Ages 3 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Bacterial Infection Due to Helicobacter Pylori (H. Pylori)
- How many people
- 1,997 participants
- Where
- 1 siteChina
- Study dates
- May 2014to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Age 3~18 children
Who may be able to join
- Age 3~18
- Not been Clinical diagnosis of
Who cannot join
- Had antibiotics in the past week
- Had Bismuth or PPI
Trial locations and contacts
1 site in 1 country.
China1 site
Pujiang Community Health Service Center
Shanghai, Shanghai Municipality, 201112
About this study
Epidemiology of Helicobacter Pylori Infection Among Shanghai Children.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children | Children |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Sampling complete before June 30, 2014. Lab test finish within 10 weeks. Report release within 3 weeks after all test finished.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionSep 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial Infection Due to Helicobacter Pylori (H. Pylori)Studies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 1,997 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying HUANG, Children's Hospital of Fudan University
- Investigators
- HAUNG Ying, Doctor, Study director, Director of GI Department of Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02160860
- Sponsor's protocol ID
- HY201405-HP
- Status last verified
- Aug 2016
- First submitted
- 4 Jun 2014
- Last updated
- 16 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiology of Helicobacter Pylori Infection Among Shanghai Children
- ClinicalTrials.gov ID
- NCT02160860
- Acronym / sponsor ID
- HY201405-HP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,997 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 11 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children | – | –Children |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Age 3~18 children
Key inclusion criteria (2 listed)
- Age 3~18
- Not been Clinical diagnosis of
Key exclusion criteria (2 listed)
- Had antibiotics in the past week
- Had Bismuth or PPI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2016.
- Individual participant dataSharing planned: No
Related trials for Bacterial Infection Due to Helicobacter Pylori (H. Pylori)
Active, not recruitingObservational study
Changes Associated With H. Pylori and Gastric Carcinogenesis
Bacterial Infection Due to Helicobacter Pylori (H. Pylori)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
HAUNG Ying, Doctor study director
Director of GI Department of Children's Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacterial Infection Due to Helicobacter Pylori (H. Pylori), run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2016.