Helicobacter Pylori InfectionNCT04918134
Investigation on Diagnosis and Treatment of Helicobacter Pylori Infection by Gastroenterologists in Shandong Province
An observational study of Helicobacter Pylori Infection, run by Shandong University at 1 site in China.
Trial summary
Helicobacter pylori can lead to a variety of digestive system diseases.The eradication of Helicobacter pylori plays an importment role for the treatment of gastrointestinal ulcer and prevention of gastric cancer .Compared with other countries and regions in the world, the infection rate of Helicobacter pylori in China… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Helicobacter Pylori Infection
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2021to 7 Oct 2021
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Stratified sampling was carried out from all the secondary and tertiary general hospitals in Shandong province, and 120 hospitals were selected.Exclude those without gastroenterology department and those that refused to sign the informed consent, and all gastroenterologists in the hospitals were investigated.
Who may be able to join
- All the gastroenterologists in secondary and tertiary general hospitals of Shandong province
Who cannot join
- A hospital that does not include gastroenterology
- Hospitals and gastroenterologists that refuse to sign informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Helicobacter pylori can lead to a variety of digestive system diseases.The eradication of Helicobacter pylori plays an importment role for the treatment of gastrointestinal ulcer and prevention of gastric cancer .Compared with other countries and regions in the world, the infection rate of Helicobacter pylori in China can reach more than 50%. The non-standard diagnosis and treatment of Helicobacter pylori greatly reduces its eradication rate and increases its drug resistance.Therefore, it is very important to strengthen the standardization of diagnosis and treatment to improve the eradication rate.
The purpose of this study is to investigate the diagnosis and treatment status of Helicobacter pylori among gastroenterologists in general hospitals in Shandong Province.It can help us to understand the actual situation of diagnosis and treatment of Helicobacter pylori in hospitals at all levels, and to provide targeted diagnosis and treatment training for doctors.
- Conditions
- Helicobacter Pylori Infection
- Keywords
- questionnaire, Helicobacter Pylori Infection, cross-sectional survey
What is being measured
The primary outcome is the main question the study is designed to answer.
the results of the questionnaires
the results of each question of the questionnaires
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start10 Jul 2021
- Primary completion20 Aug 2021
- Study completion7 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiuli Zuo, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04918134
- Sponsor's protocol ID
- 2021-SDU-QILU-G002
- Status last verified
- Oct 2021
- First submitted
- 2 Jun 2021
- Last updated
- 19 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on Diagnosis and Treatment of Helicobacter Pylori Infection by Gastroenterologists in Shandong Province
- ClinicalTrials.gov ID
- NCT04918134
- Acronym / sponsor ID
- 2021-SDU-QILU-G002
- Conditions
- Helicobacter Pylori Infection
- Keywords
- questionnaire, Helicobacter Pylori Infection, cross-sectional survey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 10 Jul 2021 (actual)
- Primary completion
- 20 Aug 2021 (actual)
- Study completion
- 7 Oct 2021 (actual)
- First posted
- 8 Jun 2021 (actual)
- 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.
Helicobacter pylori can lead to a variety of digestive system diseases.The eradication of Helicobacter pylori plays an importment role for the treatment of gastrointestinal ulcer and prevention of gastric cancer .Compared with other countries and regions in the world, the infection rate of Helicobacter pylori in China can reach more than 50%. The non-standard diagnosis and treatment of Helicobacter pylori greatly reduces its eradication rate and increases its drug resistance.Therefore, it is very important to strengthen the standardization of diagnosis and treatment to improve the eradication rate.
The purpose of this study is to investigate the diagnosis and treatment status of Helicobacter pylori among gastroenterologists in general hospitals in Shandong Province.It can help us to understand the actual situation of diagnosis and treatment of Helicobacter pylori in hospitals at all levels, and to provide targeted diagnosis and treatment training for doctors.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Stratified sampling was carried out from all the secondary and tertiary general hospitals in Shandong province, and 120 hospitals were selected.Exclude those without gastroenterology department and those that refused to sign the informed consent, and all gastroenterologists in the hospitals were investigated.
Key inclusion criteria (1 listed)
- All the gastroenterologists in secondary and tertiary general hospitals of Shandong province
Key exclusion criteria (2 listed)
- A hospital that does not include gastroenterology
- Hospitals and gastroenterologists that refuse to sign informed consent
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
the results of the questionnaires
Time frame: 2 months
the results of each question of the questionnaires
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 19 Oct 2021.
Related trials for Helicobacter Pylori Infection
RecruitingPhase 3
Keverprazan-Minocycline Dual Therapy of Different Durations Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.
Helicobacter Infection
RecruitingPhase 1
Impact of Eradication Therapy on Helicobacter Pylori Infection With Chronic Obstructive Pulmonary Disease:
Chronic Obstructive Pulmonary Disease (COPD), With Poitive H Pylori
RecruitingObservational study
Feasibility and Performance of FFPE qPCR for Detection of Clarithromycin Resistance in Helicobacter Pylori
HELICOBACTER PYLORI INFECTIONS
RecruitingPhase 4
Efficacy and Safety of Linarazen Gluconate Capsules Combined With Amoxicillin (Dual-Drug Therapy) Versus Bismuth-Containing Quadruple Therapy for First-Line Eradication of Helicobacter Pylori Infection
HELICOBACTER PYLORI INFECTIONS
Not yet recruitingObservational study
European Implementation Study on Simultaneous Screening for Gastric and Colorectal Cancers
Helicobacter Pylori Infection, Colorectal Cancer
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Helicobacter Pylori Infection, run by Shandong 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 1 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 19 Oct 2021. 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?
the results of the questionnaires (time frame: 2 months). 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 19 Oct 2021.