Helicobacter Pylori InfectionNCT04984382
Comparison of the Effect of Helicobacter Pylori Eradication Before and After the Training of Gastroenterologists
A study testing Standardized training on Helicobacter pylori eradication treatment in people with Helicobacter Pylori Infection, run by Shandong University at 1 site in China.
Trial summary
The researchers recruited gastroenterologists. Physician subjects recruited Helicobacter pylori-positive patients before and after receiving standardized training on Helicobacter pylori eradication. There are no restrictions on treatment options and drugs during the trial. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Standardized training on Helicobacter pylori eradication treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 26 Jul 2021to Sep 2022
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 1.Physician specialized in gastroenterology.
- 2.Diagnosis and treatment conditions for H. pylori exist in the hospital where the gastroenterology doctor is located.
- (C13 urea breath test, C14 urea breath test, rapid urease test, stool H. pylori antigen test, histopathological test, H. pylori culture, any of the above)
Who cannot join
- 1.Those who are unable or unwilling to provide informed consent.
- 2.Patients with H. pylori have never been diagnosed and treated.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiuli Zuo
Jinan, Shandong, 257000
Xiuli Zuo, MD,PhD, 15588818685 ext. 053188369277, zuoxiuli@sina.com
About this study
Official title: Comparison of the Effect of Helicobacter Pylori Eradication Before and After the Training of Gastroenterologists on Standardized Helicobacter Pylori Eradication Therapy
The researchers recruited gastroenterologists. Physician subjects recruited Helicobacter pylori-positive patients before and after receiving standardized training on Helicobacter pylori eradication. There are no restrictions on treatment options and drugs during the trial. Compare the eradication rate, adverse reaction rate, and patient compliance before and after physician training.
Read the detailed description
The researchers recruited gastroenterologists to participate in the study, and gastroenterologists recruited Helicobacter pylori-positive patients. In this process, the patient population is not limited, and the eradication program is not limited. Gastroenterologists can follow up or not follow up according to their original diagnosis and treatment. Researchers follow up and record the patient's medication status and adverse reactions in the medication process by phone or WeChat, and evaluate patient compliance. Record the eradication rate. After waiting for all patients admitted by gastroenterologists to be eradicated and re-examined, we will provide standardized Helicobacter pylori eradication training for gastroenterologist subjects. After the training, gastroenterologists recruit Helicobacter pylori-positive patients here. In this process, the patient population is not limited, and the eradication program is not limited. Gastroenterologists can follow up or not follow up according to their original diagnosis and treatment. Researchers follow up and record the patient's medication status and adverse reactions in the medication process by phone or WeChat, and evaluate patient compliance. Record the eradication rate. Compare the eradication rate, the incidence of adverse reactions, and the compliance of the patients before and after the training of the gastroenterologists.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Standardized training on Helicobacter pylori eradication treatment
- Keywords
- Standardized training on Helicobacter pylori eradication, Gastroenterologist
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized training on Helicobacter pylori eradication treatmentBehavioural
Standardized training on Helicobacter pylori eradication treatment
| Study group | Role | What they receive |
|---|---|---|
| After receiving standardized training on Helicobacter pylori eradication | Experimental | After the gastroenterologists receive standardized training to eradicate Helicobacter pylori, they recruit Helicobacter pylori-positive patients for treatment. Receives: Behavioral: Standardized training on Helicobacter pylori eradication treatment |
| Before receiving standardized training on Helicobacter pylori eradication | No intervention | Gastroenterologists recruited patients with Helicobacter pylori positive for treatment before receiving standardized training on Helicobacter pylori eradication. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rate
The eradication rate of before and after the gastroenterologists receiving standardized Helicobacter pylori eradication training
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start26 Jul 2021
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiuli Zuo, Shandong University
- Investigators
- Xiuli Zuo, MD,PhD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04984382
- Sponsor's protocol ID
- 2021SDU-QILU-G004
- Status last verified
- Nov 2021
- First submitted
- 27 Jul 2021
- Last updated
- 16 Nov 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 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Helicobacter Pylori Eradication Before and After the Training of Gastroenterologists on Standardized Helicobacter Pylori Eradication Therapy
- ClinicalTrials.gov ID
- NCT04984382
- Acronym / sponsor ID
- 2021SDU-QILU-G004
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Standardized training on Helicobacter pylori eradication, Gastroenterologist
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 26 Jul 2021 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 30 Jul 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.
The researchers recruited gastroenterologists. Physician subjects recruited Helicobacter pylori-positive patients before and after receiving standardized training on Helicobacter pylori eradication. There are no restrictions on treatment options and drugs during the trial. Compare the eradication rate, adverse reaction rate, and patient compliance before and after physician training.
Detailed description
The researchers recruited gastroenterologists to participate in the study, and gastroenterologists recruited Helicobacter pylori-positive patients. In this process, the patient population is not limited, and the eradication program is not limited. Gastroenterologists can follow up or not follow up according to their original diagnosis and treatment. Researchers follow up and record the patient's medication status and adverse reactions in the medication process by phone or WeChat, and evaluate patient compliance. Record the eradication rate. After waiting for all patients admitted by gastroenterologists to be eradicated and re-examined, we will provide standardized Helicobacter pylori eradication training for gastroenterologist subjects. After the training, gastroenterologists recruit Helicobacter pylori-positive patients here. In this process, the patient population is not limited, and the eradication program is not limited. Gastroenterologists can follow up or not follow up according to their original diagnosis and treatment. Researchers follow up and record the patient's medication status and adverse reactions in the medication process by phone or WeChat, and evaluate patient compliance. Record the eradication rate. Compare the eradication rate, the incidence of adverse reactions, and the compliance of the patients before and after the training of the gastroenterologists.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| After receiving standardized training on Helicobacter pylori eradication | Experimental | Behavioral: Standardized training on Helicobacter pylori eradication treatmentAfter the gastroenterologists receive standardized training to eradicate Helicobacter pylori, they recruit Helicobacter pylori-positive patients for treatment. |
| Before receiving standardized training on Helicobacter pylori eradication | No intervention | –Gastroenterologists recruited patients with Helicobacter pylori positive for treatment before receiving standardized training on Helicobacter pylori eradication. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 1.Physician specialized in gastroenterology.
- 2.Diagnosis and treatment conditions for H. pylori exist in the hospital where the gastroenterology doctor is located.
- (C13 urea breath test, C14 urea breath test, rapid urease test, stool H. pylori antigen test, histopathological test, H. pylori culture, any of the above)
Key exclusion criteria (2 listed)
- 1.Those who are unable or unwilling to provide informed consent.
- 2.Patients with H. pylori have never been diagnosed and treated.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized training on Helicobacter pylori eradication treatmentStandardized training on Helicobacter pylori eradication treatment | Behavioural | After receiving standardized training on Helicobacter pylori eradication |
Primary outcome
Eradication rate
Time frame: 1 year
The eradication rate of before and after the gastroenterologists receiving standardized Helicobacter pylori eradication training
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
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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.
Xiuli Zuo, MD,PhD principal investigator
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized training on Helicobacter pylori eradication treatment in people with 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 3 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: status not confirmed, as of the sponsor's last update on 16 Nov 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiuli Zuo, MD, PhD (86 15588818685 ext. 0531-88369277, zuoxiuli@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eradication rate (time frame: 1 year). 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 Nov 2021.