Helicobacter PyloriNCT04956679
Family-based Screening and Treatment of Helicobacter Pylori：A Real World Study
An observational study of Helicobacter Pylori and Family, run by Shandong University at 1 site in China.
Trial summary
The habit of family meals makes the infection rate of Helicobacter pylori high in China, which is also the main cause of reinfection of Helicobacter pylori. Eating together can easily cause family members to be infected with Helicobacter pylori. Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori, Family
- What is being tested?
- carbon 13 breath test
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2021to Jun 2022
- How long will I take part?
- 2 Months
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Community population aged above 3 years in family unit,The family unit is determined by actual living together rather than household registration relationship, with at least 2 people in the family and living together for at least 10 months each year in the past 5 years.
Who may be able to join
- Community population over 3 years old who signed the informed consent.
- at least 2 people in the family.
- living together for at least 10 months each year in the past 5 years except child aged below 5.
Who cannot join
- PPI drugs such as esomeprazole、pantoprazole、 rabeprazole,、lansoprazole、famotidine and H2 receptor antagonists were taken within two weeks.
- antibiotics、bismuth agents or traditional Chinese medicine with antibacterial effect were taken within four weeks
- There are other factors that researchers think are not suitable for participation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Gastroenterology,QiLu Hospital,Shandong University
Jinan, Shandong, 250012
Yanqing Li, MD,PhD, 86-531-82169236, liyanqing@sdu.edu.cn
About this study
The habit of family meals makes the infection rate of Helicobacter pylori high in China, which is also the main cause of reinfection of Helicobacter pylori. Eating together can easily cause family members to be infected with Helicobacter pylori. We used a real-world study to understand the risk factors, epidemiological characteristics, and safety and effectiveness of eradication therapy for helicobacter pylori infection in family-based screening and treatment.
Read the detailed description
Helicobacter pylori infection is a worldwide problem, which is the main cause of gastric cancer. The habit of sharing meals in the family is one of the factors contributing to the high infection rate of HP in China, as well as the main cause of reinfection of HP. Sharing meals can easily cause family members to be infected with HP.Family members live together, eat together, share tableware and other behaviors through the "mouth to mouth" transmission of Helicobacter pylori may be infected with each other, is also one of the reasons for the eradication of many patients after re-infection.At the same time, repeated infection and treatment of Helicobacter pylori will increase the difficulty of Helicobacter pylori reeradication.As a family unit, to study the status of our country family helicobacter pylori infection, epidemiological characteristics, infection risk factor, the different schemes, such as the safety and efficacy of treatment to take measures to reduce the infection rate is of great significance to prevention and treatment of gastric cancer.
- Conditions
- Helicobacter Pylori, Family
- Being tested
- carbon 13 breath test
- Keywords
- Helicobacter pylori, Family
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbon 13 breath testDiagnostic test
Patients with positive Helicobacter pylori infection were determined by carbon 13 breath test ,The diagnosis and treatment of positive patients were followed up without other intervention.
| Study group | Role | What they receive |
|---|---|---|
| Family members in the study | Community groups that meet the inclusion criteria Receives: Diagnostic Test: carbon 13 breath test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient compliance of performing medical examination.
Good compliance of medical examination advice was defined as the subjects took the medical advice given by the doctor and the rate of adoption and implementation of the medical examination advice.
Measured: 1 year
Patient compliance of taking medication
Patient compliance of taking medication is defined as the ratio of the actual dose of medication taken by the patient to the total amount of medication required by the prescription. Good medication compliance is defined as the ratio greater than 80%.
Measured: 1 year
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Adverse reactions related to medication were recorded
Measured: 1 year
Lesion detection ratio
The lesion detection ratio was defined as the ratio of the number of subjects who underwent medical examination on the basis of doctor's recommendation and were finally diagnosed with lesion to the number of subjects who underwent examination.
Measured: 1 year
Eradication rate
Eradication rate was defined as the ratio of the number of patients diagnosed positive on the carbon 13 breath test to the number of subjects who turned negative after taking the eradication drug to the number of subjects diagnosed positive before taking the drug.
Measured: 1 year
Secondary outcomes (1)
The high-risk factors of Helicobacter pylori infection in families were investigated by questionnaire statistics.
Questionnaire survey was used to conduct information statistics on families undergoing Helicobacter pylori screening.Statistics include family members of the general situation, basic information, personal health and life habit, individual disease history, personal nearly 1 month medications, family health and lifestyle, family history, history of HP infection and the eradication of history, screening results, doctor give opinions and patient adherence and follow-up outcome after screening process, etc. Statistical soft ware was used to analyze factor correlations.
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 posted9 Jul 2021
- Study start10 Jul 2021
- Primary completionMay 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Helicobacter PyloriStudies 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
- Family based
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
- Investigators
- Li Yanqing, PhD, Study chair, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956679
- Sponsor's protocol ID
- 2019SDU-QILU-186
- Status last verified
- Oct 2021
- First submitted
- 25 Jun 2021
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liou JM, Malfertheiner P, Lee YC, Sheu BS, Sugano K, Cheng HC, Yeoh KG, Hsu PI, Goh KL, Mahachai V, Gotoda T, Chang WL, Chen MJ, Chiang TH, Chen CC, Wu CY, Leow AH, Wu JY, Wu DC, Hong TC, Lu H, Yamaoka Y, Megraud F, Chan FKL, Sung JJ, Lin JT, Graham DY, Wu MS, El-Omar EM; Asian Pacific Alliance on Helicobacter and Microbiota (APAHAM). Screening and eradication of Helicobacter pylori for gastric cancer prevention: the Taipei global consensus. Gut. 2020 Dec;69(12):2093-2112. doi: 10.1136/gutjnl-2020-322368. Epub 2020 Oct 1.
PubMed 33004546
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-based Screening and Treatment of Helicobacter Pylori：A Real World Study
- ClinicalTrials.gov ID
- NCT04956679
- Acronym / sponsor ID
- 2019SDU-QILU-186
- Conditions
- Helicobacter Pylori, Family
- Keywords
- Helicobacter pylori, Family
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 10 Jul 2021 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 9 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 habit of family meals makes the infection rate of Helicobacter pylori high in China, which is also the main cause of reinfection of Helicobacter pylori. Eating together can easily cause family members to be infected with Helicobacter pylori. We used a real-world study to understand the risk factors, epidemiological characteristics, and safety and effectiveness of eradication therapy for helicobacter pylori infection in family-based screening and treatment.
Detailed description
Helicobacter pylori infection is a worldwide problem, which is the main cause of gastric cancer. The habit of sharing meals in the family is one of the factors contributing to the high infection rate of HP in China, as well as the main cause of reinfection of HP. Sharing meals can easily cause family members to be infected with HP.Family members live together, eat together, share tableware and other behaviors through the "mouth to mouth" transmission of Helicobacter pylori may be infected with each other, is also one of the reasons for the eradication of many patients after re-infection.At the same time, repeated infection and treatment of Helicobacter pylori will increase the difficulty of Helicobacter pylori reeradication.As a family unit, to study the status of our country family helicobacter pylori infection, epidemiological characteristics, infection risk factor, the different schemes, such as the safety and efficacy of treatment to take measures to reduce the infection rate is of great significance to prevention and treatment of gastric cancer.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Target follow-up
- 2 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Family members in the study | – | Diagnostic Test: carbon 13 breath testCommunity groups that meet the inclusion criteria |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Community population aged above 3 years in family unit,The family unit is determined by actual living together rather than household registration relationship, with at least 2 people in the family and living together for at least 10 months each year in the past 5 years.
Key inclusion criteria (3 listed)
- Community population over 3 years old who signed the informed consent.
- at least 2 people in the family.
- living together for at least 10 months each year in the past 5 years except child aged below 5.
Key exclusion criteria (3 listed)
- PPI drugs such as esomeprazole、pantoprazole、 rabeprazole,、lansoprazole、famotidine and H2 receptor antagonists were taken within two weeks.
- antibiotics、bismuth agents or traditional Chinese medicine with antibacterial effect were taken within four weeks
- There are other factors that researchers think are not suitable for participation
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 |
|---|---|---|
| carbon 13 breath testPatients with positive Helicobacter pylori infection were determined by carbon 13 breath test ,The diagnosis and treatment of positive patients were followed up without other intervention. | Diagnostic test | Family members in the study |
Primary outcome
Patient compliance of performing medical examination.
Time frame: 1 year
Good compliance of medical examination advice was defined as the subjects took the medical advice given by the doctor and the rate of adoption and implementation of the medical examination advice.
Patient compliance of taking medication
Time frame: 1 year
Patient compliance of taking medication is defined as the ratio of the actual dose of medication taken by the patient to the total amount of medication required by the prescription. Good medication compliance is defined as the ratio greater than 80%.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 1 year
Adverse reactions related to medication were recorded
Lesion detection ratio
Time frame: 1 year
The lesion detection ratio was defined as the ratio of the number of subjects who underwent medical examination on the basis of doctor's recommendation and were finally diagnosed with lesion to the number of subjects who underwent examination.
Eradication rate
Time frame: 1 year
Eradication rate was defined as the ratio of the number of patients diagnosed positive on the carbon 13 breath test to the number of subjects who turned negative after taking the eradication drug to the number of subjects diagnosed positive before taking the drug.
1 secondary outcome
The high-risk factors of Helicobacter pylori infection in families were investigated by questionnaire statistics.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Background: PubMed 33004546Liou JM, Malfertheiner P, Lee YC, Sheu BS, Sugano K, Cheng HC, Yeoh KG, Hsu PI, Goh KL, Mahachai V, Gotoda T, Chang WL, Chen MJ, Chiang TH, Chen CC, Wu CY, Leow AH, Wu JY, Wu DC, Hong TC, Lu H, Yamaoka Y, Megraud F, Chan FKL, Sung JJ, Lin JT, Graham DY, Wu MS, El-Omar EM; Asian Pacific Alliance on Helicobacter and Microbiota (APAHAM). Screening and eradication of Helicobacter pylori for gastric cancer prevention: the Taipei global consensus. Gut. 2020 Dec;69(12):2093-2112. doi: 10.1136/gutjnl-2020-322368. Epub 2020 Oct 1.
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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.
Li Yanqing, PhD study chair
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?
An observational study of Helicobacter Pylori and Family, 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 3 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 12 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Yanqing, PhD (053182169385, liyanqing@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient compliance of performing medical examination. (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04956679, which also lists 1 linked publication.
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 12 Oct 2021.