The Effect of Time Intervals for Rescue Treatment on Eradication Effect of Helicobacter Pylori Infection

November 10, 2022 updated by: Xiuli Zuo, Shandong University

The Effect of Different Time Intervals on Rescue Treatment of Helicobacter Pylori Infection: a Prospective, Multicenter Observational Study

The researchers collect patients who accepted eradication program of the helicobacter pylori but failed to eradicate helicobacter pylor from the outpatient clinic. After rescue therapy, evaluating the effect of retreatment interval on eradication effect of Helicobacter pylori infection.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The researchers collect patients who accepted eradication program of the helicobacter pylori but failed to eradicate helicobacter pylor from the outpatient clinic. Record the interval between the last eradication therapy and this time，6-8 weeks after treatment, the subjects will re-take the 13C-urea breath test. Calculating the eradication rates, adverse reaction rates, patient compliance of each group. Evaluating the effect of retreatment interval on eradication effect of Helicobacter pylori infection.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
628

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Qilu Hospital, Shandong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The patients in Shandong province,aged between 18 and 70 years old, with positive H. pylori infection that was eradicated by previous therapies but failed are included.

Description

Inclusion Criteria:

  • Patients aged 18-70.
  • Patients with H.pylori infection (Positive for any of the following: 13C/14C-urea breath test, histopathology test, rapid urease test, stool H.pylori antigen test).
  • Patients who have previously received helicobacter pylori eradication therapy and failed.

Exclusion Criteria:

  • Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than 1.5 times the normal value), renal insufficiency (Cr≥2.0mg/dL or glomerular filtration rate <50 ml/min), immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75%.
  • Patients who are pregnant or lactating or unwilling to take contraceptive measures during the trial.
  • Patients with active gastrointestinal bleeding.
  • Patients with a history of upper gastrointestinal surgery.
  • Patients allergic to treatment drugs.
  • Patients with medication history of bismuth agents, antibiotics, proton pump inhibitor and other drugs within 4 weeks
  • Patients with other behaviors that may increase the risk of illness, such as alcohol and drug abuse
  • Patients who are unwilling or incapable to provide informed consents.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Remedial treatment within 3 months
Other: Remedial treatment within 3 months

The interval between the time of this treatment and the last day of the last therapy is within 3 months.Patients in Amoxicillin + Tetracycline + Bismuth + Esomeprazole quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Esomeprazole 40mg bid for 14d.

Patients in Amoxicillin + Tetracycline + Bismuth + Vonoprazan quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Vonoprazan 20mg bid for 14d.

Patients in Amoxicillin + Tetracycline + Bismuth + Tegoprazan quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Tegoprazan 50mg bid for 14d.
Remedial treatment within 3 to 6 months
Other: Remedial treatment within 3 to 6 months

The interval between the time of this treatment and the last day of the last therapy is 3-6 months.

Patients in Amoxicillin + Tetracycline + Bismuth + Esomeprazole quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Esomeprazole 40mg bid for 14d.

Patients in Amoxicillin + Tetracycline + Bismuth + Vonoprazan quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Vonoprazan 20mg bid for 14d.

Patients in Amoxicillin + Tetracycline + Bismuth + Tegoprazan quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Tegoprazan 50mg bid for 14d.
Remedial treatment within 6 to 12 months
Other: Remedial treatment within 6 to 12 months

The interval between the time of this treatment and the last day of the last therapy is 6-12 months Patients in Amoxicillin + Tetracycline + Bismuth + Esomeprazole quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Esomeprazole 40mg bid for 14d.

Patients in Amoxicillin + Tetracycline + Bismuth + Vonoprazan quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Vonoprazan 20mg bid for 14d.

Patients in Amoxicillin + Tetracycline + Bismuth + Tegoprazan quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Tegoprazan 50mg bid for 14d.
Remedial treatment after 12 months
Other: Remedial treatment after 12 months

The interval between the time of this treatment and the last day of the last therapy is more than 12 months Patients in Amoxicillin + Tetracycline + Bismuth + Esomeprazole quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Esomeprazole 40mg bid for 14d.

Patients in Amoxicillin + Tetracycline + Bismuth + Vonoprazan quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Vonoprazan 20mg bid for 14d.

Patients in Amoxicillin + Tetracycline + Bismuth + Tegoprazan quadruple group will receive Amoxicillin 1000mg bid+ Tetracycline 500mg qid/tid + Bismuth + Tegoprazan 50mg bid for 14d.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Eradication rate at different time intervals
Time Frame: immediately after the procedure
Both intention to treat (ITT) and per-protocol (PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in two groups. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.
immediately after the procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Type、Rate and severtiry of adverse reactions
Time Frame: Immediately after the procedure
Type、Rate and severtiry of adverse reactions
Immediately after the procedure
Patient compliance
Time Frame: Immediately after the procedure
Good compliance is defined as the actual dosage is within the range of 80%-100% of the dosage that should be taken.
Immediately after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shandong University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Zibo Central Hospital
Peking University Care Luzhong Hospital
Yuncheng Traditional Chinese Medicine Hospital
Taierzhuang District People's Hospital
Zhengzhou Central Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 11, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 17, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 10, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-SDU-QILU-G007

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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