Reinfection After Eradication of Helicobacter Pylori Infection (RAEHPI)

February 3, 2016 updated by: Lingyu Luo, The First Affiliated Hospital of Nanchang University

Reinfection After Eradication of Helicobacter Pylori Infection in Adult :A National Multicentre Study

Helicobacter pylori is closely related with gastritis, peptic ulcer, gastric cancer and gastric MALT lymphoma, and it may participate in a variety of parenteral diseases. Infection rates of Helicobacter pylori is still high, so effectively eradication is necessary. At present, the eradication therapy has achieved very good curative effect. However, relapse after eradication is unoptimistic. This study has made an analysis for reinfection after eradication of Helicobacter pylori Infection include the retrospective and prospective studies, aims to explore the epidemiological data and related risk factors of Hp reinfection in China.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

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.

Detailed Description

In the retrospective study,we choose the people received regular eradication therapy, successfully eradicated helicobacter pylori more than six months, but 4 to 8 weeks after drug withdrawal ,the detection result of helicobacter pylori were negative to ensure that the results of the study is the reinfection, not residual. Even more noteworthy is during the treatment and detection again, the patients must not received any eradication therapy of Hp. What's more , before the detection, they also has not used antibiotics, bismuth agent and the traditional Chinese medicine with antibacterial effect in 1 monthor and has not used H2RA and PPI in 2 weeks to prevent affecting the accuracy of the results. At the same time, we also investigated the patient's general situation, conomic conditions, living conditions, personal health and lifestyle to explore related risk factors of Hp reinfection in China. In the prospective study, we detected Hp by C-UBT after regular eradication therapy of Hp for 4 weeks, 8 weeks and 6 months to prospect the reinfection of Hp.It also can make up the defects of retrospective study.

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.
3500

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • Affiliated Hospital of Nanchang 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

Non-Probability Sample

Study Population

In the retrospective study,people who has infected helicobacter pylori and successfully eradicated it more than six months detected helicobacter pylori by the C-urea breath test in order to evaluate the reinfection In the prospective study,people who has infected helicobacter pylori received regular eradication therapy after the 4 weeks, 8 weeks and 6 months detected helicobacter pylori by the C-urea breath test in order to prospect the reinfection

Description

Inclusion Criteria:

-1、Retrospective study：

  1. Received regular eradication therapy, 4 to 8 weeks after drug withdrawal , detected of helicobacter pylori and the results were negative
  2. Eradication program and original disease is unlimited
  3. Without any eradication therapyof Hp during the treatment and detection again
  4. before the detection has not used antibiotics, bismuth agent and the traditional Chinese medicine with antibacterial effect in 1 monthor and has not used H2RA and PPI in 2 weeks.

2、Prospective study

  1. Infected with H. pylori that detected by C-UBT
  2. With out alimentary tract hemorrhage,ulceration and complications of eradication
  3. Eradication program and original disease is unlimited

Exclusion Criteria:

  1. Pregnancy or breast-feeding women
  2. With the major disease which would influence the research such as liver disease, heart disease, kidney disease, malignant tumor and alcohol poisoning
  3. Participated in other drug research in the past three months
  4. The patient can't express himself correctly such as mental illness and severe neurosis and can't cooperation this test

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?

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.
Retrospective study
People who has successfully eradicated helicobacter pylori more than six months detected helicobacter pylori by the C-urea breath test in order to evaluate the reinfection.
Prospective study
People who has infected helicobacter pylori received regular eradication therapy after the 4 weeks, 8 weeks and 6 months detected helicobacter pylori by the C-urea breath test in order to prospect the reinfection .

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
Helicobacter Pylori Infection
Time Frame: six months
Retrospective study
six months
Helicobacter Pylori Infection
Time Frame: After regular eradication therapy of Hp for 4 weeks, 8 weeks and 6 months
Prospective study
After regular eradication therapy of Hp for 4 weeks, 8 weeks and 6 months

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.
The First Affiliated Hospital of Nanchang University

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

Helpful Links

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

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.
December 1, 2015

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.
March 1, 2016

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.
September 1, 2016

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).
February 2, 2016

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.
February 3, 2016

First Posted (Estimate)

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.
February 4, 2016

Study Record Updates

Last Update Posted (Estimate)

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.
February 4, 2016

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.
February 3, 2016

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.
February 1, 2016

More Information

Terms related to this study

Keywords

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.
  • Affiliated Hospital of NCU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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