Epidemiological Investigation of Helicobacter Pylori-infected Patients and the Effect of Eradication Treatment on Dyspepsia Symptoms

December 26, 2024 updated by: Hong Lu, MD, Shanghai Jiao Tong University School of Medicine
The objectives of this multicenter, prospective, observational study were to investigate the incidence of dyspeptic symptoms in patients with Helicobacter pylori (H. pylori) infection and to continuously follow up the remission of dyspeptic symptoms after H. pylori eradication, so as to provide reference for the clinical diagnosis and treatment strategies of patients with H. pylori infection and dyspeptic symptoms.

Study Overview

Status

Status

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

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 (Estimated)

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.
2242

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 Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China
        • Recruiting
        • The People's Hospital of Kaizhou District, CQ
        • Contact:
          • Qiang Wu
          • Phone Number: +8618223960853
      • Chongqing, Chongqing, China
        • Recruiting
        • The Ninth People'S Hospital of Chongqing
        • Contact:
          • Xiaoying Yuan
          • Phone Number: +86 13983850146
      • Chongqing, Chongqing, China
        • Recruiting
        • Chongqing Daping Hospital
        • Contact:
          • Chunhui Lan
          • Phone Number: +86 13896067955
    • Fujian
      • Xiamen, Fujian, China
        • Recruiting
        • The First Affiliated Hospital of Xiamen University
        • Contact:
          • Jinyan Zhang
          • Phone Number: +8615160042319
    • Gansu
      • Wuwei, Gansu, China
        • Recruiting
        • The People's Hospital of Wuwei
        • Contact:
          • Xiaoyun Ma
          • Phone Number: +8613639359150
    • Guangxi
      • Qinzhou, Guangxi, China
        • Recruiting
        • The First People's Hospital of Qinzhou
        • Contact:
          • Meimei Zeng
          • Phone Number: +8615107774335
    • Henan
      • Luoyang, Henan, China
        • Recruiting
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Contact:
          • Yanli Bai
          • Phone Number: +86 13653794460
      • Shangqiu, Henan, China
        • Recruiting
        • Yongcheng People's Hospital of Henan Province
        • Contact:
          • Hongdan Ma
          • Phone Number: +86 13781408747
      • Xuchang, Henan, China
        • Recruiting
        • Xuchang Central Hospital
        • Contact:
          • Shilei Song
          • Phone Number: +86 13837421261
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
          • Jing Li
          • Phone Number: +86 18827603030
    • Inner Mongolia
      • Baotou, Inner Mongolia, China
        • Recruiting
        • Baotou Central Hospital
        • Contact:
          • Qiang Liu
          • Phone Number: +86 15174918099
    • Liaoning
      • Dalian, Liaoning, China
        • Recruiting
        • The First Affiliated Hospital of Dalian Medical University
        • Contact:
          • Lina Liang
          • Phone Number: +8618098875591
      • Dalian, Liaoning, China
        • Recruiting
        • Dalian Friendship Hospital
        • Contact:
          • Fucheng Wang
          • Phone Number: +86 15542626166
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai East Hospital
        • Contact:
          • Qinjuan Sun
          • Phone Number: +86 13681667917
      • Shanghai, Shanghai, China, 200127
        • Recruiting
        • Renji Hospital, School of Medicine, Shanghai Jiao Tong University
        • Contact:
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Construction Group Hospital
        • Contact:
          • Qi Liao
          • Phone Number: +8613512128067
      • Shanghai, Shanghai, China
        • Recruiting
        • Ruijin Hospital Luwan Branch
        • Contact:
          • Xiong Zheng
          • Phone Number: +86 18116292085
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Putuo Liqun Hospital
        • Contact:
          • Lamei Teng
          • Phone Number: +86 13817591903
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Songjiang Central Hospital
        • Contact:
          • Jing Wang
          • Phone Number: +86 18918289144
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • West China Fourth Hospital, Sichuan University
        • Contact:
          • Yan Ou
          • Phone Number: +8615008228212
    • Tianjing
      • Tianjing, Tianjing, China
        • Recruiting
        • First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
        • Contact:
          • Lin Yan
          • Phone Number: +86 18222835795
    • Xinjiang
      • Kashgar, Xinjiang, China
        • Recruiting
        • The Second People's Hospital of Kashgar, Xinjiang
        • Contact:
    • Yunnan
      • Kunming, Yunnan, China
        • Recruiting
        • Second People's Hospital of Jinning District, Kunming City
        • Contact:
          • Zhouhua Li
          • Phone Number: +8613769108442
    • Zhejiang
      • Ningbo, Zhejiang, China
        • Recruiting
        • Ningbo Hangzhou Bay Hospital
        • Contact:
          • Shuliang Zhao
          • Phone Number: +057458993397
      • Ningbo, Zhejiang, China
        • Recruiting
        • The People's Hospital of Shengzhou
        • Contact:
          • Shan Yu
          • Phone Number: +8613456521442
      • Shaoxing, Zhejiang, China
        • Recruiting
        • Shengzhou People's Hospital
        • Contact:
          • Shan Yu
          • Phone Number: +86 13456521442

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population targets male and female patients aged 15-80 who have not previously been treated for Helicobacter pylori and have been diagnosed via 13C/14C urea breath test or gastroscopy. Participants must be willing and able to give informed consent. Exclusions include individuals under 18 or over 80, those with organic digestive diseases, pregnant or nursing women, those with a history of cancer or partial gastrectomy, and individuals with severe organ dysfunction or congenital diseases. Also excluded are those with symptoms like melena, hematemesis, anemia, or cachexia.

Description

Inclusion Criteria:

  • Male or female patients aged 18-80 years
  • H. pylori infection diagnosed by 13C/ 14C-UBT (> 2 times the cutoff value) and/or gastroscopy (rapid urease strong positive and histological positive)
  • Treatment-naive patients with Helicobacter pylori
  • Ability and willingness to participate in the study and to sign and give informed consent

Exclusion Criteria:

  • Under 18 or over 80 years old
  • Organic digestive diseases, such as active peptic ulcer, gastroesophageal reflux, gastrointestinal bleeding, acute/chronic pancreatitis, acute/chronic cholecystitis, gallstones, intestinal obstruction, inflammatory bowel disease, etc.
  • Combined with melena, hematemesis, anemia, emaciation and other alarm symptoms
  • Pregnant and lactating women
  • History of cancer
  • History of subtotal gastrectomy
  • Severe organ dysfunction of heart, liver, kidney, lung and other important organs and congenital diseases, such as grade IV heart failure, liver failure, uremia, respiratory failure, hemophilia, Wilson's disease, etc.

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

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.
Dyspepsia with Helicobacter pylori infection
Other: Epidemiological questionnaire and Functional Dyspepsia Symptom Diary（FDSD）
H. pylori infection was confirmed by 13C/ 14C-breath test and/or rapid urease test under endoscopy and histopathological examination. Epidemiological questionnaire and Functional Dyspepsia Symptom Diary (FDSD) were used to investigate basic information and assess dyspeptic symptoms. Patients with dyspepsia who successfully eradicated Helicobacter pylori infection will be followed up for dyspeptic symptoms after 2 months and 6 months to evaluate the relief of dyspeptic symptoms.

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
the incidence of dyspepsia in patients with Helicobacter pylori infection
Time Frame: Time 0 when finished the Epidemiological questionnaire and Functional Dyspepsia Symptom Diary
Proportion of patients with Helicobacter pylori infection with dyspeptic symptoms
Time 0 when finished the Epidemiological questionnaire and Functional Dyspepsia Symptom Diary
Relief of Helicobacter pylori related dyspepsia
Time Frame: Patients with dyspepsia who have successfully eradicated Helicobacter pylori infection will be followed up for dyspepsia symptoms after 2 months and after 6 months to assess the remission of dyspepsia symptoms
The Functional Dyspepsia Symptom Diary (FDSD) will be used to evaluate the dyspepsia symptoms of the patients
Patients with dyspepsia who have successfully eradicated Helicobacter pylori infection will be followed up for dyspepsia symptoms after 2 months and after 6 months to assess the remission of dyspepsia symptoms

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.
Shanghai Jiao Tong University School of Medicine

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 (Actual)

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.
March 11, 2024

Primary Completion (Estimated)

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.
May 31, 2025

Study Completion (Estimated)

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.
May 31, 2025

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).
May 14, 2024

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.
May 14, 2024

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.
May 20, 2024

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.
March 25, 2025

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.
December 26, 2024

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, 2024

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.
  • rjhy20240504

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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