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

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: Recruiting
• Conditions: Dyspepsia; Helicobacter Pylori Infection
• Intervention / Treatment: Other: Epidemiological questionnaire and Functional Dyspepsia Symptom Diary（FDSD）

• Study Type: Observational
• Enrollment (Estimated): 2242

Contacts and Locations

• Study Contact: Name: Hong Lu, MD; Phone Number: +8613611958022; Email: hlu@sjtu.edu.cn

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China
      • Recruiting
      • The People's Hospital of Kaizhou District, CQ
      • Contact: Qiang Wu; Phone Number: +8618223960853
  • 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
  • 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
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Recruiting
      • Renji Hospital, School of Medicine, Shanghai Jiao Tong University
      • Contact: Hong Lu, MD; Phone Number: +8613611958022; Email: hlu@sjtu.edu.cn
    • Shanghai, Shanghai, China
      • Recruiting
      • Shanghai Construction Group Hospital
      • Contact: Qi Liao; Phone Number: +8613512128067
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • West China Fourth Hospital, Sichuan University
      • Contact: Yan Ou; Phone Number: +8615008228212
  • Xinjiang
    • Kashgar, Xinjiang, China
      • Recruiting
      • The Second People's Hospital of Kashgar, Xinjiang
      • Contact: Jilin Wang; Phone Number: +8613761853016; Email: wangjilin811123@163.com
  • 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

Participation Criteria

Eligibility Criteria

• 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 15-80 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
the incidence of dyspepsia in patients with Helicobacter pylori infection	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	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

• Sponsor: Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2024
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: May 14, 2024
• First Submitted That Met QC Criteria: May 14, 2024
• First Posted (Actual): May 20, 2024

Study Record Updates

• Last Update Posted (Actual): May 20, 2024
• Last Update Submitted That Met QC Criteria: May 14, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Dyspepsia; Helicobacter Pylori Infection
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Dyspepsia
• Other Study ID 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