Epidemiological Investigation of Helicobacter Pylori-infected Patients and the Effect of Eradication Treatment on Dyspepsia Symptoms
- Conditions
- Helicobacter Pylori InfectionDyspepsia
- Interventions
- Other: Epidemiological questionnaire and Functional Dyspepsia Symptom DiaryοΌFDSDοΌ
- Registration Number
- NCT06422052
- Lead Sponsor
- Shanghai Jiao Tong University School of Medicine
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2242
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Dyspepsia with Helicobacter pylori infection Epidemiological questionnaire and Functional Dyspepsia Symptom DiaryοΌFDSDοΌ -
- Primary Outcome Measures
Name Time Method Relief of Helicobacter pylori related dyspepsia 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
the incidence of dyspepsia in patients with Helicobacter pylori infection Time 0 when finished the Epidemiological questionnaire and Functional Dyspepsia Symptom Diary Proportion of patients with Helicobacter pylori infection with dyspeptic symptoms
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (26)
Chongqing Daping Hospital
π¨π³Chongqing, Chongqing, China
The Ninth People's Hospital of Chongqing
π¨π³Chongqing, Chongqing, China
The People's Hospital of Kaizhou District, CQ
π¨π³Chongqing, Chongqing, China
The First Affiliated Hospital of Xiamen University
π¨π³Xiamen, Fujian, China
The People's Hospital of Wuwei
π¨π³Wuwei, Gansu, China
The First People's Hospital of Qinzhou
π¨π³Qinzhou, Guangxi, China
The First Affiliated Hospital of Henan University of Science and Technology
π¨π³Luoyang, Henan, China
Yongcheng People's Hospital of Henan Province
π¨π³Shangqiu, Henan, China
Xuchang Central Hospital
π¨π³Xuchang, Henan, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
π¨π³Wuhan, Hubei, China
Baotou Central Hospital
π¨π³Baotou, Inner Mongolia, China
Dalian Friendship Hospital
π¨π³Dalian, Liaoning, China
The First Affiliated Hospital of Dalian Medical University
π¨π³Dalian, Liaoning, China
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
π¨π³Shanghai, Shanghai, China
Ruijin Hospital Luwan Branch
π¨π³Shanghai, Shanghai, China
Shanghai Construction Group Hospital
π¨π³Shanghai, Shanghai, China
Shanghai East Hospital
π¨π³Shanghai, Shanghai, China
Shanghai Putuo Liqun Hospital
π¨π³Shanghai, Shanghai, China
Shanghai Songjiang Central Hospital
π¨π³Shanghai, Shanghai, China
West China Fourth Hospital, Sichuan University
π¨π³Chengdu, Sichuan, China
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
π¨π³Tianjing, Tianjing, China
The Second People's Hospital of Kashgar, Xinjiang
π¨π³Kashgar, Xinjiang, China
Second People's Hospital of Jinning District, Kunming City
π¨π³Kunming, Yunnan, China
Ningbo Hangzhou Bay Hospital
π¨π³Ningbo, Zhejiang, China
The People's Hospital of Shengzhou
π¨π³Ningbo, Zhejiang, China
Shengzhou People's Hospital
π¨π³Shaoxing, Zhejiang, China