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Clinical Trials in China / NCT06422052
Recruiting Observational

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

NCT06422052 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Jiao Tong University School of Medicine
Phase
Observational
Started
2024-03-11
Last updated
2024-12-30

Condition(s) studied

Helicobacter Pylori InfectionDyspepsia

Investigational drug(s) / intervention(s)

Epidemiological questionnaire and Functional Dyspepsia Symptom Diary（FDSD）

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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
  • 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

Trial sites (26)

FacilityCityRegionStatus
Chongqing Daping Hospital Chongqing Chongqing Municipality Recruiting
The Ninth People's Hospital of Chongqing Chongqing Chongqing Municipality Recruiting
The People's Hospital of Kaizhou District, CQ Chongqing Chongqing Municipality Recruiting
The First Affiliated Hospital of Xiamen University Xiamen Fujian Recruiting
The People's Hospital of Wuwei Wuwei Gansu Recruiting
The First People's Hospital of Qinzhou Qinzhou Guangxi Recruiting
The First Affiliated Hospital of Henan University of Science and Technology Luoyang Henan Recruiting
Yongcheng People's Hospital of Henan Province Shangqiu Henan Recruiting
Xuchang Central Hospital Xuchang Henan Recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei Recruiting
Baotou Central Hospital Baotou Inner Mongolia Recruiting
Dalian Friendship Hospital Dalian Liaoning Recruiting
The First Affiliated Hospital of Dalian Medical University Dalian Liaoning Recruiting
Renji Hospital, School of Medicine, Shanghai Jiao Tong University Shanghai Shanghai Municipality Recruiting
Ruijin Hospital Luwan Branch Shanghai Shanghai Municipality Recruiting
Shanghai Construction Group Hospital Shanghai Shanghai Municipality Recruiting
Shanghai East Hospital Shanghai Shanghai Municipality Recruiting
Shanghai Putuo Liqun Hospital Shanghai Shanghai Municipality Recruiting
Shanghai Songjiang Central Hospital Shanghai Shanghai Municipality Recruiting
West China Fourth Hospital, Sichuan University Chengdu Sichuan Recruiting
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine Tianjing Tianjing Recruiting
The Second People's Hospital of Kashgar, Xinjiang Kashgar Xinjiang Recruiting
Second People's Hospital of Jinning District, Kunming City Kunming Yunnan Recruiting
Ningbo Hangzhou Bay Hospital Ningbo Zhejiang Recruiting
The People's Hospital of Shengzhou Ningbo Zhejiang Recruiting
Shengzhou People's Hospital Shaoxing Zhejiang Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06422052 on ClinicalTrials.gov ↗ ← All trials in China