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

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)

Facility	City	Region	Status
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