Clinical trial NCT06422052: Epidemiological Investigation of Helicobacter Pylori-infected Patients and the Effect of Eradication Treatment on Dyspepsia Symptoms
Official title: Epidemiological Investigation of Helicobacter Pylori-infected Patients and the Effect of Eradication Treatment on Dyspepsia Symptoms
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Helicobacter Pylori Infection
Dyspepsia
Keywords: Helicobacter Pylori Infection
Dyspepsia
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 2242
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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 outcomes:
measure: the incidence of dyspepsia in patients with Helicobacter pylori infection
timeFrame: Time 0 when finished the Epidemiological questionnaire and Functional Dyspepsia Symptom Diary
measure: Relief of Helicobacter pylori related dyspepsia
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chongqing Daping Hospital
state: Chongqing
city: Chongqing
country: China
facility: The Ninth People's Hospital of Chongqing
state: Chongqing
city: Chongqing
country: China
facility: The People's Hospital of Kaizhou District, CQ
state: Chongqing
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University
state: Fujian
city: Wuwei
country: China
facility: The People's Hospital of Wuwei
state: Gansu
city: Qinzhou
country: China
facility: The First People's Hospital of Qinzhou
state: Guangxi
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science and Technology
state: Henan
city: Shangqiu
country: China
facility: Yongcheng People's Hospital of Henan Province
state: Henan
city: Xuchang
country: China
facility: Xuchang Central Hospital
state: Henan
city: Wuhan
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
city: Baotou
country: China
facility: Baotou Central Hospital
state: Inner Mongolia
city: Dalian
country: China
facility: Dalian Friendship Hospital
state: Liaoning
city: Dalian
country: China
facility: The First Affiliated Hospital of Dalian Medical University
state: Liaoning
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
city: Shanghai
country: China
facility: Ruijin Hospital Luwan Branch
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Construction Group Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Putuo Liqun Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Songjiang Central Hospital
state: Shanghai
city: Chengdu
country: China
facility: West China Fourth Hospital, Sichuan University
state: Sichuan
city: Tianjing
country: China
facility: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
state: Tianjing
city: Kashgar
country: China
facility: The Second People's Hospital of Kashgar, Xinjiang
state: Xinjiang
city: Kunming
country: China
facility: Second People's Hospital of Jinning District, Kunming City
state: Yunnan
city: Ningbo
country: China
facility: Ningbo Hangzhou Bay Hospital
state: Zhejiang
city: Ningbo
country: China
facility: The People's Hospital of Shengzhou
state: Zhejiang
city: Shaoxing
country: China
facility: Shengzhou People's Hospital
state: Zhejiang
Study officials:
References: