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

Recruiting

• Conditions: Helicobacter Pylori Infection; Dyspepsia

• 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

Study Timeline

• Study Start: 2024-03-11
• Study First Submitted: 2024-05-14
• Study First Submitted QC: 2024-05-14
• Study First Posted: 2024-05-20
• Status Verified: 2024-11
• Last Update Submitted: 2024-12-26
• Last Update Posted: 2024-12-30
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2242

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

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

Trial Locations

Locations (26)

Chongqing Daping Hospital; 🇨🇳 Chongqing, Chongqing, China

The Ninth People's Hospital of Chongqing; 🇨🇳 Chongqing, Chongqing, China

The People's Hospital of Kaizhou District, CQ; 🇨🇳 Chongqing, Chongqing, China

The First Affiliated Hospital of Xiamen University; 🇨🇳 Xiamen, Fujian, China

The People's Hospital of Wuwei; 🇨🇳 Wuwei, Gansu, China

The First People's Hospital of Qinzhou; 🇨🇳 Qinzhou, Guangxi, China

The First Affiliated Hospital of Henan University of Science and Technology; 🇨🇳 Luoyang, Henan, China

Yongcheng People's Hospital of Henan Province; 🇨🇳 Shangqiu, Henan, China

Xuchang Central Hospital; 🇨🇳 Xuchang, Henan, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China

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