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

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06422052
• Other study ID #: rjhy20240504
• Status: Recruiting
• Start date: March 11, 2024
• Est. completion date: May 31, 2025

Study information

• Verified date: May 2024
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Hong Lu, MD
• Phone: +8613611958022
• Email: hlu[@]sjtu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2242
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Male or female patients aged 15-80 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.

Related Conditions & MeSH terms

• Dyspepsia
• Helicobacter Pylori Infection

Intervention

Other:
• 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.

Locations

Country	Name	City	State
China	Baotou Central Hospital	Baotou	Inner Mongolia
China	West China Fourth Hospital, Sichuan University	Chengdu	Sichuan
China	The People's Hospital of Kaizhou District, CQ	Chongqing	Chongqing
China	The First Affiliated Hospital of Dalian Medical University	Dalian	Liaoning
China	The Second People's Hospital of Kashgar, Xinjiang	Kashgar	Xinjiang
China	Second People's Hospital of Jinning District, Kunming City	Kunming	Yunnan
China	Ningbo Hangzhou Bay Hospital	Ningbo	Zhejiang
China	The People's Hospital of Shengzhou	Ningbo	Zhejiang
China	The First People's Hospital of Qinzhou	Qinzhou	Guangxi
China	Renji Hospital, School of Medicine, Shanghai Jiao Tong University	Shanghai	Shanghai
China	Shanghai Construction Group Hospital	Shanghai	Shanghai
China	The People's Hospital of Wuwei	Wuwei	Gansu
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of dyspepsia in patients with Helicobacter pylori infection	Proportion of patients with Helicobacter pylori infection with dyspeptic symptoms	Time 0 when finished the Epidemiological questionnaire and Functional Dyspepsia Symptom Diary
Primary	Relief of Helicobacter pylori related dyspepsia	The Functional Dyspepsia Symptom Diary (FDSD) will be used to evaluate the dyspepsia symptoms of the patients	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