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

Shanghai Jiao Tong University School of Medicine

Status: Enrolling

Conditions: Helicobacter Pylori Infection; Dyspepsia

Treatments: Other: Epidemiological questionnaire and Functional Dyspepsia Symptom Diary（FDSD）

Study type: Observational

Funder types: Other

Identifiers

NCT06422052

rjhy20240504

Details and patient eligibility

About

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.

Enrollment: 2,242 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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.

Trial design

2,242 participants in 1 patient group

Dyspepsia with Helicobacter pylori infection

Treatment:

Other: Epidemiological questionnaire and Functional Dyspepsia Symptom Diary（FDSD）