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Recruiting NCT06422052

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

— Observational Helicobacter Pylori Infection Dyspepsia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Epidemiological questionnaire and Functional Dyspepsia Symptom Diary（FDSD）.
Who it may be relevant to
Registry conditions: Helicobacter Pylori Infection, Dyspepsia. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • the incidence of dyspepsia in patients with Helicobacter pylori infection [Time frame: Time 0 when finished the Epidemiological questionnaire and Functional Dyspepsia Symptom Diary]
  • Relief of Helicobacter pylori related dyspepsia [Time frame: 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]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 26 centers
  • Chongqing Daping Hospital — Chongqing
  • The Ninth People's Hospital of Chongqing — Chongqing
  • The People's Hospital of Kaizhou District, CQ — Chongqing
  • The First Affiliated Hospital of Xiamen University — Xiamen
  • The People's Hospital of Wuwei — Wuwei
  • The First People's Hospital of Qinzhou — Qinzhou
  • The First Affiliated Hospital of Henan University of Science and Technology — Luoyang
  • Yongcheng People's Hospital of Henan Province — Shangqiu
  • … and 18 more centers

Identifiers

NCT: NCT06422052 · rjhy20240504

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗