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

Обзор

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.

Вмешательства

• Другое 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.

Первичные конечные точки

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 26 центров

• Chongqing Daping Hospital — Чунцин
• The Ninth People's Hospital of Chongqing — Чунцин
• The People's Hospital of Kaizhou District, CQ — Чунцин
• 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
• … и ещё 18 центров

Идентификаторы

NCT: NCT06422052 · rjhy20240504

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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