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Набор скоро начнётся NCT06425393

Intrafamilial Helicobacter Pylori Infection in Hong Kong

Без фазы С лечением H.Pylori Infection

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Urea beath test (UBT).
Кому может быть актуально
Состояния в реестре: H.Pylori Infection. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Prevalence and Risk Factors of Intrafamilial Helicobacter Pylori Infection in Hong Kong: a Prospective Cohort Study

Обзор

It is a single-centre, prospective cohort study, which will be conducted in a tertiary academic hospital. The study aims to investigate intrafamilial H. pylori infection status and to identify risk factors for H. pylori infection among household members. The rate of intrafamilial H. pylori spread in Hong Kong is currently unknown. It is also not clear whether the same risk factors for intrafamilial spread of H. pylori infection also apply in Hong Kong. In contrast to mainland China and Taiwan , recent consensus guideline on H. pylori management in Hong Kong in 2023 recommends against routine testing of asymptomatic household members or family members of H. pylori-infected adults. There is a knowledge gap on whether the family-based H. pylori screening is cost effective in our locality. Thus, the investigator aim to investigate infection status of household members of H. pylori infected individuals and risk factors for household infection in Hong Kong. The result from this study will shed light on the role of family-based screening and can inform future healthcare policy making on the strategy of H. pylori management and treatment in Hong Kong, ameliorating H. pylori infection-related disease and gastric cancer burden for society.

Подробное описание

Helicobacter pylori infects around half of the population in the world, and it is believed to affect more than half of population in Hong Kong. H. pylori infection is a well-known cause of chronic gastritis, peptic ulcer diseases and gastric cancer. Early detection and eradication of H. pylori infection is of utmost importance.

H. pylori infection is mainly transmitted by oral-oral, faecal-oral routes and water sources . Emerging studies demonstrated that intrafamilial spread is common. Recent national, family-based epidemiological study on H. pylori infection in mainland China showed a high familial infection rate ranging from 50.27% to 85.06%. In another study in central China, it was found that all family members were infected with H. pylori in 27.8% of the H. pylori infected households. Therefore, detection and eradication of H. pylori infection in family are very important to prevent development of H. pylori related diseases. Instead of the traditional strategies for individual-based management of H. pylori infection like 'test and treat' and 'screen and treat' strategies, a new strategy 'family- based H. pylori infection control and management' has been introduced. In 2021, China published a consensus report on the Family-based H. pylori infection control and management with an aim to reduce intrafamilial H. pylori spread in the Chinese population. In Taiwan, where the incidence of GC is high, a preventive strategy with 13C-urea breath test screening using the index case method and outreach the family members of the positive index cases. Eradication therapies for those who test positive and to follow up 2 years later to test the reinfection rate has been implemented to reduce the incidence of gastric cancers and reduce the cancer health inequality in indigenous communities.

Previous studies have identified several risk factors for intrafamilial transmission of H. pylori infection. Large family size of 3 or more in a household and living in highly infected areas in Northwest China were risk factors for household H. pylori infection while family members with higher income and education level , using serving spoons or chopsticks , drinking boiled water from tap source were associated with lower risk of household infection.

There is concern on the re-infection rate of H. pylori after eradication therapy. A systemic review revealed that global annual recurrence, reinfection and recrudescence rates of H. pylori were 4.3% (95%CI: 4-5), 3.1% (95%CI: 2-5) and 2.2% (95%CI: 1-3), respectively. An observational study in Turkey found that for H. pylori infected patients with whole family testing and eradication, the recurrence rate was 7.1% 9 months after treatment. On the other hand, when only the infected patient was eradicated but the whole family infection was not treated, the recurrence rate was 38.6% 9 months after treatment. These results suggest that treatment of the whole infected family is of great value in controlling H. pylori re-infection and preventing recurrence.

Вмешательства

  • Диагностический тест Urea beath test (UBT)
    H. pylori infection will be tested using a 13C-urea breath test Kit for all enrolled family members, following the manufacturer's instructions. The sensitivity and specificity of the assay are both over 95%, according to the manufacturer's introduction.

Первичные конечные точки

  • Rate of H. pylori infection in household members [Срок оценки: during the study period, 2 years]

Критерии участия

Критерии включения

  • Adults age>=18 years of age
  • For H. pylori infected patients only: Diagnosed to have H. pylori infection by either histology, rapid urease test or urea breath test
  • Written informed consent obtained

Критерии исключения

  • Unable to perform urea breath test
  • Contraindications for urea breath test
  • Used antibiotics within the past month/proton pump inhibitors within two weeks

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Диагностика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06425393 · 2024.143

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗