Идёт набор NCT05121025

Pathogen-microbiome Interaction During Helicobacter Pylori Infection

— Наблюдательное Helicobacter 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: Analysis of gut microbiome and immune signatures.
Кому может быть актуально: Состояния в реестре: Helicobacter 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: Германия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Pathogen-microbiome Interaction in Human Response and Disease-outcome During Infection and Colonization With Helicobacter Pylori

Обзор

Helicobacter pylori affects the gut microbiome in ways that are only partially understood. In which patients H. pylori causes severe disease and in whom it merely colonizes, possibly even with beneficial effects, is not understood. The investigators are pursuing the hypothesis that changes in the gut microbiome that can be easily measured in stool have such predictive value.

Подробное описание

Helicobacter pylori colonizes the stomach of about half of the world's population, including about 20-30% of adults in Germany. In some cases, this colonization can lead to chronic inflammation of the gastric mucosa, which can lead to various serious diseases such as ulcer disease and gastric cancer. It has been reported several times in the literature that Helicobacter pylori infection negatively affects the human intestinal flora and can lead to microbial imbalance (dysbiosis). Recent studies, mostly from mouse models, reveal new roles and interactions of the microbiome: host immune response may influence bacterial activity; bacterial metabolites may determine microbiome functions. Differences in the microbiome were also found between Helicobacter pylori-infected patients and were associated with treatment success. On the other hand, beneficial microbial symbiosis may prevent intestinal inflammation. The reasons for these differences in the microbiome of Helicobacter pylori-infected patients, which may also contribute to treatment failure, remain to be investigated. Therefore, this project aims to investigate how Helicobacter pylori affects the bacteria and fungi of the human gastrointestinal microbiome and how the suspected microbial imbalance may influence treatment success. In this project, The investigators aim to answer the question of how these newly discovered mechanisms alter the course of human H. pylori infection. The investigators will analyze H. pylori itself in colonized patients and asymptomatic individuals (whole genome sequencing), determine the immune response of the carrier (RNA expression in lymphocytes), and composition of the gut microbiome (DNA sequencing) and activity (RNA expression in the bacteria/fungi and identification of metabolites). Using bioinformatics approaches, particularly machine learning, The investigators will determine the parameters that predict disease progression and eradication success. The results will provide important decision support for H. pylori-infected patients.

Вмешательства

Диагностический тест Analysis of gut microbiome and immune signatures
The investigators will analyse the microbiome composition (16S rDNA-sequencing and metagenomics), microbiome activity (RNA-sequencing of stool bacteria and metabolite sampling) and immune cell activity (leukocyte RNA-sequencing) of all study groups.

Первичные конечные точки

Helicobacter pylori microbiome and immune signatures [Срок оценки: 12-18 Months]

Вторичные конечные точки (1)

Helicobacter pylori eradication control [Срок оценки: 12-24 Months]

Критерии участия

Критерии включения

Patients: -

Male and female patients aged ≥ 18 years.
Specimens from patients undergoing tissue sampling, stool, and blood to rule out Helicobacter pylori infection
Written informed consent from patients.

Volunteer subjects: -

Male and female (non-pregnant) volunteers between the ages of 18-65 years.
Written informed consent from volunteers.
No acute medical conditions
No regular medication use, and no antibiotic use in the last 4 weeks.

Критерии исключения

Patients: -

Minor patients
Patients not capable of giving consent
Samples without sufficient residual material after standard diagnostic procedures
Samples from patients who have not given consent for testing

Volunteer subjects: -