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临床试验/NCT07128147
NCT07128147尚未招募不适用

Detection of Helicopacter Pylori in Patients With Metabolic Associated Fatty Liver Disease

Assiut University0 个研究点目标入组 200 人开始时间: 2026年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
主要终点
Prevalence of Helicobacter pylori infection in patients with Metabolic Associated Fatty Liver Disease as determined by Urea Breath Test

研究概览

简要总结

Owing to the correlation between H.pylori and MAFLD, our study aims to search for H.pylori in every patient with MAFLD to aid in the management of MAFLD and improve quality of life for these patients by decreaseing morbidity and mortality.

详细描述

Non-alcoholic fatty liver disease (NAFLD) has become increasingly common in recent years. NAFLD is considered the primary cause of chronic liver disorders and has emerged as a significant global public health concern.

The prevalence of NAFLD has been steadily rising due to changes in lifestyle and dietary habits, making it the most common chronic liver disease worldwide. The global prevalence of NAFLD is estimated at 30.1%.

Recently, researchers published an international expert consensus statement introducing a new definition: metabolic dysfunction-associated fatty liver disease (MAFLD), intended to replace the term non-alcoholic fatty liver disease (NAFLD).

The new nomenclature, MAFLD, is based on the presence of steatosis in more than 5% of hepatocytes, along with the absence of excessive alcohol consumption or other causes of chronic liver disease. A diagnosis of MAFLD can be established by the presence of hepatic steatosis in combination with one of the following three criteria: overweight/obesity, type 2 diabetes mellitus, or evidence of metabolic dysregulation.

Metabolic dysregulation is defined as having at least two of the following metabolic risk abnormalities: increased waist circumference, elevated blood pressure, dyslipidemia, prediabetes, insulin resistance, or elevated plasma C-reactive protein levels.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •All patients aged >18 years old.
  • •Was diagnosed as MAFLD based on abdominal ultrasonography (US) or other imaging techniques.

排除标准

  • •Patients aged ≤18 years old.
  • •Pregnancy.
  • •Presence of malignancy.
  • •Type I DM.
  • •Patients with fatty liver who undergone bariatric surgeries.
  • •Previous history of alcohol consumption, steroids, proton pump inhibitors, antibiotics, and contraceptive pills.

结局指标

主要结局

Prevalence of Helicobacter pylori infection in patients with Metabolic Associated Fatty Liver Disease as determined by Urea Breath Test

时间窗: Baseline (Day 1 of hospital admission)

H. pylori infection will be assessed at baseline using a standardized H.pylori antigen in stool. Results will be reported as the proportion (%) of patients with a positive test among all enrolled participants

Prevalence of Helicobacter pylori Infection in Patients with MAFLD

时间窗: At baseline (hospital admission)

Detection of H. pylori infection using \[stool antigen test /endoscopic biopsy\] in patients diagnosed with MAFLD

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amira Mohammed Abdel Mowgod

Lecturer, Tropical Medicine

Assiut University

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