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临床试验/NCT03310255
NCT03310255Unknown不适用

Helicobacter Pylori Infection in Renal Transplant Patients

Assiut University0 个研究点目标入组 86 人开始时间: 2017年11月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
86
主要终点
Detection of CagA & VacA Genotypes by PCR:

研究概览

简要总结

Upper gastrointestinal (GI) symptoms are frequent in organ transplant recipients. Peptic ulcers and related pathologies such as gastritis and duodenitis are known to occur with increased frequency (20-60%) and severity in renal transplant recipients. The frequency of severe complications is about 10% among transplant recipients and 10% of those might prove fatal As kidney transplant recipients have to take immunosuppressive drugs for a lifetime and because these drugs have many side effects that may not be differentiated from H. pylori infection Thus, in order to reduce the use of medications and subsequently to reduce the drug interactions ,proper detection and management of H pylori infection in those patients is preferred.

详细描述

The prevalence of HP colonization is about 30% in the United States and other developed countries as opposed to more than 80% in most developing countries.

Essentially, all HP-colonized persons have gastric inflammation, but this condition in itself is asymptomatic.

Upper gastrointestinal (GI) symptoms are frequent in organ transplant recipients. Peptic ulcers and related pathologies such as gastritis and duodenitis are known to occur with increased frequency (20-60%) and severity in renal transplant recipients. The frequency of severe complications is about 10% among transplant recipients and 10% of those might prove fatal.

GI complications might require dose reduction or the discontinuation of some of the immunosuppressive medications, affecting graft survival.

Considering the strong body of evidence supporting causal effects of HP infections on the development of peptic ulcers and gastric malignancies, the argumented rate of gastrointestinal complaints may bebattributed to increased HP infection rate among this population.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years.
  • Patients in the first 1st. year after kidney transplantation.
  • Patients diagnosed to have H.pylori infection by H.pylori fecal Ag will do endoscopy and biopsy.

排除标准

  • Patients who had previous upper endoscopy with evidence of gastritis or ulcers
  • Age more than 65 years old
  • Patients with any contraindications to upper endoscopy.

结局指标

主要结局

Detection of CagA & VacA Genotypes by PCR:

时间窗: 1 year

Amplified DNA will be analyzed by agarose gel electrophoresis. The positive sample will produce bands at DNA fragment 138-bp for CagA, 259/286-bp for VacA S1/S2, 290-bp and 352-bp for m1 \& m2, respectively.

Prevalence of H pylori post Renal Transplant Patients

时间窗: 1 year

Percentage of H pylori positive patients in post renal transplant patients

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

Mohamed Abdelmoniem Abdallah Mohamed

Principal Investigator at the department of Tropical medicine and gastroenterology

Assiut University

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