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临床试验/NCT05802732
NCT05802732招募中不适用

Diagnostic Accuracy Of Stool Antigen In Diagnosis Of Helicobacter Pylori Infection In Children

Assiut University1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
63
试验地点
1
主要终点
detect the diagnostic accuracy of stool Ag test in diagnosis of H.pylori infction in children and adolescents

研究概览

简要总结

Helicobacter pylori is among the most common bacterial infections in humans. Helicobacter pylori is a Gram-negative, S -shaped rod .The most likely mode of transmission is fecal-oral or oral-oral. Helicobacter pylori infection is acquired in early life and continues to have a high prevalence, especially in developing countries. Growing antibiotic-resistant strains necessitate adapted treatments. The majority of children with Helicobacter pylori infection remain asymptomatic, although a percentage of the infected children do develop Helicobacter. pylori-associated diseases. Helicobacter pylori is closely associated with the development of gastritis, gastric or duodenal ulcers. Helicobacter pylori infection can manifest with abdominal pain or vomiting and, less often, refractory iron deficiency anemia or growth retardation. Helicobacter pylori can be associated, though rarely, with chronic autoimmune thrombocytopenia. Anemia, idiopathic thrombocytopenic purpura, short stature, and sudden infant death syndrome (SIDS) have also been reported as possible extra-gastric manifestations of Helicobacter pylori infection . The diagnosis of Helicobacter pylori infection is made histologically by demonstrating the organism in the biopsy specimens. 13 C-urea breath tests and stool antigen tests are reliable noninvasive methods of detecting Helicobacter pylori infection in patients who do not require endoscopic evaluation. However, some guidelines recommend that non-invasive assessment methods are reserved to determine whether Helicobacter pylori has been eradicated not for diagnosis .However Helicobacter pylori-associated gastritis may, however, be an incidental histopathologic finding during upper endoscopy performed for unrelated indications such as the diagnosis of inflammatory bowel disease, or celiac disease.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

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

入选标准

  • Children and adolescents between 4 and 18 years old having chronic or reccurent unexplained dyspeptic symptoms (epigastric pain, post prandial fullness, early satiety, bleching, heart burn, bloating, flatulence, regurgitation, nausea, vomiting and/ or halitosis)(Miwa et al.,2012) and/ or non variceal hematemesis
  • The dyspeptic symptoms should be present at least 2months duration , which doesn't need to be consecutive, during the previous 6 months.(Rasquin et al., 2006)

排除标准

  • Patients who received anti sectertory drugs and/ or antibiotics in the previous 4 weeks before endoscopy.
  • Patients less than 4years and more than 18 years old.

结局指标

主要结局

detect the diagnostic accuracy of stool Ag test in diagnosis of H.pylori infction in children and adolescents

时间窗: over one year

Patients presented with chronic or recurrent unexplained dyspeptic symptoms and/or non variceal hematemesis will be submitted for stool antigen test

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

Yosra Alaa Abd El-baset Ali Khallaf

Principal Investigator

Assiut University

研究点 (1)

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