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临床试验/TCTR20190127003
TCTR20190127003招募中未知

Effectiveness of 7-day and 14-day high-dose PPI bismuth-containing quadruple therapy with probiotics supplement for Helicobacter pylori eradication: A double blinded-randomized placebo-controlled study

Thammasat University0 个研究点目标入组 100 人开始时间: 2019年1月27日最近更新:
适应症

试验速览

阶段
未知
状态
招募中
入组人数
100

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 Years 至 80 Years(—)
性别
All

入选标准

  • 1.Having abdominal pain which was indicative for assessing with esophagogastroduodenoscopy consistent with The Gastroenterological Association of Thailand(12) as followed;
  • •Coexisting with dysphagia
  • •Evidence of gastrointestinal blood loss such as previous history of bloody vomiting, melena and iron deficiency anemia
  • •Unexplained weight loss such as unintended weight losing, recent diagnosis of diabetes mellitus or thyrotoxicosis
  • •Persistent vomiting
  • •Age onset of symptoms > 50 years old without any explainable causes including drugs and food
  • •Progressive or recurrent symptoms after adequate medical treatments
  • 2.Detecting for H. pylori infection with positive urease test and/or pathological findings of H. pylori and/or positive cultures
  • 3.Having written informed consent for all participants.

排除标准

  • 1.Any cases with upper gastrointestinal bleeding
  • 2.Being treated with medications affecting the research outcome, for example, by using antibiotics including amoxicillin, clarithromycin, tetracycline or metronidazole within 1 month before the enrollment
  • 3.Having contraindication to gastric biopsy such as coagulopathy
  • 4.Any history of drug allergy for Tetracycline, Metronidazole, Bismuth, and Dexlansoprazole
  • 5.Receiving proton pump inhibitor or receiving any antibiotics or bismuth within 4 weeks or consumption of probiotic products within 2 weeks.
  • 6.Being pregnant or raising children with breast-feeding
  • 7.Having history of H. pylori eradication treatment
  • 8.Having severe underlying disease including end-stage renal disease requiring hemodialysis or peritoneal dialysis (GFR < 15), cirrhosis with Child-Pugh classification grade C, immunocompromised host with AIDS, malignancy and/or bed ridden cerebrovascular disease.
  • 9.Any cases who receiving anticoagulant
  • 10.Having previous gastric surgery
  • 11.Unwilling to participate into research
  • 12.Having history of taking previous medications which interacted with the research treatment
  • 13.Having a medication that causes drugs to drugs interaction with a research medication

研究者

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