Mixed Strain H. Pylori Infection in Patients Who Have Problems With Eradication of H. Pylori
2010年7月16日 更新者：University Medical Centre Ljubljana
Multi Locus Sequence Typing (MLST) Used as Tool to Confirm Ability of Susceptible Helicobacter Pylori Strains to Gain Resistance to Clarithromycin During Eradication Therapy Independently of Mixed Strain Helicobacter Pylori Infection
The purpose of this study is to determine whether mixed H. pylori strain infection is the reason for eradication failure during treatment of H. pylori infection.
The investigators present the results got from extensive sampling of biopsy samples taken from individuals diagnosed with H. pylori connected disease.
The investigators were looking for individuals that were not able to eradicate H. pylori although they had susceptibility testing tailored antibiotic therapy.
On their control visit after 2 months they presented again with H. pylori although at their first visit they had H. pylori isolated from biopsy sample sensitive to all antibiotics prescribed.
Multi Locus Sequence Typing (MLST) was used to prove the sequence type of H. pylori and E test was used to determine susceptibility of H. pylori to antibiotics.
研究概览
地位
完全的
研究类型
观察性的
注册 (实际的)
10
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
-
Ljubljana、斯洛文尼亚、1000
- Institute of microbiology and immunology
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
The investigators invited people who were not able to eradicate H. pylori although at their first visit they had H. pylori sensitive to all antibiotics tested.
At first visit all patients had stomach biopsy sample taken and H. pylori isolated and therapy prescribed.
If they did not eradicate bacteria after 2 months they were again invited to control visit to define the problem and appropriate therapy prescribed.
They were again invitation to control visit at the end of June 2010 to see the outcome of therapy.
描述
Inclusion Criteria:
- People who have H. pylori sensitive to all antibiotics before therapy and and do not eradicate H. pylori after appropriate antibiotic therapy.
Exclusion Criteria:
- People who did not eradicate H. pylori because of primary resistance to antibiotics.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
H. pylori eradication failure
People who are not able to eradicate H. pylori although the appropriate antibiotic therapy taken.
|
Amoxicillin, metronidazole and tetracyclin as primary drugs to treat H. pylori infection in duration of 10 days.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Sequence type of H.pylori determined with MLST as a good evidence that people are infected with only one strain of H. pylori
大体时间：Six months after first visit the strains from before/after therapy will be inspected with MLST to see if people have mixed strain infection.
|
The investigators assume that people that are not able to eradicate infection with H. pylori although they have never been treated for such infection and they have taken appropriate therapy, have such problems because H. pylori is capable to escape from immune response.
The investigators will define if patients have the same H. pylori sequence type through longer period and that such H. pylori is capable to develope resistance to clarithromycin very quickly.Such patients can eliminate H. pylori if we check the infection status more often and give them more suitable antibiotic therapy.
|
Six months after first visit the strains from before/after therapy will be inspected with MLST to see if people have mixed strain infection.
|
|
Sequence type of H.pylori determined with MLST as a good evidence that people are infected with only one strain of H. pylori
大体时间：9 months after first visit to see if people still have H. pylori due to insufficient immune response.
|
The investigators assume that people that are not able to eradicate infection with H. pylori although they have never been treated for such infection and they have taken appropriate therapy, have such problems because H. pylori is capable to escape from immune response.
The investigators will define if patients have the same H. pylori sequence type through longer period and that such H. pylori is capable to develope resistance to clarithromycin very quickly.Such patients can eliminate H. pylori if we check the infection status more often and give them more suitable antibiotic therapy.
|
9 months after first visit to see if people still have H. pylori due to insufficient immune response.
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Alojz Ihan, MD. PhD、Institute of mircobiology and immunology, Slovenia
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2008年11月1日
初级完成 (实际的)
2009年12月1日
研究完成 (实际的)
2010年7月1日
研究注册日期
首次提交
2010年7月13日
首先提交符合 QC 标准的
2010年7月16日
首次发布 (估计)
2010年7月19日
研究记录更新
最后更新发布 (估计)
2010年7月19日
上次提交的符合 QC 标准的更新
2010年7月16日
最后验证
2010年7月1日
更多信息
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