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临床试验/NCT07704255
NCT07704255招募中4 期

Study on the Effect of Fecal Microbiota Transplantation on Eradication of Refractory Helicobacter Pylori Infection

Sichuan Provincial People's Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2026年7月20日最近更新:
适应症

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
10
试验地点
1
主要终点
Whether Hp is successfully eradicated

研究概览

简要总结

To determine whether regulating the gut microbiota can contribute to the eradication of refractory H. pylori infection.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1. Ages 18-70
  • 2. Hp infection treatment failed ≥4 times with guidelines-recommended therapies
  • 3. Patients with early gastric cancer, peptic ulcer, gastric MALT lymphoma, atrophic gastritis and other diseases requiring the eradication of Hp.

排除标准

  • 1. Antibiotics and bismuth were taken within 4 weeks before this treatment; Or had taken PPI, H2 receptor antagonist, P-CAB within 2 weeks prior to treatment;
  • 2. Pregnant or lactating women;
  • 3. Those who are allergic to the investigational drugs used in this test or have contraindications;
  • 4. Participated in other drug trials within 3 months before the treatment of this trial;
  • 5. There are other serious diseases that affect the evaluation of this study at the same time, or they cannot correctly express their own complaints and cannot cooperate;
  • 6. Subjects with dysphagia;
  • 7. Patients with malignant tumors, serious concomitant diseases, severe ulcer bleeding or perforation;
  • 8. Patients judged by the investigator to be unsuitable for clinical trials.
  • 9. Those who do not want to sign the informed consent for the study.

结局指标

主要结局

Whether Hp is successfully eradicated

时间窗: 2years

The successful eradication of Hp was determined by 13C urea breath test, immunohistochemical staining of Hp and Hp culture.test, immunohistochemical staining of gastric mucosa and Hp culture

次要结局

未报告次要终点

研究者

发起方
Sichuan Provincial People's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gao Caiping

Chief physician

Sichuan Provincial People's Hospital

研究点 (1)

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