注册号: Registration number: |
ChiCTR2000032737 |
最近更新日期: Date of Last Refreshed on: |
2020-05-08 |
注册时间: Date of Registration: |
2020-05-08 |
注册号状态: |
预注册 |
Registration Status: |
Prospective registration |
注册题目: |
洗涤菌群移植治疗伴有疑似肠道菌群失调的2019新型冠状病毒肺炎(COVID-19)的临床研究 |
Public title: |
Clinical trial for the washed microbiota transplantation in the treatment of novel coronavirus pneumonia (COVID-19) patients suspected with gut microbiota dysbiosis |
注册题目简写: |
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English Acronym: |
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研究课题的正式科学名称: |
洗涤菌群移植治疗伴有疑似肠道菌群失调的2019新型冠状病毒肺炎(COVID-19)的临床研究 |
Scientific title: |
Clinical trial for the washed microbiota transplantation in the treatment of novel coronavirus pneumonia (COVID-19) patients suspected with gut microbiota dysbiosis |
研究课题代号(代码): Study subject ID: |
广东省教育厅普通高校新冠肺炎疫情防控专项研究项目(2020KZDZX1132) |
在二级注册机构或其它机构的注册号: The registration number of the Partner Registry or other register: |
申请注册联系人: |
叶志宁 |
研究负责人: |
吴礼浩 |
Applicant: |
Zhi-Ning Ye |
Study leader: |
Li-Hao Wu |
申请注册联系人电话: Applicant telephone: |
+86 15627862076 |
研究负责人电话: Study leader's telephone: |
+86 13660635861 |
申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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申请注册联系人电子邮件: Applicant E-mail: |
1554520250@qq.com |
研究负责人电子邮件: Study leader's E-mail: |
wulihao888@126.com |
申请单位网址(自愿提供): Applicant website(voluntary supply): |
研究负责人网址(自愿提供): Study leader's website(voluntary supply): |
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申请注册联系人通讯地址: |
广东省广州市越秀区农林下路19号 |
研究负责人通讯地址: |
广东省广州市越秀区农林下路19号 |
Applicant address: |
19 Nonglin Road Down, Guangzhou, Guangdong, China |
Study leader's address: |
19 Nonglin Road Down, Guangzhou, Guangdong, China |
申请注册联系人邮政编码: Applicant postcode: |
510080 |
研究负责人邮政编码: Study leader's postcode: |
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申请人所在单位: |
广东药科大学附属第一医院 |
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Applicant's institution: |
The First Affiliated Hospital of Guangdong Pharmaceutical University |
是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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伦理委员会批件文号: Approved No. of ethic committee: |
医伦审【2020】第(62)号 |
伦理委员会批件附件: Approved file of Ethical Committee: |
查看附件View |
批准本研究的伦理委员会名称: |
广东药科大学附属第一医院伦理委员会 |
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Name of the ethic committee: |
Ethics Committee of the First Affiliated Hospital of Guangdong Pharmaceutical University |
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伦理委员会批准日期: Date of approved by ethic committee: |
2020-05-08 | ||
伦理委员会联系人: |
张帆 |
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Contact Name of the ethic committee: |
Fan Zhang |
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伦理委员会联系地址: |
广东省广州市广东药科大学附属第一医院 |
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Contact Address of the ethic committee: |
The First Affiliated Hospital of Guangdong Pharmaceutical University, 19 Nonglin Road Down, Guangzhou, Guangdong, China |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
研究实施负责(组长)单位: |
广东药科大学附属第一医院;广州市第八人民医院 |
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Primary sponsor: |
The First Affiliated Hospital of Guangdong Pharmaceutical University; Guangzhou Eighth People's Hospital |
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研究实施负责(组长)单位地址: |
广东省广州市越秀区农林下路19号 |
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Primary sponsor's address: |
19 Nonglin Road Down, Guangzhou, Guangdong, China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
广东省教育厅普通高校新冠肺炎疫情防控专项研究项目(2020KZDZX1132) |
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Source(s) of funding: |
Special Research Project on Prevention and Control of COVID-19 in Universities of Guangdong Provincial Education Department (No. 2020KZDZX1132) |
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研究疾病: |
新型冠状病毒肺炎(COVID-19) |
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Target disease: |
Novel Coronavirus Pneumonia (COVID-19) |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
干预性研究 |
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Study type: |
Interventional study |
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研究所处阶段: |
探索性研究/预试验 | ||||||||||||||||||||||||||||||||||||||||||||
Study phase: |
0 |
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研究目的: |
分析洗涤菌群移植治疗伴有疑似肠道菌群失调的2019新型冠状病毒感染肺炎的疗效及安全性 |
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Objectives of Study: |
To explore the efficacy and safety of washed microbiota transplantation in COVID-19 patients suspected with gut microbiota dysbiosis |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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研究设计: |
随机平行对照 |
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Study design: |
Parallel |
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纳入标准: |
(1)确诊新型冠状病毒感染肺炎,且出现胃肠道症状; (2)确诊新型冠状病毒感染肺炎,且住院期间出现抗生素相关性腹泻。 |
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Inclusion criteria |
1. COVID-19 patients accompanied with gastrointestinal symptoms; 2. COVID-19 patients accompanied with antibiotic-associated diarrhea |
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排除标准: |
(1)新型冠状病毒肺炎危重型患者(参考《新型冠状病毒感染的肺炎诊疗方案(试行第七版)》); (2)胃肠道穿孔; (3)胃肠道梗阻; (4)近期肠瘘病史; (5)意识障碍(有误吸风险); (6)消化道出血; (7)合并有恶性肿瘤者; (8)不愿意参加本研究者。 |
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Exclusion criteria: |
(1) Critical type of COVID-19 according to COVID-19 diagnosis and treatment guidelines in China (7th edition); (2) Gastrointestinal perforation; (3) Gastrointestinal obstruction; (4) Recent history of intestinal fistula; (5) Disturbance of consciousness; (6) Gastrointestinal hemorrhage; (7) Malignant tumors; (8) Pregnant or lactating women. |
研究实施时间: Study execute time: |
从From2020-05-08至To 2021-06-08 |
征募观察对象时间: Recruiting time: |
从From2020-05-08至To 2021-05-08 |
干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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