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Clinical trial for the washed microbiota transplantation in the treatment of novel coronavirus pneumonia (COVID-19) patients suspected with gut microbiota dysbiosis
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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:

 

English Acronym:

 

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:

 

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):

 

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:

 

申请人所在单位:

广东药科大学附属第一医院 

Applicant's institution:

The First Affiliated Hospital of Guangdong Pharmaceutical University 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

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 

Name of the ethic committee:

Ethics Committee of the First Affiliated Hospital of Guangdong Pharmaceutical University 

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 

Contact Name of the ethic committee:

Fan Zhang 

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 

Contact Address of the ethic committee:

The First Affiliated Hospital of Guangdong Pharmaceutical University, 19 Nonglin Road Down, Guangzhou, Guangdong, China 

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 

Primary sponsor:

The First Affiliated Hospital of Guangdong Pharmaceutical University; Guangzhou Eighth People's Hospital 

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 

Primary sponsor's address:

19 Nonglin Road Down, Guangzhou, Guangdong, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

广东

市(区县):

广州

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

广东药科大学附属第一医院

具体地址:

广东省广州市越秀区农林下路19号

Institution
hospital:

The First Affiliated Hospital of Guangdong Pharmaceutical University

Address:

19 Nonglin Road Down

国家:

中国

省(直辖市):

广东

市(区县):

广州

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

广东省广州市第八人民医院

具体地址:

广东省广州市白云区华英路8号

Institution
hospital:

Guangzhou Eighth People's Hospital

Address:

8 Huayin Road, Baiyun District

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) 

Source(s) of funding:

Special Research Project on Prevention and Control of COVID-19 in Universities of Guangdong Provincial Education Department (No. 2020KZDZX1132) 

研究疾病:

新型冠状病毒肺炎(COVID-19) 

Target disease:

Novel Coronavirus Pneumonia (COVID-19) 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

探索性研究/预试验 

Study phase:

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 

Objectives of Study:

To explore the efficacy and safety of washed microbiota transplantation in COVID-19 patients suspected with gut microbiota dysbiosis 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

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。 

Inclusion criteria

1. COVID-19 patients accompanied with gastrointestinal symptoms; 2. COVID-19 patients accompanied with antibiotic-associated diarrhea 

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。 

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:

From2020-05-08To 2021-06-08 

征募观察对象时间:

Recruiting time:

From2020-05-08To 2021-05-08 

干预措施:

Interventions:

组别:

常规治疗组

样本量:

30

Group:

Routine treatment group

Sample size:

干预措施:

常规治疗

干预措施代码:

Intervention:

Routine treatment

Intervention code:

组别:

WMT治疗组

样本量:

30

Group:

WMT group

Sample size:

干预措施:

洗涤菌群移植

干预措施代码:

Intervention:

Washed microbiota transplantation

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

广东药科大学附属第一医院 

单位级别:

三甲医院 

Institution
hospital:

The First Affiliated Hospital of Guangdong Pharmaceutical University  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

广州市第八人民医院 

单位级别:

三甲医院 

Institution
hospital:

Guangzhou Eighth People's Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

新型冠状病毒核酸检测

指标类型:

主要指标 

Outcome:

SARS-Cov-2 nucleic acid test

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

空腹血糖

指标类型:

次要指标 

Outcome:

Fasting blood glucose

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肝功能

指标类型:

次要指标 

Outcome:

Liver function

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肾功能

指标类型:

次要指标 

Outcome:

Renal function

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

电解质

指标类型:

次要指标 

Outcome:

Electrolyte

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肌酶

指标类型:

次要指标 

Outcome:

Muscle enzyme

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肌红蛋白

指标类型:

次要指标 

Outcome:

Myoglobin

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

D二聚体

指标类型:

次要指标 

Outcome:

D-dimer

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血常规

指标类型:

次要指标 

Outcome:

Blood routine test

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

C-反应蛋白

指标类型:

次要指标 

Outcome:

C-reactive protein

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血沉

指标类型:

次要指标 

Outcome:

Erythrocyte sedimentation rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

降钙素原

指标类型:

次要指标 

Outcome:

Procalcitonin

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

白细胞介素-2

指标类型:

次要指标 

Outcome:

Interleukin-2

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

白细胞介素-6

指标类型:

次要指标 

Outcome:

Interleukin-6

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肿瘤坏死因子α

指标类型:

次要指标 

Outcome:

Tumor necrosis factor alpha

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

干扰素γ

指标类型:

次要指标 

Outcome:

Interferon gama

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

外周血淋巴细胞亚群

指标类型:

次要指标 

Outcome:

Lymphocyte subsets of peripheral blood

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肠道屏障功能检测

指标类型:

次要指标 

Outcome:

Intestinal barrier function test

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

氧合指数

指标类型:

次要指标 

Outcome:

Oxygenation index

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血气分析

指标类型:

次要指标 

Outcome:

Blood gas analysis

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肺炎严重指数

指标类型:

次要指标 

Outcome:

Pneumonia severity index

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

APACHE II评分

指标类型:

次要指标 

Outcome:

APACHE II score

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

Blood

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 65 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

采用区组随机化方法将入选患者分为常规治疗组和WMT组。以入院时间为配伍因素,将两名临近入院时间的患者作为一个区间。每个区间中的第一个患者将通过查询随机数表得到一个随机数,若随机数为奇数,则纳入常规治疗组,另一个患者纳入WMT组。

Randomization Procedure (please state who generates the random number sequence and by what method):

The enrolled patients will be allocated into routine treatment group and WMT group by the block randomization method. Taking the admission time as the compatibility factor, two patients adjacent to the admission time will be taken as a block group. The first patient in each block group will get a ra

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Within six months after the trial complete

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

试验完成6个月内公开,以数据记录表形式公开

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

The data will be publiced within 6 months of completion of the trial, in the form of a data record form

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

按数据记录表形式采集和管理

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Collection and management according to data record form

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2020-05-08
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