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胃癌术后口服益生菌复配制剂对术后恢复的影响
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注册号:

Registration number:

ChiCTR1900022506 

最近更新日期:

Date of Last Refreshed on:

2019-04-14 

注册时间:

Date of Registration:

2019-04-14 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

胃癌术后口服益生菌复配制剂对术后恢复的影响 

Public title:

Effect of oral probiotic compound preparation for postoperative recovery of gastric cancer 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

胃癌术后口服益生菌复配制剂对术后恢复的影响 

Scientific title:

Effect of oral probiotic compound preparation for postoperative recovery of gastric cancer 

研究课题代号(代码):

Study subject ID:

 

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:

邓小荣 

研究负责人:

邓小荣 

Applicant:

Deng xiaorong 

Study leader:

Deng xiaorong 

申请注册联系人电话:

Applicant telephone:

+86 13870889003 

研究负责人电话:

Study leader's telephone:

+86 13870889003 

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:

dengxr77@163.com 

研究负责人电子邮件:

Study leader's E-mail:

dengxr77@163.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:

中国江西南昌市民德路1号 

研究负责人通讯地址:

中国江西南昌市民德路1号 

Applicant address:

1 Mingde Road, Nanchang, Jiangxi, China 

Study leader's address:

1 Mingde Road, Nanchang, Jiangxi, China 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

南昌大学第二附属医院 

Applicant's institution:

Second Affiliated Hospital of Nanchang 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:

201801 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

南昌大学第二附属医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of the Second Affiliated Hospital of Nanchang University 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-09-26 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

南昌大学第二附属医院 

Primary sponsor:

Second Affiliated Hospital of Nanchang University 

研究实施负责(组长)单位地址:

江西省南昌市民德路1号 

Primary sponsor's address:

1 Mingde Road, Nanchang, Jiangxi, 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):

江西

市(区县):

南昌

Country:

China

Province:

Jiangxi

City:

单位(医院):

南昌大学第二附属医院

具体地址:

江西省南昌市民德路1号

Institution
hospital:

Second Affiliated Hospital of Nanchang University

Address:

1 Mingde Road, Nanchang, Jiangxi Province

经费或物资来源:

自筹 

Source(s) of funding:

raise independently 

研究疾病:

胃癌 

Target disease:

gastric cancer 

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:

其它 

Study phase:

N/A 

研究目的:

通过口服益生菌恢复胃癌胃切除术后导致的胃肠道功能失常,帮助恢复肠道微生物多样性,增加优势菌群浓度,预防或缓解胃癌术后并发症,恢复胃肠道功能。 

Objectives of Study:

By oral probiotics, gastrointestinal dysfunction caused by gastrectomy for gastric cancer can be restored, the diversity of intestinal microorganisms can be restored, the concentration of dominant bacteria can be increased, the complications after gastrectomy for gastric cancer can be prevented or alleviated, and the gastrointestinal function can be restored. 

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、知情同意者; 2、病理确诊为胃癌; 3、患者一般情况良好,年龄18-70岁。 

Inclusion criteria

1. Informed consent; 2. Pathological diagnosis of gastric cancer; 3. Patients are generally in good condition, aged 18-70 years. 

排除标准:

1、患者合并有严重的心、肺、肾、肝功能障碍及代谢性疾病; 2、发现远处转移; 3、对益生菌过敏者; 4、术前不伴有严重的并发症,未接受过放、化疗。 5、有免疫疾病、不能口服或吸收消化道药物或对益生菌过敏者。 

Exclusion criteria:

1. Patients with severe heart, lung, kidney, liver dysfunction and metabolic diseases; 2. Discovery of distant metastasis; 3. Allergies to probiotics; 4. No serious complications before surgery, no radiation or chemotherapy. 5. Those who have immune diseases, cannot take orally or absorb digestive tract drugs or are allergic to probiotics. 

研究实施时间:

Study execute time:

From2019-06-01To 2020-06-01 

干预措施:

Interventions:

组别:

试验组

样本量:

20

Group:

Experimental group

Sample size:

干预措施:

口服益生菌复配制剂

干预措施代码:

Intervention:

Oral probiotic compound preparation

Intervention code:

组别:

对照组

样本量:

20

Group:

Control group

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

Placebo

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江西 

市(区县):

 

Country:

China 

Province:

Jiangxi 

City:

 

单位(医院):

南昌大学第二附属医院 

单位级别:

三甲 

Institution
hospital:

Second Affiliated Hospital of Nanchang University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

粪便高通量测序

指标类型:

主要指标 

Outcome:

High throughput sequencing of feces

Type:

Primary 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:

粪便

组织:

Sample Name:

feces

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 70 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):

本研究为一项单盲、随机、对照、单中心研究。

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

This study is a single-blind, randomized, controlled, single-center study.

盲法:

未说明

Blinding:

Not stated

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/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):

NCBI

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

NCBI

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:

电子采集和管理系统

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

Electronic Data Capture, EDC

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-04-14
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