中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2600126830
最近更新日期： Date of Last Refreshed on：	2026-06-16 23:29:52
注册时间： Date of Registration：	2026-06-16 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	非肺部疾病人群的下呼吸道微生物组特征研究
Public title：	A Study on the Characteristics of Lower Respiratory Tract Microbiota in Non-Lung Disease Populations
注册题目简写：
English Acronym：
研究课题的正式科学名称：	非肺部疾病人群的下呼吸道微生物组特征研究
Scientific title：	A Study on the Characteristics of Lower Respiratory Tract Microbiota in Non-Lung Disease Populations
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：	刘嘉琳	研究负责人：	刘嘉琳
Applicant：	Jialin Liu	Study leader：	Jialin Liu
申请注册联系人电话： Applicant telephone：	+86 21 64370045	研究负责人电话： Study leader's telephone：	+86 21 63470045
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：	ljl11243@rjh.com.cn	研究负责人电子邮件： Study leader's E-mail：	ljl11243@rjh.com.cn
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：	上海市黄浦区瑞金二路197号6号楼4楼	研究负责人通讯地址：	上海市瑞金二路197号
Applicant address：	Floor 4, Building No. 6, No. 197 Ruijin Er Road, Huangpu District, Shanghai, China	Study leader's address：	Ruijin Hospital, 197 Rui Jin 2nd Road, Shanghai, 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：	上海交通大学医学院附属瑞金医院老年医学科
Applicant's institution：	Department of Geriatrics, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
研究负责人所在单位：	上海交通大学医学院附属瑞金医院
Affiliation of the Leader：	Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

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：	(2026)临伦审第(409)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：	上海交通大学医学院附属瑞金医院涉及人体的临床与科研项目伦理委员会
Name of the ethic committee：	Ruijin Hospital Ethics Committee, Shanghai JiaoTong University School of Medicine
伦理委员会批准日期： Date of approved by ethic committee：	2026-06-04 00:00:00
伦理委员会联系人：	赵彦琳
Contact Name of the ethic committee：	Zhao Yanlin
伦理委员会联系地址：	上海市瑞金二路197号
Contact Address of the ethic committee：	Ruijin Hospital, 197 Rui Jin 2nd Road, Shanghai, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 21 80585870	伦理委员会联系人邮箱： Contact email of the ethic committee：	zyl02d86@rjh.com.cn

研究实施负责（组长）单位：

上海交通大学医学院附属瑞金医院

Primary sponsor：

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

研究实施负责（组长）单位地址：

上海市瑞金二路197号

Primary sponsor's address：

Ruijin Hospital, 197 Rui Jin 2nd Road, Shanghai, 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)：	上海市	市(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	上海交通大学医学院附属瑞金医院	具体地址：	上海市瑞金二路197号
Institution hospital：	Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Address：	Ruijin Hospital, 197 Rui Jin 2nd Road, Shanghai, China

经费或物资来源：

国家自然科学基金

Source(s) of funding：

National Natural Science Foundation of China

研究疾病：

呼吸系统疾病其他科学问题

Target disease：

Other Scientific Questions in Respiratory Diseases

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

其它

Study phase：

N/A

研究设计：

队列研究

Study design：

Cohort study

研究目的：

主要研究目的：描绘无肺部疾病人群下呼吸道微生物组的物种组成、丰度分布及功能特征，建立非肺部疾病状态下的下呼吸道微生态参考图谱。次要研究目的：为后续各类呼吸系统疾病的微生态失调机制研究、早期预警标志物筛选及靶向干预策略研发提供数据支撑。

Objectives of Study：

Primary Objective: To characterize the species composition, abundance distribution, and functional attributes of the lower respiratory tract microbiota in individuals without pulmonary diseases, and to establish a reference atlas of the lower respiratory tract microbiome under non-lung disease conditions.Secondary Objective: To provide data support for subsequent investigations into the mechanisms of microbiota dysbiosis in various respiratory diseases, the screening of early warning biomarkers, and the development of targeted intervention strategies.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

1. The subject or their legally authorized representative provides signed and dated written informed consent, fully understands the study content, and voluntarily agrees to participate.
2. Age >= 18 years, regardless of gender.
3. Requires invasive mechanical ventilation (with mandatory indwelling endotracheal tube) under general anesthesia due to their own diagnostic or therapeutic needs, and the clinical procedures to be performed do not routinely require prophylactic antibiotic use according to clinical practice guidelines.
4. No history of acute or chronic pulmonary diseases (including but not limited to chronic obstructive pulmonary disease, bronchial asthma, lung cancer, interstitial lung disease, bronchiectasis, etc.) prior to or at enrollment, and no history of pulmonary infection within 30 days prior to enrollment. The following clinical features must be simultaneously met:
   (1) No evidence of pulmonary infiltrates, consolidation, cavities, or abnormal nodules (active or residual lesions) on pulmonary imaging (e.g., X-ray or CT);
   (2) No unexplained fever (body temperature > 38°C), with normal peripheral blood white blood cell (WBC) count;
   (3) No recent new-onset or worsening respiratory symptoms such as cough, sputum production, dyspnea, or tachypnea; no dry/moist rales or abnormal breath sounds on pulmonary auscultation; normal blood oxygen saturation/oxygenation indices prior to enrollment;
   (4) If respiratory pathogen testing is performed as part of routine diagnostic workup, results must be negative; if any pathogen test result is positive, the subject may only be enrolled after comprehensive evaluation by the investigator to rule out active infection.
5. Lower respiratory tract secretions can be collected within 24 hours following the initiation of invasive mechanical ventilation.
6. No receipt of systemic or topical medications that could significantly alter the baseline microbiota within 30 days prior to enrollment (see exclusion criteria for details).
7. Absence of diseases or conditions specified in the exclusion criteria, including immunodeficiencies.

排除标准：

1.确诊或疑似合并任何急、慢性肺部疾病（如肺部感染、慢性阻塞性肺疾病、支气管哮喘、间质性肺病、肺部原发/继发肿瘤、支气管扩张、活动性肺结核等）。
2.入组前30天内，曾接受过任何形式的呼吸道雾化吸入治疗者（包括但不限于雾化吸入糖皮质激素、抗菌药物、支气管扩张剂、祛痰药等）。
3.入组前30天内（含本次入院至采样前），曾因任何原因全身使用（口服或静脉途径）过任何剂量的抗细菌、抗真菌或抗病毒药物者。
4.入组前30天内，曾连续使用微生态调节制剂（如口服益生菌、益生元等）超过7天者。
5.存在免疫缺陷（如HIV感染、实体器官移植后、长期使用免疫抑制剂），或乙肝病毒（HBV）、丙肝病毒（HCV）活动期携带。
6.合并口腔、鼻咽部明确感染灶或近期口腔手术史。
7.气管插管过程存在明确误吸事件（如大量胃内容物反流吸入）。
8.妊娠期或哺乳期女性。
9.年龄<18周岁。
10.有严重精神疾病或无法配合研究程序者。
11.曾接受其他相关临床试验药物治疗，影响研究结果判读者。
12.拒绝或撤回本研究知情同意者。

Exclusion criteria：

1.Diagnosis or suspected presence of any acute or chronic pulmonary disease (e.g., pulmonary infection, chronic obstructive pulmonary disease, bronchial asthma, interstitial lung disease, primary/secondary lung tumors, bronchiectasis, active pulmonary tuberculosis, etc.).
2.Receipt of any form of inhaled nebulization therapy within 30 days prior to enrollment (including but not limited to nebulized inhaled corticosteroids, antibiotics, bronchodilators, mucolytics, etc.).
3.Systemic use (oral or intravenous) of any dose of antibacterial, antifungal, or antiviral agents for any reason within 30 days prior to enrollment (including during the current hospitalization up to the time of sampling).
4.Continuous use of microecological modulators (e.g., oral probiotics, prebiotics, etc.) for more than 7 days within 30 days prior to enrollment.
5.Presence of immunodeficiency (e.g., HIV infection, post-solid organ transplantation, long-term use of immunosuppressants), or active carrier status of hepatitis B virus (HBV) or hepatitis C virus (HCV).
6.Presence of a confirmed infectious focus in the oral cavity or nasopharynx, or a recent history of oral surgery.
7.A definite aspiration event during endotracheal intubation (e.g., massive reflux of gastric contents).
8.Pregnancy or breastfeeding.
9.Age < 18 years.
10.Severe mental illness or inability to comply with study procedures.
11.Prior receipt of other investigational drugs in related clinical trials that may interfere with the interpretation of study results.
12.Refusal or withdrawal of informed consent for this study.

研究实施时间：

Study execute time：

从 From 2026-06-08 00:00:00至 To 2029-05-30 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-06-16 00:00:00 至 To 2029-05-30 00:00:00

干预措施：

Interventions：

组别：	观察组	样本量：	60
Group：	Observation Group	Sample size：	60
干预措施：	无	干预措施代码：
Intervention：	None	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	上海市	市(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	上海交通大学医学院附属瑞金医院	单位级别：	三级甲等
Institution hospital：	Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	机械通气时间	指标类型：	次要指标
Outcome：	Mechanical ventilation duration	Type：	Secondary indicator
测量时间点：	从气管插管连接呼吸机开始有创通气至成功脱机拔管的时间	测量方法：	查询病史
Measure time point of outcome：	Time from intubation to successful extubation	Measure method：	Obtained from medical record review

指标中文名：	菌群结构及功能基因丰度	指标类型：	主要指标
Outcome：	Microbial community structure and functional gene abundance	Type：	Primary indicator
测量时间点：	插管后24小时内	测量方法：	16S rRNA基因测序，宏基因组学测序
Measure time point of outcome：	Within 24 hours after intubation	Measure method：	16S rRNA gene sequencing, metagenomic sequencing

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	下呼吸道分泌物	组织：
Sample Name：	Lower respiratory tract secretions	Tissue：
人体标本去向	使用后保存	说明
Fate of sample：	Preservation 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	岁 years
最大 Max age		岁 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）：

无

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

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：	无
Blinding：	None

是否共享原始数据： IPD sharing	否No
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）：	不共享
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Not applicable
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：	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）
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2026-06-16 23:29:28