ChiCTR2500104379 版本V1.0 版本创建时间2025/06/16 17:01:08 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2500104379 

最近更新日期：

Date of Last Refreshed on：

 2025-06-16 17:00:49 

注册时间：

Date of Registration：

 2025-06-16 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

志愿者生物样本采集临床研究

Public title：

Clinical Research on Biological Sample Collection by Volunteers

注册题目简写：

English Acronym：

研究课题的正式科学名称：

志愿者生物样本采集临床研究

Scientific title：

Clinical Research on Biological Sample Collection by Volunteers

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：

顾刘宝 

研究负责人：

顾刘宝 

Applicant：

Gu Liubao 

Study leader：

Gu Liubao 

申请注册联系人电话：

Applicant telephone：

 +86 152 6188 4799

研究负责人电话：

Study leader's
telephone：

+86 152 6188 4799

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：

 abobgu@126.com

研究负责人电子邮件：

Study leader's E-mail：

 abobgu@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：

南京市建邺区集庆门大街269号 江苏省省级机关医院（河西院区）

研究负责人通讯地址：

南京市珞珈路30号

Applicant address：

No. 269, Jichengmen Street, Jianye District, Nanjing City. Jiangsu Province Official Hospital

Study leader's address：

30 Luojia Road Nanjing

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：

江苏省省级机关医院

Applicant's institution：

Jiangsu Province Official Hospital

研究负责人所在单位：

江苏省省级机关医院

Affiliation of the Leader：

Jiangsu Province Official Hospital

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：

 2025037

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：

江苏省省级机关医院伦理审查委员会

Name of the ethic committee：

Provincial hospital Ethics Committee of Jiangsu Province

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-04-30 00:00:00

伦理委员会联系人：

黄健

Contact Name of the ethic committee：

无

伦理委员会联系地址：

南京市珞珈路30号

Contact Address of the ethic committee：

30 Luojia Road Nanjing

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 25 8969 9426

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 llwyhbgs@126.com

研究实施负责（组长）单位：

江苏省省级机关医院

Primary sponsor：

Jiangsu Province Official Hospital

研究实施负责（组长）单位地址：

南京市珞珈路30号

Primary sponsor's address：

30 Luojia Road Nanjing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

江苏省

市(区县)：

Country：

China

Province：

Jiangsu

City：

单位(医院)：

江苏省省级机关医院

具体地址：

南京市珞珈路30号

Institution
hospital：

Jiangsu Province Official Hospital

Address：

30 Luojia Road Nanjing

经费或物资来源：

志愿者生物样本采集临床研究/南京北极光生物科技有限公司

Source(s) of funding：

Nanjing Aurora Light Biotechnology Co., Ltd.

研究疾病：

无  

Target disease：

None

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：

 探索性研究/预试验 

Study phase：

0

研究设计：

横断面 

Study design：

Cross-sectional 

研究目的：

用于南京北极光生物科技有限公司承担的益生指标研究和功能菌株筛选及提取，为后续开发营养制剂和益生菌制剂提供理论基础及必要支持。  

Objectives of Study：

This research is mainly focused on the study of probiotic indicators and the screening, extraction of functional strains, undertaken by Nanjing Aurora Biotechnology Co., Ltd. It provides a theoretical basis and necessary support for the subsequent development of nutritional preparations and probiotic preparations.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.年龄18周岁~30周岁（含边界值），男女不限； (2)男性体重≥50 kg，女性体重≥45 kg，BMI：按体重指数=体重（kg）/身高^2（m^2）计算，在18.5-28范围内（含边界值）； (3)血常规、血生化、大便常规检查、病毒学检查（乙肝、丙肝、HIV、梅毒）在正常范围内或临床医生判断为“无临床意义”的异常； (4)经体格检查及生命体征检查，临床医生判断可参加本研究； (5)自愿作为志愿者，并签署知情同意书。 2.年龄65周岁~100周岁（含边界值），性别不限； (2)生活能够自理或基本自理； (3)经研究者判断的重要脏器的增龄性改变未导致明显的功能异常； (4)经研究者判断的影响健康的危险因素控制在与其年龄相适应的范围内营养状况良好； (5)自愿作为志愿者，并签署知情同意书； (6)试验研究前4周内未使用过益生菌及抗生素； (7)不符合上述条件任一者，不得作为志愿者入选。

Inclusion criteria

1. Age range: 18 to 30 years old (inclusive of boundary values), gender not restricted; (2) Male weight >= 50 kg, female weight >= 45 kg, BMI: calculated as weight (kg) / height^2 (m^2), within the range of 18.5 - 28 (inclusive of boundary values); (3) Blood routine, blood biochemistry, stool routine examination, and virological examination (hepatitis B, hepatitis C, HIV, syphilis) are within normal ranges or are judged by the clinical doctor as "without clinical significance" abnormalities; (4) After physical examination and vital sign examination, the clinical doctor determines that they can participate in this study; (5) Voluntarily as a volunteer and sign the informed consent form. 2. Age range: 65 years old to 100 years old (inclusive of boundary values), gender not restricted; (2) Able to take care of daily life or have basic self-care ability; (3) The age-related changes in important organs have not caused obvious functional abnormalities as judged by the researchers; (4) The risk factors affecting health have been controlled within the range appropriate for one's age, with good nutritional status; (5) Voluntary as a volunteer and have signed the informed consent form; (6) Within 4 weeks before the trial, no probiotics or antibiotics have been used; (7) Any of the above conditions not met, shall not be selected as a volunteer.

排除标准：

1.试验研究前3个月内大量失血（≥400 mL）或献血者（问诊）； (2)有晕血、晕针、贫血史者（问诊）； (3)试验研究前2周排便频次：平均每天排便多于3次，或超过3天排便一次（问诊）； (4)消化系统疾病患者,如慢性胃肠炎、活动期的或经治疗反复发作的胃及十二指肠溃疡、慢性胰腺炎、非特异性溃疡性结肠炎。胃肠息肉病、溃疡、肝硬化、恶性肿瘤消化系器质性疾病史。以及，有便血、便秘、腹胀、腹痛、腹泻、黄疸消化系统症状的（问诊）； (5)试验研究前1年内发生过急性泌尿道感染病者,急性肾盂肾炎病愈未满3个月者,泌尿系统结石发作期（问诊）； (6)过敏性疾病及反复发作过敏患者,如经常性荨麻疹、支气管哮喘、药物过敏（问诊）； (7)细菌性传染性疾病，各种结核病患者,如肺结核、肾结核、淋巴结核及骨结核；寄生虫病如血吸虫病、丝虫病患者。以及蛔虫病、蛲虫病感染未完全康复者（问诊）； (8)病毒学检查（乙肝、丙肝、HIV、梅毒）阳性或有临床意义的异常者； (9)试验研究前1个月内发生过经研究者判定有临床意义的短期严重感染，如重度感冒、水痘、新型冠状病毒感染（问诊）； (10)试验研究前4周内患过具有临床意义的疾病或接受过外科手术者（问诊）； (11)有任何临床严重疾病史或有心血管系统、内分泌系统、神经系统疾病或肺部、肝脏疾病，血液学、免疫学、精神病学疾病、代谢异常、家族遗传性疾病、恶性肿瘤病史者（问诊）； (12)不良生活习性：酗酒、嗜烟（问诊）； (13)试验研究前2周内服用过任何药物（包括中药）者或一个月内接种疫苗者（问诊）； (14)试验研究前3个月内参加了任何药物临床试验者（问诊）； (15)有痔疮活动性出血者和炎症性肠病； (16)研究者认为不适宜参加本研究的其它情况。
2.试验研究前3个月内大量失血（≥400 mL）（问诊）； (2)有晕血、晕针、贫血史者（问诊）； (3)试验研究前2周内患过具有接受过外科手术者（问诊）； (4)有任何临床严重疾病史或有严重心血管系统、神经系统疾病、血液学、免疫学、精神病学疾病、代谢异常、家族遗传性疾病、恶性肿瘤病史者（问诊）； (5)试验研究前半年内有药物滥用史（问诊）； (6)细菌性传染性疾病，各种结核病患者,如肺结核、肾结核、淋巴结核及骨结核；寄生虫病如血吸虫病、丝虫病患者。以及蛔虫病、蛲虫病感染未完全康复者（问诊）； (7)病毒学检查（乙肝、丙肝、HIV、梅毒）阳性或有临床意义的异常者； (8)有痔疮活动性出血者和炎症性肠病； (9)研究者认为不适宜参加本研究的其它情况。

Exclusion criteria：

1. Massive blood loss (>= 400 mL) within the previous 3 months or blood donors (interview); (2) Those with a history of fainting due to blood or needle injection, or anemia (interview); (3) Frequency of defecation within 2 weeks before the trial study: more than 3 times per day on average, or defecating once every 3 days (interview); (4) Patients with digestive system diseases, such as chronic gastroenteritis, active or repeatedly recurring gastric and duodenal ulcers, chronic pancreatitis, nonspecific ulcerative colitis. Gastrointestinal polyposis, ulcers, liver cirrhosis, malignant tumor diseases of the digestive system. As well as, digestive system symptoms such as hematochezia, constipation, abdominal distension, abdominal pain, diarrhea, jaundice (interview); (5) Those who have had acute urinary tract infections within the previous 1 year, those who have recovered from acute pyelonephritis within less than 3 months, those with urinary system stone attacks (interview); (6) Patients with allergic diseases and recurrent allergic reactions, such as frequent urticaria, bronchial asthma, drug allergies (interview); (7) Bacterial infectious diseases, patients with various tuberculosis diseases, such as pulmonary tuberculosis, renal tuberculosis, lymph node tuberculosis and bone tuberculosis; parasitic diseases such as schistosomiasis, filariasis patients. As well as patients with incomplete recovery from ascariasis, pinworm infection (interview); (8) Those with positive viral tests (hepatitis B, hepatitis C, HIV, syphilis) or abnormal results of clinical significance; (9) Those who have had short-term severe infections with clinical significance as determined by the researchers within the previous 1 month, such as severe colds, chickenpox, novel coronavirus infection (interview); (10) Those who have had clinically significant diseases or undergone surgical operations within 4 weeks before the trial study (interview); (11) Those with any severe clinical disease history or with diseases of the cardiovascular system, endocrine system, nervous system, or lung and liver, hematological, immunological, psychiatric diseases, metabolic abnormalities, family genetic diseases, malignant tumor history (interview); (12) Bad living habits: heavy drinking, heavy smoking (interview); (13) Those who have taken any medication (including traditional Chinese medicine) within 2 weeks before the trial study or received vaccinations within 1 month (interview); (14) Those who have participated in any drug clinical trials within the previous 3 months (interview); (15) Those with active bleeding from hemorrhoids and inflammatory bowel diseases; (16) Other situations that the researcher deems not suitable for participating in this study. 2. Massive blood loss within 3 months before the trial study (>= 400 mL) (interview); (2) Those with a history of fainting due to blood or needle, anemia (interview); (3) Those who had suffered from a disease requiring surgical treatment within 2 weeks before the trial study (interview); (4) Those with any serious clinical disease history or with severe cardiovascular, neurological diseases, hematological, immunological, psychiatric diseases, metabolic abnormalities, hereditary diseases, or malignant tumor history (interview); (5) Those who had a history of drug abuse within 6 months before the trial study (interview); (6) Bacterial infectious diseases, patients with various tuberculosis (such as pulmonary tuberculosis, renal tuberculosis, lymph node tuberculosis, and bone tuberculosis); parasitic diseases such as schistosomiasis, filariasis; and those with incomplete recovery from roundworm or pinworm infections (interview); (7) Those with positive viral tests (hepatitis B, hepatitis C, HIV, syphilis) or clinically significant abnormalities; (8) Those with active bleeding from hemorrhoids and inflammatory bowel diseases; (9) Other situations deemed unsuitable for participation in this study by the researcher. Those who have undergone surgical procedures (interview); (11) Those with any serious clinical disease history or with diseases in the cardiovascular, endocrine, nervous systems, or respiratory and liver organs, hematological, immunological, psychiatric diseases, metabolic abnormalities, hereditary diseases, or malignant tumor history (interview); (12) Bad lifestyle habits: heavy drinking, heavy smoking (interview); (13) Those who had taken any medication (including traditional Chinese medicine) within 2 weeks before the trial study or received vaccinations within 1 month (interview); (14) Those who participated in any drug clinical trials within 3 months before the trial study (interview); (15) Those with active bleeding from hemorrhoids and inflammatory bowel diseases; (16) Other situations deemed unsuitable for participation in this study by the researcher.

研究实施时间：

Study execute time：

从 From 2025-06-20 00:00:00至 To 2027-05-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-06-20 00:00:00 至 To 2027-05-31 00:00:00

干预措施：

Interventions：

组别：

中青年志愿者（男女）

样本量：

 200

Group：

Young volunteer group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

NA

Intervention code：

组别：

老年人组

样本量：

 100

Group：

Elderly group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

NA

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 江苏省 

市(区县)：

  

Country：

China

Province：

Jiangsu

City：

单位(医院)：

 江苏省省级机关医院 

单位级别：

 三级医院 

Institution
hospital：

Jiangsu Province Official Hospital

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

病史

指标类型：

主要指标

Outcome：

Medical history

Type：

Primary indicator

测量时间点：

筛选期间

测量方法：

(1) 病史：包括所有诊断的急性和慢性医疗状况以及既往病史等； (2) 生活方式评估（问卷调查）：包括饮食方式评估、运动状况评估、睡眠状况评估、生活方式评估； (3) 体格检查：一般情况（身高、体重等）、头部、颈部、胸部、肌肉骨骼、腹部、脊柱与四肢、神经系统、皮肤； (4) 生命体征：坐位血压、脉搏、体温； (5) 实验室检查： 血常规：血红蛋白、红细胞计数、WBC计数和血小板计数； 血生化：AS

Measure time point of outcome：

During the screening process

Measure method：

(1) Medical history: Includes all acute and chronic medical conditions diagnosed, as well as previous medical history, etc.; (2) Lifestyle assessment (questionnaire): Includes assessment of dietary habits, exercise status, sleep status, and lifestyle; (3) Physical examination: General condition (height, weight, etc.), head, neck, chest, musculoskeletal system, abdomen, spine and limbs, nervous system, skin; (4) Vital signs: Sitting blood pressure, pulse, body temperature; (5) Laboratory tests: B

指标中文名：

生活方式评估（问卷调查）

指标类型：

主要指标

Outcome：

Lifestyle assessment (questionnaire survey)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

体格检查

指标类型：

主要指标

Outcome：

Physical examination

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

生命体征

指标类型：

主要指标

Outcome：

Vital signs

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

实验室检查

指标类型：

主要指标

Outcome：

Laboratory tests

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 岁 years
最大 Max age 100 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）：

NA

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

NA

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：

病例记录表

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

Case Record Form，CRF

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-06-16 17:00:49