ChiCTR2600126856 版本V1.0 版本创建时间2026/06/17 14:26:49 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：

ChiCTR2600126856 

最近更新日期：

Date of Last Refreshed on：

2026-06-17 14:26:32 

注册时间：

Date of Registration：

2026-06-17 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

随机、双盲、安慰剂对照评价益生菌联合免疫检查点抑制剂、含铂双药治疗非小细胞肺癌的临床研究

Public title：

Randomized, double-blind, placebo-controlled clinical study evaluating the efficacy of probiotics combined with immune checkpoint inhibitors and platinum-based dual-drug therapy in the treatment of non-small cell lung cancer

注册题目简写：

English Acronym：

研究课题的正式科学名称：

随机、双盲、安慰剂对照评价益生菌联合免疫检查点抑制剂、含铂双药治疗非小细胞肺癌的临床研究

Scientific title：

Randomized, double-blind, placebo-controlled clinical study evaluating the efficacy of probiotics combined with immune checkpoint inhibitors and platinum-based dual-drug therapy in the treatment of non-small cell lung 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：

东丽 

研究负责人：

东丽 

Applicant：

Dong Li 

Study leader：

Dong Li 

申请注册联系人电话：

Applicant telephone：

+86 471 328 3322

研究负责人电话：

Study leader's telephone：

+86 471 328 3322

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：

dongli2126@126.com

研究负责人电子邮件：

Study leader's E-mail：

dongli2126@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：

内蒙古自治区呼和浩特市赛罕区昭乌达路20号

研究负责人通讯地址：

内蒙古自治区呼和浩特市赛罕区昭乌达路20号

Applicant address：

No. 20, Zhaowuda Road, Saihan District, Hohhot City, Inner Mongolia Autonomous Region

Study leader's address：

No. 20, Zhaowuda Road, Saihan District, Hohhot City, Inner Mongolia Autonomous Region

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：

内蒙古自治区人民医院

Applicant's institution：

Inner Mongolia People's hospital

研究负责人所在单位：

内蒙古自治区人民医院

Affiliation of the Leader：

Inner Mongolia People's hospital

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2021007

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：

内蒙古自治区人民医院伦理委员会

Name of the ethic committee：

Ethics Committee Inner Mongolia People's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2021-10-19 00:00:00

伦理委员会联系人：

张学森

Contact Name of the ethic committee：

Zhang Xuesen

伦理委员会联系地址：

内蒙古自治区呼和浩特市赛罕区昭乌达路20号

Contact Address of the ethic committee：

No. 20, Zhaowuda Road, Saihan District, Hohhot City, Inner Mongolia Autonomous Region

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 471 3283928

伦理委员会联系人邮箱：

Contact email of the ethic committee：

499631679@qq.com

研究实施负责（组长）单位：

内蒙古自治区人民医院

Primary sponsor：

Inner Mongolia People's hospital

研究实施负责（组长）单位地址：

内蒙古自治区呼和浩特市赛罕区昭乌达路20号

Primary sponsor's address：

No. 20, Zhaowuda Road, Saihan District, Hohhot City, Inner Mongolia Autonomous Region

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

内蒙古自治区

市(区县)：

Country：

China

Province：

Inner Mongolia Autonomous Region

City：

单位(医院)：

内蒙古自治区人民医院

具体地址：

内蒙古自治区呼和浩特市赛罕区昭乌达路20号

Institution
hospital：

Inner Mongolia People's hospital

Address：

No. 20, Zhaowuda Road, Saihan District, Hohhot City, Inner Mongolia Autonomous Region

经费或物资来源：

内蒙古自治区科技重大专项

Source(s) of funding：

Major Science and Technology Projects in Inner Mongolia Autonomous Region

Target disease：

Non-small cell lung cancer

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 II期临床试验 

Study phase：

2

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

招募晚期非小细胞肺癌患者，通过检测以下指标，探究给与益生菌干预能否增强患者免疫治疗联和含铂双药化疗的抗肿瘤效果。 1.临床观察：OS、PFS、ORR、DCR、DOR、KPS评分、毒性发生率或严重程度； 2.通过检测二胺氧化酶、D-乳酸、内毒素了解不同组NSCLC患者肠道黏膜屏障变化情况，分析益生菌干预对NSCLC癌患者肠道黏膜屏障功能的维护作用； 3.通过ELISA测定IL-17、TNF-α、IL-6、IL-8、TLR4、NF-Kβ等炎症因子水平，检测NSCLC患者的益生菌治疗组和观察组相关炎症因子的变化情况，评估炎症因子在益生菌治疗前后在NSCLC患者中的变化情况； 4.通过粪便菌群测序探究NSCLC患者肠道菌群特点，并对比不同时间的样品以解析益生菌对NSCLC患者肠道菌群的影响; 5.通过靶向代谢组测定患者粪便样品中短链脂肪酸、胆汁酸和氨基酸水平，并结合宏基因组测序深入探究益生菌辅助治疗NSCLC的可能机理。  

Objectives of Study：

Recruit patients with advanced non-small cell lung cancer and explore whether probiotics intervention can enhance the anti-tumor effect of immunotherapy combined with platinum based dual drug chemotherapy by testing the following indicators. 1. Clinical observation: OS, PFS, ORR, DCR, DOR, KPS score, incidence or severity of toxicity; 2. By detecting diamine oxidase, D-lactate, and endotoxin, we aim to understand the changes in intestinal mucosal barrier function in different groups of NSCLC patients, and analyze the maintenance effect of probiotic intervention on intestinal mucosal barrier function in NSCLC cancer patients; 3. Measure the levels of inflammatory factors such as IL-17, TNF - α, IL-6, IL-8, TLR4, NF-K β, etc. by ELISA, detect the changes in inflammatory factors related to the probiotic treatment group and observation group of NSCLC patients, and evaluate the changes in inflammatory factors in NSCLC patients before and after probiotic treatment; 4. Explore the characteristics of intestinal microbiota in NSCLC patients through fecal microbiota sequencing, and compare samples at different times to analyze the effect of probiotics on intestinal microbiota in NSCLC patients; 5. Determine the levels of short chain fatty acids, bile acids, and amino acids in patient fecal samples through targeted metabolomics analysis, and explore the possible mechanism of probiotic assisted treatment for NSCLC in depth by combining metagenomic sequencing.

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.受试者在研究开始≥18周岁，性别不限； 2.组织学或细胞学证实的NSCLC，并且为 III期不可手术或IV期肿瘤（按照国际肺癌研究协会(IASLC)胸部肿瘤分期手册第8版判断）的参与者； 3.基因检测EGFR（-），ALK（-）患者； 4.根据RECIST 1.1标准，受试者必须具有可测量的病灶； 5.ECOG评分至少为0分或者1分； 6.对于接受过任意次数的手术、介入治疗、化疗、放疗等系统性受试者必须符合以下所有入组标准，才具有进入本研究的资格：； 7.受试者既往未接受过针对晚期/转移性NSCLC的全身系统性化疗且未接受过免疫治疗； 8.预期生存期大于6个月； 9.重要器官的功能符合下列要求（首次使用研究用药前14天内不允许使用任何血液成分、细胞生长因子、升白药、升血小板药、纠正贫血药）： (1)中性粒细胞绝对计数（ANC）>=1.5×10^9/L； (2)血小板>=100×10^9/L； (3)血红蛋白>=9g/dL； (4)血清白蛋白>=2.8g/dL; (5)总胆红素<=1.5×ULN，ALT、AST和/或AKP<=2.5×ULN； (6)血清肌酐<=1.5×ULN或肌酐清除率大于60mL/min（Cockcroft-Gault，见附件二）； 10.同意并且有能力服用益生菌乳双歧杆菌V9（Kex02）固体饮料； 11.受试者需签署知情同意书； 12.受试者同意接受后续的医学影像检查以确定病灶进展，同意在服用益生菌乳双歧杆菌V9（Kex02）前后以及每次做回访时提供粪便样本； 13.育龄妇女必须在开始治疗前7天内行妊娠实验且结果为阴性，且愿意采取严格避孕措施，直至最后一次免疫检查点抑制剂后120天为止。

Inclusion criteria

1. Subjects must be 18 years old >= the start of the study, with any gender restrictions; 2. NSCLC confirmed by histologic or cytological studies, and participants with stage III unresectable or stage IV tumors (as determined by the International Association for the Study of Lung Cancer (IASLC) Thoracic Tumor Staging Manual, 8th edition); 3. Patients with genetic testing for EGFR(-) or ALK(-); 4. According to RECIST 1.1 criteria, subjects must have measurable lesions; 5. ECOG score of at least 0 or 1; 6. Subjects who have undergone any number of surgeries, interventional treatments, chemotherapy, radiotherapy, or other systemic treatments must meet all the following enrollment criteria to be eligible for this study: 7. Subjects who have never received systemic chemotherapy or immunotherapy for advanced/metastatic NSCLC; 8. Expected survival time greater than 6 months; 9. Vital organ function must meet the following requirements (no blood components, cell growth factors, white medicine, platelet-increasing drugs, or anemia correction drugs are allowed within 14 days before the first use of the investigational drug): (1) Absolute Neutrophil Count (ANC) > = 1.5×10^9/L; (2) Platelet > = 100×10^9/L; (3) hemoglobin > = 9 g/dL; (4) Serum albumin > = 2.8g/dL; (5) Total bilirubin < = 1.5× ULN, ALT, AST, and/or AKP < = 2.5× ULN; (6) Serum creatinine < = 1.5× ULN or creatinine clearance greater than 60 mL/min (Cockcroft-Gault, see Appendix 2); 10. Consent and ability to take a solid beverage containing the probiotic Bifidobacterium lactis V9 (Kex02); 11. Subjects must sign informed consent forms; 12. Subjects agreed to undergo follow-up medical imaging examinations to determine lesion progression and agreed to provide stool samples before and after taking the probiotic Bifidobacterium lactis V9 (Kex02) and at each follow-up; 13. Women of childbearing age must undergo a pregnancy test with a negative result within 7 days before starting treatment and be willing to use strict contraception until 120 days after the last immune checkpoint inhibitor.

排除标准：

1.怀孕、哺乳或未采取有效避孕措施的育龄女性（WOCBP），及与WOCBP有活跃性行为的未采取有效避孕措施的男性； 2.活动性中枢神经系统（CNS）转移的受试者； 3.受试者既往或同时患有其它恶性肿瘤（已治愈的皮肤基底细胞癌和宫颈原位癌除外）； 4.既往曾行免疫检查点抑制剂患者治疗不能入组；已知受试者既往对大分子蛋白制剂，或已知对任何免疫检查点抑制剂、或受试者对治疗期间应用的化疗用药成分过敏； 5.受试者存在任何活动性自身免疫病或有自身免疫病病史（如以下，但不局限于：自身免疫性肝炎、间质性肺炎，葡萄膜炎，肠炎，肝炎，垂体炎，血管炎，肾炎，甲状腺功能亢进，甲状腺功能降低，既往曾接受过甲状腺手术者不能纳入；受试者患有白癜风或在童年期哮喘已完全缓解，成人后无需任何干预的可纳入；受试者需要支气管扩张剂进行医学干预的哮喘则不能纳入）； 6.受试者正在使用免疫抑制剂、或全身、或可吸收的局部激素治疗以达到免疫抑制目的（剂量>10mg/天泼尼松或其他等疗效激素），并在入组前2周内仍在继续使用的； 7.伴有未控制的需要反复引流的胸腔积液、心包积液，或腹水的患者； 8.有未能良好控制的心脏临床症状或疾病，如：（1）NYHA2级以上心力衰竭（2）不稳定型心绞痛（3）1年内发生过心肌梗死（4）有临床意义的室上性或室性心律失常需要治疗或干预的患者； 9.凝血功能异常（PT>16s、APTT>43s、TT>21s、Fbg>2g/L），具有出血倾向或正在接受溶栓或抗凝治疗； 10.既往或目前有严重的出血（3个月内出血>30 ml）、咯血（4周内>5 ml的新鲜血液）或者12月内发生血栓栓塞事件（包括卒中事件和/或短暂性脑缺血发作）； 11.受试者有活动性感染或在筛选期间、首次给药前发生原因不明发热>38.5度（经研究者判断，受试者因肿瘤产生的发热可以入组）； 12.既往和目前有肺纤维化史、间质性肺炎、尘肺、放射性肺炎、药物相关肺炎、肺功能严重受损等的客观证据的患者； 13.受试者先天或后天免疫功能缺陷，如HIV感染者，或活动性肝炎（转氨酶不符合入选标准，乙肝参考： HBV DNA>=10^3/ml；丙肝参考： HCV RNA>=10^3/ml）；慢性乙型肝炎病毒携带者，HBV DNA＜2000 IU/ml（<10^4拷贝/ml），试验期间必须同时接受抗病毒治疗才可以入组； 14.受试者正在参加其他临床研究或距离前一项临床研究结束不足1个月；受试者在研究期间可能会接受其他全身抗肿瘤治疗； 15.研究用药前不足4周内或可能于研究期间接种活疫苗； 16.受试者已知有精神类药物滥用、酗酒或吸毒史； 17.研究者认为应排除在本研究之外，例如经研究者判断，受试者有其他可能导致本研究被迫中途终止的因素，如，其他的严重疾病（含精神疾病）需要合并治疗，有严重的实验室检查异常，伴有家庭或社会等因素，会影响到受试者的安全，或资料及样品的收集。

Exclusion criteria：

1. Women of childbearing potential (WOCBP) who are pregnant, breastfeeding, or not using effective contraception, and men who have active sexual activity with WOCBP and are not taking effective contraception; 2. Subjects with active central nervous system (CNS) metastases; 3. Subjects with a history of or concurrent other malignant tumors (except for cured basal cell carcinoma of the skin and cervical carcinoma in situ); 4. Subjects previously treated with immune checkpoint inhibitors cannot be enrolled; subjects with known prior allergies to large protein drugs, any immune checkpoint inhibitors, or components of chemotherapy drugs used during treatment; 5. Subjects with any active autoimmune disease or a history of autoimmune disease (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism—those who have had thyroid surgery cannot be included; subjects with vitiligo or childhood asthma fully resolved and requiring no intervention in adulthood can be included; subjects needing bronchodilator medical intervention for asthma cannot be included); 6. Subjects currently using immunosuppressants or systemic or absorbable local steroid treatments for immunosuppressive purposes (dose >10mg/day prednisone or equivalent steroid) and continuing use within 2 weeks before enrollment; 7. Patients with uncontrolled pleural or pericardial effusion, or ascites, requiring repeated drainage; 8. Subjects with poorly controlled cardiac symptoms or disease, such as: (1) NYHA class II or higher heart failure, (2) unstable angina, (3) myocardial infarction within the past year, (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; 9. Coagulation abnormalities (PT>16s, APTT>43s, TT>21s, Fbg>2g/L), bleeding tendencies, or receiving thrombolytic or anticoagulant therapy; 10. History or current severe bleeding (bleeding >30 ml within 3 months), hemoptysis (fresh blood >5 ml within 4 weeks), or thromboembolic events in the past 12 months (including stroke and/or transient ischemic attacks); 11. Subjects with active infections or unexplained fever >38.5°C during screening or before the first administration (fever caused by the tumor, as judged by the investigator, can be included); 12. Subjects with historical or current evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, or severely impaired lung function; 13. Subjects with congenital or acquired immune deficiencies, such as those infected with HIV, or with active hepatitis (transaminases not meeting the inclusion criteria, for hepatitis B: HBV DNA >=10^3/ml; for hepatitis C: HCV RNA ≥10^3/ml); chronic hepatitis B virus carriers with HBV DNA <2000 IU/ml (<10^4 copies/ml) must be on antiviral treatment during the study to be eligible. 14. Subjects currently participating in other clinical studies or less than 1 month since the end of a previous clinical study; subjects may receive other systemic anti-tumor treatments during the study; 15. Subjects who have received live vaccines within 4 weeks before the study medication or might receive them during the study; 16. Subjects with a known history of substance abuse, alcoholism, or drug addiction; 17. Subjects who the investigator believes should be excluded from this study, for example, if the investigator judges that the subject has other factors that could force the study to terminate early, such as other serious diseases (including mental illnesses) requiring combined treatment, severe laboratory abnormalities, or family/social factors that could affect the safety of the subject or the collection of data and samples.

研究实施时间：

Study execute time：

从 From 2021-10-19 00:00:00至 To 2024-01-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2021-10-23 00:00:00 至 To 2024-01-31 00:00:00  

干预措施：

Interventions：

组别：

对照组

样本量：

15

Group：

control group

Sample size：

干预措施：

安慰剂

干预措施代码：

Intervention：

placebo

Intervention code：

组别：

益生菌组

样本量：

15

Group：

probiotics group

Sample size：

干预措施：

动物双歧杆菌乳亚种V9（Kex02）

干预措施代码：

Intervention：

Bifidobacterium animalis subsp. lactis V9（Kex02）

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 内蒙古自治区 

市(区县)：

  

Country：

China 

Province：

Inner Mongolia Autonomous Region 

City：

 

单位(医院)：

内蒙古自治区人民医院 

单位级别：

三级甲等 

Institution
hospital：

Inner Mongolia People's hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

细胞因子

指标类型：

主要指标

Outcome：

cytokine

Type：

Primary indicator

测量时间点：

治疗4个周期结束后

测量方法：

收集各患者治疗4个周期结束后的血清，利用ELISA检测血清中的定IL-17A、TNF-α、IL-6、IL-8、IFN-γ的含量。

Measure time point of outcome：

After 4 cycles of treatment

Measure method：

Collect serum samples from each patient after 4 treatment cycles, and use ELISA to detect the levels of IL-17A, TNF-α, IL-6, IL-8, and IFN-γ in the serum.

指标中文名：

肠道粘膜屏障

指标类型：

主要指标

Outcome：

Intestinal mucosal barrier

Type：

Primary indicator

测量时间点：

治疗4个周期结束后

测量方法：

收集各患者治疗4个周期结束后的血清，利用ELISA检测血清中的D-乳酸、二胺氧化酶以及内毒素含量。

Measure time point of outcome：

After 4 cycles of treatment

Measure method：

Collect serum samples from each patient after 4 treatment cycles, and use ELISA to detect the levels of D-lactate, diamine oxidase, and endotoxin in the serum.

指标中文名：

微生物代谢产物

指标类型：

主要指标

Outcome：

Microbial metabolites

Type：

Primary indicator

测量时间点：

基线以及治疗4个周期结束后

测量方法：

收集各患者基线以及治疗4个周期结束后的血清，利用非靶向代谢组学技术检测患者在益生菌联合药物干预后的肠道菌群代谢特征

Measure time point of outcome：

Baseline and after 4 treatment cycles

Measure method：

Collect baseline and serum samples from each patient after 4 treatment cycles, and use non targeted metabolomics techniques to detect the gut microbiota metabolic characteristics of patients after probiotic combined drug intervention

指标中文名：

疾病控制率

指标类型：

次要指标

Outcome：

disease control rate

Type：

Secondary indicator

测量时间点：

治疗4个周期结束后

测量方法：

疾病控制率（DCR）为治疗后达到完全缓解（CR）、部分缓解（PR）及疾病稳定（SD）的受试者占总入组例数的比例。按预设随访周期，参照统一疾病评价标准判定疾病状态，统计符合CR、PR、SD的例数，计算其占比即为DCR。

Measure time point of outcome：

After 4 cycles of treatment

Measure method：

The disease control rate (DCR) is the proportion of subjects who achieve complete remission (CR), partial remission (PR), and disease stability (SD) after treatment to the total number of enrolled cases. According to the preset follow-up period, the disease status is determined based on the unified disease evaluation criteria, and the number of cases that meet CR, PR, and SD is counted. The proportion of cases that meet these criteria is calculated as DCR.

指标中文名：

肠道菌群

指标类型：

主要指标

Outcome：

gut microbiota

Type：

Primary indicator

测量时间点：

基线以及治疗4个周期结束后

测量方法：

收集各患者基线以及治疗4个周期结束后的粪便，利用宏基因组测序检测患者在益生菌联合药物干预后的肠道菌群特征

Measure time point of outcome：

Baseline and after 4 treatment cycles

Measure method：

Collect baseline and fecal samples from each patient after 4 treatment cycles, and use metagenomic sequencing to detect the gut microbiota characteristics of patients after probiotic combined drug intervention

指标中文名：

客观缓解率

指标类型：

次要指标

Outcome：

objective response rate

Type：

Secondary indicator

测量时间点：

治疗4个周期结束后

测量方法：

客观缓解率（ORR）为治疗后达到完全缓解（CR）及部分缓解（PR）的受试者占总入组例数的比例。按预设随访周期，参照统一疾病评价标准，由专业人员判定疾病状态，统计符合CR、PR的例数，计算其占比即为ORR。

Measure time point of outcome：

After 4 cycles of treatment

Measure method：

Objective response rate (ORR) is the proportion of subjects who achieved complete response (CR) and partial response (PR) after treatment to the total number of enrolled cases. According to the preset follow-up period and referring to the unified disease evaluation criteria, the disease status is determined by professionals, and the number of cases that meet CR and PR is counted to calculate their proportion as ORR.

指标中文名：

无进展生存期

指标类型：

主要指标

Outcome：

Progression-free survival

Type：

Primary indicator

测量时间点：

治疗4个周期结束后

测量方法：

无进展生存期（PFS）定义为从随机化入组至首次观察到疾病进展或任何原因死亡的时间，以先发生者为准。若受试者至随访截止日期未出现疾病进展且存活，则按截尾数据处理。疾病进展依据预设的影像学 / 临床评价标准判定，通过定期复查、影像学检查及临床随访记录进展情况，随访时间按月 / 天精确记录。

Measure time point of outcome：

After 4 cycles of treatment

Measure method：

Progression free survival (PFS) is defined as the time from randomization to the first observation of disease progression or death from any cause, whichever occurs first. If the subject has not experienced disease progression and is still alive by the follow-up deadline, the truncated data will be processed. Disease progression is determined based on predetermined imaging/clinical evaluation criteria, and progress is recorded through regular follow-up examinations, imaging examinations, and clin

指标中文名：

总生存期

指标类型：

主要指标

Outcome：

Overall Survival

Type：

Primary indicator

测量时间点：

治疗4个周期结束后

测量方法：

总生存期（Overall Survival, OS）定义为从随机化入组当日开始，至任何原因导致死亡的时间。若受试者至观察截止日期仍存活、失访或退出研究，则按截尾数据处理。随访时间按月或天为单位进行记录，通过门诊复查、电话随访等方式收集生存状态，确保随访完整准确。

Measure time point of outcome：

After 4 cycles of treatment

Measure method：

Overall survival (OS) is defined as the time from the day of randomization to death from any cause. If the subjects are still alive, lost to follow-up, or withdrawn from the study by the observation deadline, they will be treated as truncated data. Follow up time is recorded on a monthly or daily basis, and survival status is collected through outpatient follow-up, telephone follow-up, and other methods to ensure complete and accurate follow-up.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血清

组织：

Sample Name：

serum

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

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：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 80 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）：

随机数是使用Research Randomizer生成的，分组由一名独立的人员完成，该人员没有参与随后的试验实施、数据收集或结果评估。在研究期间，所有参与受试者招募人员都对小组分配保持未知。

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

Random numbers were generated using a Research Randomizer, and grouping was performed by an independent individual who did not participate in subsequent trial implementation, data collection, or outcome evaluation. During the study, all participants in the recruitment were kept unaware of the group allocation.

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：

对研究者和参试者设盲

Blinding：

Blinding for researchers and participants

是否共享原始数据：

IPD sharing

Yes

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）：

邮件联系研究者

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

Email the researcher

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：

CRF

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

CRF

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-06-17 14:26:32