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：	ChiCTR2400080793
最近更新日期： Date of Last Refreshed on：	2024-02-07 15:00:38
注册时间： Date of Registration：	2024-02-07 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	后生素联合免疫检查点抑制剂提高广泛期小细胞肺癌治疗效果的临床研究
Public title：	Clinical study on improving the therapeutic effect of postbiotics combined with immune checkpoint inhibitors in extensive-stage small cell lung cancer
注册题目简写：
English Acronym：
研究课题的正式科学名称：	后生素联合免疫检查点抑制剂提高广泛期小细胞肺癌治疗效果的临床研究
Scientific title：	Clinical study on improving the therapeutic effect of postbiotics combined with immune checkpoint inhibitors in extensive-stage 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：	陈梦婷	研究负责人：	余慧青
Applicant：	Chen Mengting	Study leader：	Yu Huiqing
申请注册联系人电话： Applicant telephone：	+86 157 2305 3601	研究负责人电话： Study leader's telephone：	+86 159 0939 1166
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：	chenmengting@cqu.edu.cn	研究负责人电子邮件： Study leader's E-mail：	yhqdyx@cqu.edu.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：	重庆市沙坪坝区汉渝路181号	研究负责人通讯地址：	重庆市沙坪坝区汉渝路181号
Applicant address：	181 Hanyu Road, Shapingba District, Chongqing	Study leader's address：	181 Hanyu Road, Shapingba District, Chongqing
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：	重庆大学附属肿瘤医院
Applicant's institution：	Chongqing University Cancer Hospital
研究负责人所在单位：	重庆大学附属肿瘤医院
Affiliation of the Leader：	Chongqing University Cancer 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：	CZLS2022022-A-13; CZLS2022022-A	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：	重庆大学附属肿瘤医院伦理委员会
Name of the ethic committee：	Ethics Committee of Chongqing University Cancer Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2023-11-14 00:00:00
伦理委员会联系人：	汤晓华
Contact Name of the ethic committee：	Tang Xiaohua
伦理委员会联系地址：	重庆市沙坪坝区汉渝路181号
Contact Address of the ethic committee：	181 Hanyu Road, Shapingba District, Chongqing
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 23 6507 5696	伦理委员会联系人邮箱： Contact email of the ethic committee：	czll6545@126.com

研究实施负责（组长）单位：

重庆大学附属肿瘤医院

Primary sponsor：

Chongqing University Cancer Hospital

研究实施负责（组长）单位地址：

重庆市沙坪坝区汉渝路181号

Primary sponsor's address：

181 Hanyu Road, Shapingba District, Chongqing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	重庆市	市(区县)：
Country：	China	Province：	Chongqing	City：
单位(医院)：	重庆大学附属肿瘤医院	具体地址：	重庆市沙坪坝区汉渝路181号
Institution hospital：	Chongqing University Cancer Hospital	Address：	181 Hanyu Road, Shapingba District, Chongqing

经费或物资来源：

重庆市科学技术局

Source(s) of funding：

Chongqing Science and Technology Bureau

研究疾病：

小细胞肺癌

Target disease：

Small cell lung 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：

上市后药物

Study phase：

4

研究设计：

随机平行对照

Study design：

Parallel

研究目的：

本研究旨在评价高浓缩复合乳酸菌JK-5G联合免疫检查点抑制剂治疗广泛期小细胞肺癌的疗效、不良反应发生率

Objectives of Study：

The aim of this study is to evaluate the efficacy and toxicity of highly concentrated Lactobacillus complex JK-5G combined with immune checkpoint inhibitors in the treatment of extensive-stage small cell lung cancer

药物成份或治疗方案详述：

a. 免疫检查点抑制剂：每3周为1个给药周期，每个周期第1天静脉给予免疫检查点抑制剂 4.5mg/Kg剂量治疗，直至疾病进展或出现不可耐受的不良反应。 b.化疗药物：按照说明书进行使用。 c.高浓缩复合乳酸菌JK-5G：每日3次，每次1袋（2.5克），空腹温水冲饮。免疫抑制剂联合化疗方案 EC+斯鲁利单抗方案斯鲁利单抗 4.5mg/kg，静脉输注第1天（首次输注时间至少60分钟，如耐受良好，随后的输注时间至少维持30分钟）卡铂 AUC =5 静脉输注第1天（最高剂量不超过750mg）依托泊苷 100mg/m2 静脉输注第1-3天每3周重复，共4周期 4周期后斯鲁利单抗4.5mg/kg维持治疗，每3周重复，直至疾病进展或毒性不可耐受。

Description for medicine or protocol of treatment in detail：

a. Immune checkpoint inhibitor: 4.5mg/Kg of immune checkpoint inhibitor was given intravenously on day 1 of each 3-week dosing cycle until disease progression or intolerable adverse reactions occurred. b. Chemotherapy drugs: Use according to the manufacturer's instructions. c. High concentration complex lactic acid bacteria JK-5G: 3 times a day, 1 bag (2.5 g) each time, fasting warm water to drink. Immunosuppressant combined with chemotherapy EC+ slulizumab regimen Slulizumab 4.5mg/kg, IV infusion, day 1 (first infusion at least 60 minutes, subsequent infusions maintained for at least 30 minutes if well tolerated) Carboplatin AUC =5 Day 1 IV infusion (maximum dose not exceeding 750mg) Etoposide 100mg/m2 was infused intravenously on days 1-3 This was repeated every 3 weeks for 4 cycles After 4 cycles, maintenance treatment with slulizumab 4.5mg/kg was repeated every 3 weeks until disease progression or intolerable toxicity.

纳入标准：

1)组织学或细胞学确诊为小细胞癌，按照美国退伍军人肺癌协会(Veterans Administration Lung Study Group, VALG)分期为广泛期小细胞肺癌（ED-SCLC）
2)年龄：18 - 75岁，男女均可。
3)东部肿瘤协作组（ECOG）体力状况评分为0 - 1。
4)预期寿命 ≥ 12周。
5)既往抗肿瘤治疗或外科手术所致的所有急性毒性反应缓解至0 - 1级（根据NCI CTCAE 5.0版）或者至入组/排除标准所规定的水平。脱发等研究者认为对患者不产生安全性风险的其他毒性除外。
6)至少具有1个符合RECIST 1.1标准的可测量病灶。
7)患者可正常经口进食。
8)首剂研究药物前，实验室检查值满足以下条件：
a.血常规（筛查前 14 天内未输血、未使用造血刺激因子类药物纠正）：白细胞计数（white blood cell, WBC）≥3.0 × 10^9/L；绝对中性粒细胞计数（absolute neutrophil count, ANC）≥1.5 × 10^9/L；血小板（platelet, PLT）≥100 × 10^9/L；血红蛋白含量（hemoglobin, HGB）≥9.0 g/dL；
b.肝功能：无肝转移受试者天门冬氨酸氨基转移酶（aspartate transferase, AST）≤2.5 x ULN；丙氨酸肝氨基转移酶（alanine aminotransferase, ALT）≤2.5 x ULN，肝转移受试者其ALT、AST≤5 x ULN；血清总胆红素（total bilirubin, TBIL）≤1.5 x ULN (除外Gilbert 综合征总胆红素≤3.0 mg/dL) ；
c.肾功能：血清肌酐≤1.5 x ULN 或肌酐清除率 (creatinine clearance rate, CrCl) ≥50 mL/minute；
d.凝血功能：国际标准化比率（international normalized ratio, INR）≤1.5 x ULN，活化部分凝血活酶时间（activated partial thromboplastin time, APTT）≤1.5 x ULN（仅适用于目前没有接受抗凝治疗的患者，对于目前正在接受抗凝治疗的患者应接受稳定剂量的抗凝剂治疗）；
e.其他：脂肪酶≤1.5 x ULN（若脂肪酶>1.5 x ULN无临床或影像学证实胰腺炎的情况可以入组）；淀粉酶 ≤1.5 x ULN（若淀粉酶>1.5 x ULN 无临床或影像学证实胰腺炎的情况可以入组）；碱性磷酸酶（alkaline phosphatase, ALP）≤2.5ULN，肝转移或骨转移受试者，ALP≤5ULN。
9)育龄期女性受试者必须在开始研究用药前3天内进行血清妊娠试验，且结果为阴性，并且愿意在研究期间和末次给予研究药物后3个月内采用一种经医学认可的高效避孕措施（如：宫内节育器、避孕药或避孕套）；对于伴侣为育龄期女性的男性受试者，应为手术绝育，或同意在研究期间和末次研究给药后3个月内采用有效的方法避孕。
10)经本人同意并已签署知情同意书，愿意并有能力遵从计划的访视、研究治疗、实验室检查及其他试验程序。

Inclusion criteria

1) Histologically or cytologically confirmed small cell carcinoma, extensive-stage small cell Lung cancer (ED-SCLC) according to Veterans Administration Lung Study Group (VALG) stage
2) Age: 18-75 years old, both male and female.
3) Eastern Cooperative Oncology Group (ECOG) performance status score 0-1.
4) life expectancy ≥ 12 weeks.
5) resolution of all acute toxic effects from previous antineoplastic therapy or surgery to grade 0-1 (according to the NCI CTCAE, version 5.0) or to the level specified in the inclusion/exclusion criteria. Other toxicities, such as alopecia, that were deemed by the investigators not to pose a safety risk to patients were excluded.
6) At least one measurable lesion according to RECIST 1.1 criteria.
7) The patient could eat normally through the mouth.
8) Before the first dose of study drug, laboratory values should meet the following conditions:
a. blood routine (no blood transfusion or hematopoietic stimulation drugs within 14 days before screening) : white blood cell count (WBC) ≥3.0 × 10^9/L; absolute neutrophil count (ANC) ≥1.5 × 10^9/L; platelet (PLT) ≥100 × 10^9/L; hemoglobin (HGB) ≥9.0 g/dL;
b. Liver function: aspartate transferase (AST) ≤ 2.5x ULN in subjects without liver metastasis; alanine aminotransferase (ALT) ≤2.5 x ULN, ALT and AST≤5 x ULN in patients with liver metastasis; Serum total bilirubin (TBIL) ≤1.5 x ULN (except Gilbert's syndrome total bilirubin ≤3.0 mg/dL);
c. Renal function: serum creatinine ≤ 1.5x ULN or creatinine clearance rate (CrCl) ≥50 mL/minute;
d. Coagulation function: international normalized ratio (INR) ≤ 1.5x ULN, activated partial thromboplastin time (APTT) of 1.5 x ULN or less (only in patients who are not currently receiving anticoagulant therapy, and those who are currently receiving anticoagulant therapy should be treated with a stable dose of anticoagulant);
e. Others: lipase ≤ 1.5x ULN (if lipase > 1.5x ULN without clinical or imaging evidence of pancreatitis); Amylase ≤ 1.5x ULN (if amylase > 1.5x ULN without clinical or imaging evidence of pancreatitis); alkaline phosphatase (ALP) ≤2.5ULN, liver metastasis or bone metastasis, ALP≤5ULN.
9) Female participants of childbearing age must have taken a serum pregnancy test with a negative result within 3 days before starting study medication and be willing to use a medically approved, highly effective contraceptive (e.g., IUD, contraceptive pill, or condom) during the study and for 3 months after last administration of study medication; Male subjects whose partner is a female of reproductive age should be surgically sterilized or agree to use an effective method of contraception for the duration of the study and for 3 months after the last study dose.
10) Patients consented and signed the informed consent, willing and able to follow the planned visits, study treatments, laboratory tests, and other trial procedures .

排除标准：

1)无法正常经口进食者； 2)既往接受过任何T细胞共刺激或免疫检查点治疗，包括但不限于细胞毒性T淋巴细胞相关抗原-4（CTLA-4）抑制剂、PD-1抑制剂、PD-L1/2抑制剂或其他靶向T细胞的药物； 3)已知无法控制的或有症状的活动性中枢神经系统（CNS）转移，表现为出现临床症状、脑水肿、脊髓压迫、癌性脑膜炎、软脑膜疾病和/或进展性生长。有中枢神经系统转移或脊髓压迫病史的患者，如果明确接受过治疗且在研究首次给药前停用抗惊厥药和类固醇4周后临床表现稳定，则可以入组研究。 4)具有症状的、已播散到内脏的、短期内有出现危及生命的并发症风险的晚期患者（包括有无法控制的大量渗出液[胸腔、心包、腹腔]的患者），经研究者评定后不适应入组者； 5)患有特发性肺纤维化病史、机化性肺炎（如闭塞性细支气管炎）、药物诱导的肺炎、需要类固醇治疗的放射性肺炎或有临床症状的活动性肺炎；或其他严重影响肺功能的中重度肺部疾病（放射区存在放射性肺炎（纤维化）病史的患者可参加本研究）； 6)存在任何活动性自身免疫病或有自身免疫病病史且预期复发（包括但不局限于：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[仅通过激素替代治疗可以控制的受试者可纳入]；受试者患有无需全身治疗的皮肤病如白癜风、银屑病、脱发、I 型糖尿病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；需要支气管扩张剂进行医学干预的哮喘患者则不能纳入）。 7)活动性肺结核或筛选前≤48周内有活动性肺结核感染病史的受试者，无论是否治疗； 8)随机化时存在重度感染，包括但不仅限于需住院治疗的感染并发症、菌血症、重症肺炎等； 9)进入研究前的6个月内，出现以下情况：心肌梗死、严重/不稳定型心绞痛、NYHA 2级以上心功能不全以及有临床意义的室上性或室性心律失常而需要临床干预的患者； 10)HBsAg阳性且HBV DNA拷贝数大于所在研究中心检验科正常值上限（1000拷贝数/ml或500IU/ml ），或HCV阳性（HCV RNA或HCV Ab检测提示急慢性感染）；已知HIV阳性病史或已知的获得性免疫缺陷综合征（AIDS）； 11)进入研究前2年内曾患有其他活动性恶性肿瘤。可进行局部治疗且已治愈的皮肤基底细胞癌或鳞状细胞癌、浅表性膀胱癌、宫颈原位癌、乳腺导管内原位癌和甲状腺乳头状癌除外。 12)在随机前28天内接受过大型手术，或计划在研究期间接受大型手术； 13)首次研究药物治疗前28天内接受抗肿瘤治疗（包括化疗、放疗、免疫治疗、内分泌治疗、靶向治疗、生物治疗或者肿瘤栓塞术）；对于接受丝裂霉素和亚硝基脲治疗的患者不足6周者。 14)随机前28天内使用减毒活疫苗，或预计研究期间需要使用此种减毒活疫苗（随机前4周、治疗期间以及免疫检查点抑制剂末次给药后5个月内患者不允许接种流感减毒活疫苗）； 15)首次研究药物治疗前7天之内既往使用过免疫抑制药物，不包括喷鼻和吸入性皮质类固醇或生理剂量的系统性类固醇激素（即不超过10 mg/d泼尼松或同等药物生理学剂量的其他皮质类固醇）。 16)首次给药前4周内参与过任何其他药物临床研究，或距离末次研究用药不超过5个半衰期； 17)既往接受过同种异体骨髓移植或实体器官移植的患者； 18)已知对研究药物或辅料过敏，已知对任何一种单抗发生严重过敏反应； 19)已知有精神疾病、酗酒、无法戒烟、吸毒或药物滥用等情况； 20)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，不依从方案、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) unable to eat normally by mouth; 2) any prior T cell costimulation or immune checkpoint therapy, including but not limited to cytotoxic T lymphocyte-associated antigen-4 (CTLA-4) inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, or other T cell-targeting drugs; 3) known uncontrolled or symptomatic active central nervous system (CNS) metastases as indicated by the presence of clinical symptoms, cerebral edema, spinal cord compression, carcinomatous meningitis, leptomeningeal disease, and/or progressive growth. Patients with a history of central nervous system metastases or spinal cord compression could be enrolled if they were clearly treated and had a clinically stable condition 4 weeks after discontinuation of anticonvulsants and steroids before the first study dose. 4) patients with symptoms, visceral spread, and risk of life-threatening complications in the short term (including patients with uncontrollable large amount of exudate [pleural, pericardial, abdominal cavity]), who are not suitable for enrollment after evaluation by investigators; 5) a history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, radiation pneumonitis requiring steroid therapy, or clinically active pneumonitis; Or other moderate to severe lung diseases that seriously affect lung function (patients with a history of radiation pneumonitis (fibrosis) in the radiation area can participate in this study); 6) presence of any active autoimmune disease or a history of autoimmune disease with expected recurrence (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism [subjects controlled only with hormone replacement therapy were eligible]; Subjects with skin diseases requiring no systemic treatment such as vitiligo, psoriasis, alopecia, type I diabetes mellitus, or asthma that had resolved completely in childhood without any intervention in adulthood were included. Patients with asthma who required medical intervention with bronchodilators were excluded.) 7) active pulmonary tuberculosis or a history of active pulmonary tuberculosis infection within 48 weeks or less before screening, with or without treatment; 8) Severe infection at randomization, including but not limited to infectious complications requiring hospitalization, bacteremia, severe pneumonia, etc.; 9) patients with myocardial infarction, severe/unstable angina, NYHA class 2 or greater cardiac dysfunction, or clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention within 6 months before study entry; 10)HBsAg positive with HBV DNA copies greater than the upper limit of normal (1000 copies /ml or 500IU/ml), or HCV positive (HCV RNA or HCV Ab test indicated acute or chronic infection); A known history of HIV positivity or known acquired immunodeficiency syndrome (AIDS); 11) had other active malignancies within 2 years before study entry. Exceptions were basal-cell or squamous-cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, and papillary carcinoma of the thyroid that could be treated locally and cured. 12) had undergone major surgery within 28 days before randomization or were scheduled to undergo major surgery during the study period; 13) antineoplastic therapy (including chemotherapy, radiotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, or tumor embolization) within 28 days before the first dose of study drug; For patients treated with mitomycin and nitrosourea for less than 6 weeks. 14) use of live attenuated influenza vaccine within 28 days before randomization or anticipated need during the study (patients were not allowed to receive live attenuated influenza vaccine 4 weeks before randomization, during treatment, or within 5 months after the last dose of an immune checkpoint inhibitor); 15) previous use of immunosuppressive drugs within 7 days before the first study drug, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroids (i.e., not more than 10 mg/ day of prednisone or other corticosteroids at physiological doses of the drug). 16) participated in any other drug clinical study within 4 weeks before the first dose, or no more than 5 half-lives since the last study dose; 17) patients with prior allogeneic bone marrow or solid organ transplantation; 18) known allergy to the study drug or excipients, known severe allergic reaction to any of the mabs; 19) known mental illness, alcohol abuse, inability to quit smoking, drug or drug abuse; 20) According to the investigator's judgment, the subjects have other factors that may lead to the forced termination of the study, such as non-compliance with the protocol, other serious diseases (including mental disorders) requiring combined treatment, serious laboratory abnormalities, accompanied by family or social factors, which may affect the safety of the subjects, or the collection of data and samples.

研究实施时间：

Study execute time：

从 From 2024-03-01 00:00:00至 To 2026-03-01 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2024-03-01 00:00:00 至 To 2026-03-01 00:00:00

干预措施：

Interventions：

组别：	对照组	样本量：	100
Group：	Control group	Sample size：	100
干预措施：	PD-1 联合化疗	干预措施代码：
Intervention：	PD-1 plus chemotherapy	Intervention code：

组别：	试验组	样本量：	100
Group：	Experimental group	Sample size：	100
干预措施：	PD-1 联合化疗+后生素JK-5G	干预措施代码：
Intervention：	PD-1 combined with chemotherapy + PostbioticsJK-5G	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	重庆	市(区县)：	沙坪坝
Country：	China	Province：	Chongqing	City：	Shapingba
单位(医院)：	重庆大学附属肿瘤医院	单位级别：	三甲
Institution hospital：	Chongqing University Cancer Hospital	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	重庆	市(区县)：	綦江
Country：	China	Province：	Chongqing	City：	Qijiang
单位(医院)：	綦江区人民医院	单位级别：	三甲
Institution hospital：	Qijiang District People's Hospital	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	重庆	市(区县)：	江津
Country：	China	Province：	Chongqing	City：	Jiangjin
单位(医院)：	江津区第二人民医院	单位级别：	二甲
Institution hospital：	Jiangjin District Second people's Hospital	Level of the institution：	Secondary B

测量指标：

Outcomes：

指标中文名：	有效缓解率	指标类型：	主要指标
Outcome：	Objective Response Rate	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	生存质量	指标类型：	主要指标
Outcome：	Quality Of Life	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	无进展生存期	指标类型：	次要指标
Outcome：	Progression Free Survival	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	总生存期	指标类型：	次要指标
Outcome：	Overall survival	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

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：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	不良反应发生率	指标类型：	次要指标
Outcome：	Adverse Effects 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：	CD4+/CD8+ T淋巴细胞计数	指标类型：	次要指标
Outcome：	CD4 +/ CD8+ T lymphocytes count	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	肠道菌群16s DNA测序	指标类型：	次要指标
Outcome：	16S DNA sequencing of gut microbiota	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	血液炎性因子	指标类型：	次要指标
Outcome：	Blood inflammatory cytokines	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	血液代谢组学	指标类型：	次要指标
Outcome：	Metabolomics of blood	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：	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：

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	岁 years
最大 Max age	75	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）：

采用随机数字表进行随机分组，利用SAS统计分析系统产生随机数字表，所有入组研究对象按照随机数字表分派的随机数字进行随机分组

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

Using a random number table for random grouping, using the SAS statistical analysis system to generate a random number table, all enrolled study subjects were randomly grouped according to the random numbers assigned in the random number table

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：	双盲；对研究人员和受试者设盲
Blinding：	Double blind; Blinding researchers and subjects

是否共享原始数据： IPD sharing	是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）：	原始数据公开至中国临床试验注册中心 http://www.chictr.org.cn
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Raw data released to China Clinical Trial Center( http://www.chictr.org.cn)
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：	采用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：	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：	2024-02-07 15:00:33