ChiCTR2100053568 版本V1.4 版本创建时间2022/05/20 16:12:01 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：

ChiCTR2100053568 

最近更新日期：

Date of Last Refreshed on：

2022-05-20 16:09:16 

注册时间：

Date of Registration：

2021-11-24 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

益生菌联合HAART治疗在改善艾滋病患者肠黏膜屏障及免疫炎症中的作用

Public title：

Effect of probiotics combined with HAART on improving intestinal mucosal barrier and immune inflammation in AIDS patients

注册题目简写：

English Acronym：

研究课题的正式科学名称：

益生菌联合HAART治疗在改善艾滋病患者肠黏膜屏障及免疫炎症中的作用

Scientific title：

Effect of probiotics combined with HAART on improving intestinal mucosal barrier and immune inflammation in AIDS patients

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：

黄银秋 

研究负责人：

荣黎 

Applicant：

Huang Yinqiu 

Study leader：

Rong Li 

申请注册联系人电话：

Applicant telephone：

+86 23 65481658

研究负责人电话：

Study leader's telephone：

+86 13883886491

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：

huangyinqiu917@163.com

研究负责人电子邮件：

Study leader's E-mail：

lirongcq@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：

重庆市沙坪坝区歌乐山镇保育路109号

研究负责人通讯地址：

重庆市沙坪坝区歌乐山镇保育路109号

Applicant address：

109 Baoyu Road, Geleshan Town, Shapingba District, Chongqing

Study leader's address：

109 Baoyu Road, Geleshan Town, 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：

重庆市公共卫生医疗救治中心

Applicant's institution：

Chongqing Public Health Medical Center

研究负责人所在单位：

Affiliation of the Leader：

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：

2021-039-01-KY

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：

重庆市公共卫生医疗救治中心伦理委员会

Name of the ethic committee：

The Ethics Committee of Chongqing Public Health Medical Center

伦理委员会批准日期：

Date of approved by ethic committee：

2021-10-25 00:00:00

伦理委员会联系人：

陈亚玲

Contact Name of the ethic committee：

Chen Yaling

伦理委员会联系地址：

重庆市沙坪坝区歌乐山镇保育路109号

Contact Address of the ethic committee：

109 Baoyu Road, Geleshan Town, Shapingba District, Chongqing

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：

重庆市公共卫生医疗救治中心

Primary sponsor：

Chongqing Public Health Medical Center

研究实施负责（组长）单位地址：

重庆市沙坪坝区歌乐山镇保育路109号

Primary sponsor's address：

109 Baoyu Road, Geleshan Town, 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(区县)：

Country：

China

Province：

Chongqing

City：

单位(医院)：

重庆市公共卫生医疗救治中心

具体地址：

沙坪坝区歌乐山镇保育路109号

Institution
hospital：

Chongqing Public Health Medical Center

Address：

109 Baoyu Road, Geleshan Town, Shapingba District

经费或物资来源：

重庆市科卫联合医学科研项目

Source(s) of funding：

Chongqing Municipal Science and Health Joint Medical Research Project

Target disease：

HIV-infected patients with intestinal disease

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

研究设计：

队列研究 

Study design：

Cohort study 

研究目的：

1.观察益生菌制剂联合HAART治疗对艾滋病相关肠道症状的改善情况； 2.基于肠道活检，应用16SrRNA测序技术进行肠道微生物群分类和鉴定，观察益生菌治疗对艾滋病患者肠道菌群紊乱的调节作用以及对肠黏膜屏障功能相关指标的影响； 3.联合血清学检测，观察益生菌治疗对艾滋病患者肠道免疫炎症相关指标的影响。  

Objectives of Study：

1. To observe the improvement of AIDS-related intestinal symptoms with probiotic preparations combined with HAART treatment; 2. Based on intestinal biopsy, 16S rRNA sequencing technology was used to classify and identify the intestinal microbiota, and to observe the regulating effect of probiotic treatment on intestinal flora disturbance in AIDS patients and the effect on the related indicators of intestinal mucosal barrier function; 3. Combined with serological detection, the effect of probiotics treatment on intestinal immune inflammation-related indicators in AIDS patients was observed.

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.符合艾滋病症诊断标准并伴随腹泻、腹胀、腹痛、腹鸣、便秘、里急后重等肠道相关症状的初诊患者；
2.年龄18岁-70岁；男女不限；
3.近期未接受过益生菌、益生元等治疗；
4.生活饮食规律，病情相对稳定；
5.无重大合并症；
6.沟通无障碍，依从性较好；
7.签署知情同意书。

Inclusion criteria

1. Newly diagnosed patients who meet the diagnostic criteria of AIDS and are accompanied by diarrhea, abdominal distension, abdominal pain, abdominal belching, constipation, tenesmus and other intestinal-related symptoms;
2. Aged 18-70 years; no gender limit;
3. Have not received probiotics, prebiotics and other treatments recently;
4. Living and eating regularly, the condition is relatively stable;
5. No major comorbidities;
6. Communication is barrier-free and compliance is good;
7. Sign the informed consent.

排除标准：

1.对受试药物过敏或存在严重副反应，不能耐受者；
2.妊娠及哺乳期妇女；
3.合并严重心、肺、肝、肾等疾病而不适合肠镜检查及肠道活检者；
4.合并机会性感染、炎症性肠病、肠白塞氏病、肠道肿瘤等；
5.近期参与过其它临床研究；
6.近四周服用过对肠道屏障有显著影响的药物，如二甲双胍、磺胺、抗生素、抗真菌药等；
7.其它可能对研究产生显著影响的因素。

Exclusion criteria：

1. Those who are allergic to the test drug or have serious side effects and cannot tolerate it;
2. Pregnant and lactating patients;
3. Those with severe heart, lung, liver, kidney and other diseases who are not suitable for colonoscopy and intestinal biopsy;
4. Combined with opportunistic infection, inflammatory bowel disease, intestinal Behcet's disease, intestinal tumor, etc.;
5. Participated in other clinical studies recently;
6. Taking drugs that have a significant impact on the intestinal barrier in the past four weeks, such as metformin, sulfonamides, antibiotics, antifungal drugs, etc.;
7. Other factors that may have a significant impact on the study.

研究实施时间：

Study execute time：

从 From 2021-11-10 00:00:00至 To 2024-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2021-11-12 00:00:00 至 To 2024-12-31 00:00:00  

干预措施：

Interventions：

组别：

对照组

样本量：

10

Group：

Control Group

Sample size：

干预措施：

仅给予ART

干预措施代码：

Intervention：

Only ART

Intervention code：

组别：

双歧杆菌组

样本量：

10

Group：

Bifidobacterium Group

Sample size：

干预措施：

ART联合双歧杆菌乳杆菌三联活菌片

干预措施代码：

Intervention：

ART combined with bifidobacteria and Lactobacillus triplex viable tablets

Intervention code：

组别：

枯草杆菌组

样本量：

10

Group：

Bacillus Subtilis Group

Sample size：

干预措施：

ART联合枯草杆菌二连活菌肠溶胶囊

干预措施代码：

Intervention：

ART combined with Bacillus subtilis erectile enteric-soluble capsule

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)：

  

Country：

China 

Province：

Chongqing 

City：

 

单位(医院)：

重庆市公共卫生医疗救治中心 

单位级别：

三级 

Institution
hospital：

Chongqing Public Health Medical Center

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

治疗前后肠组织中紧密连接相关蛋白 Claudin-1、Occludin、ZO-1 表达情况

指标类型：

主要指标

Outcome：

The expression of tight junction related proteins Claudin-1, Occludin and ZO-1 in intestinal tissue before and after treatment

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

治疗前后肠道免疫炎症因子表达情况

指标类型：

次要指标

Outcome：

Expression of intestinal immune inflammatory factors before and after treatment

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

治疗前后安全性比较

指标类型：

次要指标

Outcome：

Comparison of safety before and after treatment

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

治疗前后血浆中肠粘膜损伤/微生物易位相关指标

指标类型：

次要指标

Outcome：

Plasma midgut mucosal injury/microbial translocation before and after treatment

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：

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：

标本中文名：

肠粘膜

组织：

Sample Name：

Intestinal mucosa

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 17 岁 years
最大 Max age 70 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）：

非随机

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

Nonrandom

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：

Blinding：

是否共享原始数据：

IPD sharing

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）：

试验完成后6个月内发表论文

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

Publish papers within six months after the trial complete

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：

数据管理 本研究采用医研通数据平台进行电子化数据管理，在试验启动之前对参加人员进行相关培训。数据管理方根据病例报告表构建e-CRF，并根据研究者提供的信息创建账号。 1 数据记录 1）研究者填写临床试验记录要求：及时、准确、完整、规范、真实； 2）全部病例均按方案规定，认真书写病历和病例报告表，所有项目均需填写，不得空项、漏项（无记录的空格划斜线）。 3）病历及病例报告表作为原始记录，做任何更正时只能划线，旁注修改后数据，说明理由并由参加临床试验的医师和研究者签名并注明日期，不得擦涂、覆盖原始记录。 4）化验单齐全并粘贴在病例报告表上，病例报告表记录的数据要与病历及原始检验报告核对无误。 5）对显著异常或在临床可接受范围以外的数据（实验室检查项目超过正常值的20%）需加以合适，由参加临床试验的医师做必要的说明。 6）每一位受试者观察疗程结束后，研究者应在3个工作日内将病例报告表及病历交本单位主要研究者审核、签名。 2 数据监察 1）主研单位质控人员在试验过程中要核查研究者是否遵循试验方案，定期去各试验中心检查受试者的知情同意及筛选纳入情况； 2）确认所有病例报告表填写及时、正确，并与原始资料真实、一致；所有错误或遗漏均已改正或注明，经研究者签名并注明日期；每一受试者的剂量改变、治疗变更、合并用药、间发疾病、检查遗漏等均应确认并记录； 3）核实入选受试者的退出须在病例报告表中予以说明；确认所有不良事件均应记录在案，严重不良事件在规定时间内作出报告并记录在案；核实试验用药品是否按照有关规定进行供应、储藏、分发、回收，并做相应的记录。 3 数据保存 1）建立数据库：根据病例报告表的项目采用医研通数据平台建立相应录入程序，并设定录入时的逻辑审查限定条件，对数据库进行试运行，建立本试验专用的数据库系统。 2）录入前再次核查：对病例报告表进一步检查。已经审核声明签字的病例报告表交数据管理员，数据管理员对日期、入组标准、排除标准、脱落、缺失值等进行检查，如有疑问，可填写疑问表返回检察员，由研究者对疑问表中的问题进行书面解答并签名，交回数据管理员，疑问表应妥善保管。 3）数据录入：e-CRF数据来源于原始记录，由研究者根据e-CRF填写说明，将受试者研究数据及时录入医研通数据平台中，保证数据的真实、准确、完整、及时，并需确保与受试者原始病历数据核对一质性。 4）数据审核：采用计算机软件中的核查功能进行逻辑检查与自动比较，查对与病例报告表不一致的结果值，然后逐项与原始病例报告表核对，予以更正。再进行病例报告表和数据库中的数据与病例报告表中的结果一致。 5）数据锁定：由主要研究者、申办者，统计分析人员和数据管理人员共同签署数据锁定记录后，数据管理员进行数据库锁定。

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

Data Management In this study, the medical research and development data platform was used for electronic data management, and participants were trained before the trial started. The data management party builds an e-CRF based on the case report form and creates an account based on the information provided by the researcher. 1. Data Recording 1) The researcher fills in the clinical test record requirements: timely, accurate, complete, standardized, and true; 2) All cases are written according to the regulations, and the medical records and case report forms are carefully written. All items need to be filled out, and no empty items or missing items (with no recorded spaces); 3) The medical record and case report form are used as the original records. Any corrections can only be crossed, and the revised data should be inserted. The reasons are indicated and signed and dated by the doctors and researchers participating in the clinical trial. recording; 4) The test list is complete and pasted on the case report form, and the data recorded in the case report form should be checked against the medical record and the original test report; 5) Appropriate abnormality or data outside the clinically acceptable range (laboratory items exceeding 20% of the normal value) should be appropriate, and the necessary explanation should be given by the physician participating in the clinical trial; 6) After the end of the observation course, the investigator shall review and sign the case report form and the medical record to the main investigator of the unit within 3 working days; 2. Data monitoring 1) The quality control personnel of the main research unit should check whether the researcher follows the test plan during the test, and regularly go to each test center to check the subject's informed consent and screening and inclusion; 2) Confirm that all case report forms are filled in correctly and correctly, and are true and consistent with the original materials; all errors or omissions have been corrected or indicated, signed and dated by the investigator; dose change and treatment of each subject Changes, combined medications, intermittent illnesses, and omissions should be confirmed and recorded; 3) Verification of the withdrawal of the selected subjects shall be stated in the case report form; confirmation that all adverse events shall be recorded, serious adverse events shall be reported and recorded within the specified time; verification of whether the test drugs are in accordance with relevant regulations Supply, store, distribute, recycle, and record accordingly. 3 data saving 1) Establish database: According to the project of the case report form, use the medical research data platform to establish the corresponding entry procedure, and set the logical review qualification conditions at the time of entry, test run the database, and establish a database system dedicated to the test; 2) Check again before entering: further check the case report form. The case report form signed by the audited statement is submitted to the data administrator. The data manager checks the date, the entry criteria, the exclusion criteria, the dropout, the missing value, etc. If in doubt, you can fill in the question form and return to the inspector. The questions in the question form are answered in writing and signed, and returned to the data administrator. The question form should be kept in a safe place; 3) Data entry: The e-CRF data is derived from the original record. The researcher fills in the e-CRF instructions and records the subject research data into the medical research data platform in time to ensure the data is true, accurate, complete and timely. It is also necessary to ensure that the original medical record data of the subject is checked for qualitative; 4) Data audit: Use the verification function in the computer software to perform logical check and automatic comparison, check the result value that is inconsistent with the case report form, and then check the original case report form item by item and correct it. The data in the case report form and the database are consistent with the results in the case report form; 5) Data lock: After the data lock record is signed by the main researcher, sponsor, statistical analyst and data management personnel, the data administrator performs database lock.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2021-11-24 09:46:35