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：	ChiCTR1800017111
最近更新日期： Date of Last Refreshed on：	2018-07-13 02:37:06
注册时间： Date of Registration：	2018-07-12 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	乳双歧杆菌M8对强直性脊柱炎疗效分析的临床随机双盲安慰剂对照研究
Public title：	Clinical randomized double-blind placebo-controlled study of Bifidobacterium Lactobacillus M8 in the treatment of ankylosing spondylitis
注册题目简写：
English Acronym：
研究课题的正式科学名称：	乳双歧杆菌M8对强直性脊柱炎疗效分析的临床随机双盲安慰剂对照研究
Scientific title：	Clinical randomized double-blind placebo-controlled study of Bifidobacterium Lactobacillus M8 in the treatment of ankylosing spondylitis
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：	高飞飞	研究负责人：	张剑
Applicant：	Feifei Gao	Study leader：	Jian Zhang
申请注册联系人电话： Applicant telephone：	+86 13061199360	研究负责人电话： Study leader's telephone：	+86 18606317005
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：	gaofeifei1985@163.com	研究负责人电子邮件： Study leader's E-mail：	72zj@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：	山东省威海市环翠区和平路70号	研究负责人通讯地址：	山东省威海市环翠区和平路70号
Applicant address：	70 Heping Road, Huancui District, Weihai, Shandong, China	Study leader's address：	70 Heping Road, Huancui District, Weihai, Shandong, 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：	山东省威海市立医院
Applicant's institution：	Weihai Municipal Hospital of Shandong
研究负责人所在单位：	山东省威海市立医院
Affiliation of the Leader：	Weihai Municipal Hospital of Shandong

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：	201816	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：	威海市立医院医学伦理委员会
Name of the ethic committee：	Medical ethics committee of Weihai Municipal Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2018-06-28 00:00:00
伦理委员会联系人：	邢宗杰
Contact Name of the ethic committee：	Zongjie Xing
伦理委员会联系地址：	山东省威海市环翠区和平路70号
Contact Address of the ethic committee：	70 Heping Road, Huancui District, Weihai, Shandong, China
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：

山东省威海市立医院

Primary sponsor：

Weihai Municipal Hospital of Shandong

研究实施负责（组长）单位地址：

山东省威海市环翠区和平路70号

Primary sponsor's address：

70 Heping Road, Huancui District, Weihai, Shandong, 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)：	山东	市(区县)：	威海市
Country：	China	Province：	Shandong	City：	Weihai
单位(医院)：	威海市立医院	具体地址：	山东省威海市环翠区和平路70号
Institution hospital：	Weihai Municipal Hospital	Address：	70 Heping Road, Huancui District, Weihai, Shandong, China

经费或物资来源：

内蒙古农业大学乳制品加工农业部重点实验室

Source(s) of funding：

Key Laboratory of dairy products processing, Ministry of agriculture, Inner Mongolia Agricultural University

研究疾病：

强直性脊柱炎

Target disease：

Ankylosing spondylitis

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：

其它

Study phase：

N/A

研究设计：

随机平行对照

Study design：

Parallel

研究目的：

观察、评价益生菌在治疗强直性脊柱炎患者中的疗效和安全性，并探讨其可能的作用机制。

Objectives of Study：

To observe and evaluate the efficacy and safety of probiotics in the treatment of ankylosing spondylitis, and to explore its possible mechanism.

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. men or women, aged 18 and -45, need to ensure that non pregnant women can be included in the non pregnant and non lactation periods during the reproductive period;
2. at least 3 months before entering the group, it was in line with the 1984 New York AS standard and was diagnosed as AS;
3. AS was in the active period, that is, the Bath ankylosing spondylitis disease activity index (BASDAI) is greater than 4, the total pain score is more than 4 (using the visual analogue scale (VS) evaluation, unit 0-10cm), the morning stiffness is more than 30 minutes, and the erythrocyte sedimentation rate (ESR) and the C- reactive protein (CRP) are higher than the normal value;
4. did not take NSAIDs drugs before taking part in the group, or had taken NSAIDs but had been discontinued for at least 2 weeks;
5. no biological agent or glucocorticoid or sulfasalazine has been used or used for at least 3 months;
6. had received methotrexate, leflunomide, thalidomide, or hydroxychloroquine for at least 3 months before entering the group, and did not appear to be due to the improvement of the severe side effects of the anti rheumatic drug (DMARDs), especially no gastrointestinal reaction, and at least 4 weeks before the entry of the group;
7. no antibiotics, gastrointestinal motility drugs, probiotics or microecological active agents (such as yogurt) were used in the 1 months before treatment;
8. there is no history of major organ involvement, such as kidney, pancreas, gastrointestinal diseases, etc.;
9. there was no history of infectious gastrointestinal diseases such as diarrhoea or dysentery in the first 1 months;
10. no gastrointestinal surgery in the near future;
11. the drug compliance is good and can cooperate with the clinical research.

排除标准：

1.病情稳定者，
2.脊柱完全强直者（脊柱侧位X线片可见各椎体间平面韧带骨赘桥接），
3.近3个月使用过或近期打算使用任何一种生物制剂或糖皮质激素或柳氮磺吡啶，
4.治疗前1个月内使用抗生素、胃肠动力药物、益生菌或微生态活菌制剂（例如酸奶）等制品，
5.有重要脏器受累病史，如慢性肾衰、肾炎、胰腺炎、肝病、胃溃疡等，
6.合并恶性肿瘤者，尤其是消化道肿瘤患者,
7.采样前1个月内有腹泻、痢疾等感染性胃肠道病史，与强直性脊柱炎病情相关的腹泻不在此范围内，
8.近期有胃肠道手术，
9.药物依从性差及不配合患者，不愿意接受随机、双盲对照试验患者，
10.孕妇、哺乳期妇女，
11.同时接受其他临床试验患者，
12.对受试样品过敏或出现明显消化道症状如不能耐受者，
13.诊断为艾滋病毒/艾滋病或肝脏疾病的患者，
15.依赖管制药物或/和酒精的患者，
16.拒绝签署知情同意书的患者，
17.随访期间服用抗生素的患者，
18.随访期间饮食习惯不规律，有较大变动的患者，
19.文盲及聋哑人，无法评估自己疼痛感觉者。

Exclusion criteria：

1. stable patients;
2. the spine is completely rigid;
3. nearly 3 months have used or intended to use any biological agent or glucocorticoid or sulfasalazine in the near future;
4. antibiotics, gastrointestinal motility drugs, probiotics or microecological active agents (such as yogurt) were used within 1 months before treatment;
5. there is a history of major organ involvement, such as chronic renal failure, nephritis, pancreatitis, liver disease, gastric ulcer and so on;
6. patients with malignant tumors, especially those with digestive tract cancer;
7. there was a history of infectious gastrointestinal diseases such as diarrhoea and dysentery in the first 1 months, and diarrhea related to ankylosing spondylitis was not in this area;
8. recent gastrointestinal surgery;
9. patients with poor drug compliance and incompatibility with patients are unwilling to accept a randomized, double-blind, controlled trial;
10. pregnant women, breast-feeding women;
11. at the same time, the patients received other clinical trials;
12. allergic reaction to the sample or obvious gastrointestinal symptoms such as intolerance;
13. patients diagnosed with HIV / AIDS or liver diseases;
15. patients who rely on the control of drugs or / and alcohol;
16. patients who refused to sign the informed consent form;
17. patients who took antibiotics during the follow-up period;
18. during the follow-up period, patients with irregular eating habits and larger changes were found;
19. illiterates and deaf mutes can not evaluate their own pain receptors.

研究实施时间：

Study execute time：

从 From 2018-07-20 00:00:00至 To 2019-07-20 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2018-07-20 00:00:00 至 To 2018-04-20 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	30
Group：	experimental group	Sample size：	30
干预措施：	乳双歧杆菌M8	干预措施代码：
Intervention：	Bifidobacterium Lactobacillus M8	Intervention code：

组别：	对照组	样本量：	30
Group：	Control group	Sample size：	30
干预措施：	安慰剂	干预措施代码：
Intervention：	Placebo	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	山东	市(区县)：
Country：	China	Province：	Shandong	City：
单位(医院)：	威海市立医院	单位级别：	三级甲等
Institution hospital：	Weihai Municipal Hospital	Level of the institution：	Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：	Bath强直性脊柱炎功能指数	指标类型：	主要指标
Outcome：	Bath ankylosing spondylitis function index	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	Bath强直性脊柱炎病情活动指数	指标类型：	主要指标
Outcome：	Bath disease activity index of ankylosing spondylitis	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	Bath强直性脊柱炎计量指数	指标类型：	主要指标
Outcome：	Bath ankylosing spondylitis measurement index	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	旧金山加利福尼亚大学（UCSF）附着点炎指数	指标类型：	主要指标
Outcome：	Attachment index of University of California (UCSF), San Francisco	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：	Faeces	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：

正在进行

Recruiting

年龄范围：

Participant age：

最小 Min age	18	岁 years
最大 Max age	45	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）：

威海市立医院统计人员通过计算机生成随机序列号

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

Weihai municipal hospital statisticians generate random serial numbers by computer.

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	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）：	发表学术论文
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Publish an academic paper
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 table
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：	2018-07-13 02:37:06