今天是:2020-08-11 星期二

双歧杆菌四联活菌片(思连康)治疗腹泻型肠易激综合 征的临床疗效和安全性研究——一项随机、双盲、 安慰剂对照、多中心临床试验
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注册号:

Registration number:

ChiCTR1800017721 

最近更新日期:

Date of Last Refreshed on:

2018-08-10 

注册时间:

Date of Registration:

2018-08-10 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

双歧杆菌四联活菌片(思连康)治疗腹泻型肠易激综合 征的临床疗效和安全性研究——一项随机、双盲、 安慰剂对照、多中心临床试验 

Public title:

Bifidobacterium quadruple viable tablets (Siliankang) in the treatment of diarrhea predominant irritable bowel syndrome study on the clinical efficacy and safety of signs: a randomized, double-blind, placebo-controlled, multicenter trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

双歧杆菌四联活菌片(思连康)治疗腹泻型肠易激综合 征的临床疗效和安全性研究——一项随机、双盲、 安慰剂对照、多中心临床试验 

Scientific title:

Bifidobacterium quadruple viable tablets (Siliankang) in the treatment of diarrhea predominant irritable bowel syndrome study on the clinical efficacy and safety of signs: a randomized, double-blind, placebo-controlled, multicenter trial 

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:

白涛 

研究负责人:

侯晓华 

Applicant:

Tao Bai 

Study leader:

Xiaohua Hou 

申请注册联系人电话:

Applicant telephone:

+86 15802734363 

研究负责人电话:

Study leader's telephone:

+86 027 85726057 

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:

drbaitao@126.com 

研究负责人电子邮件:

Study leader's E-mail:

houxh@medmail.com.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:

湖北省武汉市解放大道1277号 

研究负责人通讯地址:

湖北省武汉市解放大道1277号 

Applicant address:

1277 Jiefang Avenue, Wuhan, Hubei, China 

Study leader's address:

1277 Jiefang Avenue, Wuhan, Hubei, 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:

华中科技大学同济医学院附属协和医院 

Applicant's institution:

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 

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:

2018-137 

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:

华中科技大学药物临床试验伦理委员会 

Name of the ethic committee:

Clinical Trial Ethics Committee of Huazhong University of Science and Technology 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-06-25 

伦理委员会联系人:

陈汇 

Contact Name of the ethic committee:

Hui Chen 

伦理委员会联系地址:

湖北省武汉市航空路13号 

Contact Address of the ethic committee:

13 Hangkong Road, Wuhan, Hubei, 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:

华中科技大学同济医学院附属协和医院 

Primary sponsor:

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 

研究实施负责(组长)单位地址:

湖北省武汉市解放大道1277号 

Primary sponsor's address:

1277 Jiefang Avenue, Wuhan, Hubei, 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):

浙江

市(区县):

杭州

Country:

China

Province:

Zhejiang

City:

单位(医院):

杭州远大生物制药有限公司

具体地址:

浙江省杭州市江干区九环路63号

Institution
hospital:

Hangzhou Grand Biologic Pharmaceutical. INC

Address:

63 Jiuhuan Road, Jianggan District, Hangzhou, Zhejiang

国家:

中国

省(直辖市):

湖北

市(区县):

武汉

Country:

China

Province:

Hubei

City:

单位(医院):

华中科技大学同济医学院附属协和医院

具体地址:

湖北省武汉市解放大道1277号

Institution
hospital:

Huazhong University of Science and Technology Tongji Medical College Affiliated Union Hospital

Address:

1277 Jiefang Avenue, Wuhan, Hubei, China

经费或物资来源:

杭州远大生物制药有限公司 

Source(s) of funding:

Sponsored by Hangzhou Grand Biologic Pharmaceutical. INC 

研究疾病:

腹泻型肠易激综合征 

Target disease:

Diarrhea predominant irritable bowel syndrom 

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:

研究目的:

评价双歧杆菌四联活菌片(思连康)治疗IBS-D的有效性和安全性 

Objectives of Study:

To evaluate the efficacy and safety of Bifidobacterium tetra viable tablets (Siliankang) in the treatment of IBS-D.  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1. 患者自愿参加,并且签署知情同意书; 2. 年龄18-65周岁; 3. 罗马IV诊断标准明确诊断为腹泻型肠易激综合征(IBS-D); 4. 筛选期第二周(治疗开始前7天)患者每周至少有2天报告发生腹痛,且最严重腹痛的平均值≥3.0(11-分制NRS报告),至少2天出现粪便性状分型为6 型或7 型; 5. 筛选期(即治疗阶段开始前的14±3天期间)患者完整完成症状日志记录至少10天; 6. 患者停用在筛选前阶段针对腹部症状或腹泻的违反方案的药物; 7. 患者访视期间生活方式不作任何可能影响腹泻、腹痛症状的重大改变(例如,开始一种新的饮食,或改变通常的运动模式); 8. 两年内国内三级以上医院结肠镜检查报告正常或研究者认为无临床意义的异常结果,(如因充血水肿诊断的慢性结肠炎,但无糜烂溃疡;有结肠息肉直径小于等于3mm且数量少于5枚)。 

Inclusion criteria

1. Patients participated voluntarily and signed informed consent; 2. Aged 18-65 years old; 3. Patients were diagnosed as diarrhea predominant irritable bowel syndrome (IBS-D) by Rome IV criteria; 4. After two weeks of screening (7 days before the beginning of treatment), patients have abdominal pain at least 2 days a week, and the mean value of the most severe abdominal pain was more than 3 (11- NRS report). Meanwhile, the fecal traits were classified as type 6 or 7 at least 2 days; 5. During the screening period (14 + 3 days before the onset of treatment), the patients completed the symptom log for at least 10 days; 6. Patients discontinued the drugs used in the pre screening stage for abdominal symptoms or diarrhea; 7. The lifestyle during the visit did not make any significant changes in the symptoms of diarrhea and abdominal pain (for example, starting a new diet, or changing the usual exercise pattern); 8. Colonoscopy report within two years of tertiary hospitals in China was normal or the researchers considered no clinical significance (such as chronic colitis diagnosed by congestion and edema, but no erosive ulcer; the diameter of colonic polyps was less than 3mm and the number was less than 5). 

排除标准:

1. 肠道器质性疾病,如炎症性肠病、肠结核、吸收不良综合征、乳糜泻、乳糖不耐受或其他器质性疾病; 2. 既往有腹部及盆腔手术史,比如胆囊切除术等(阑尾切除术、剖腹产术后未出现肠道并发症如肠梗阻的患者,及肠道息肉内镜下治疗除外); 3. 有慢性胰腺炎、肿瘤、消化性溃疡、结核性腹膜炎、慢性肝病、肝硬化等消化系统非肠道疾病(B超诊断慢性胆囊炎患者若无典型胆绞痛可以入组); 4. 大便常规结果异常:大便隐血(+)或红细胞(+)或白细胞(+); 5. 有全身其他严重系统疾病,包括心、肺、肾等重要脏器有严重病变,免疫调节性疾病,代谢性疾病(糖尿病、甲状腺功能亢进或甲状腺功能减低)或恶性肿瘤等,生殖系统疾病如卵巢囊肿,子宫内膜异位等; 6. 实验室检查有显著异常,研究者认为不适合参加和完成研究的: A.血红蛋白<1xLLN; B.血清肌酐≥1xULN;或者肌酐清除率≤1xLLN; C.肝功能异常,定义为AST>1.5xULN和/或ALT>1.5xULN 和/或总胆红素>1.5xULN 7. 严重精神疾病患者,或HAMD评分>20分,或HAMA评分>29分; 8. 筛选前腹痛主要发生在夜间,有不明原因的消瘦,发热,黄疸,血便或黑便,或BMI≤17; 9. 有药物滥用或酒精滥用病史者(酒精或药物使用造成的异常适应状态,可导致临床病态,在12个月内出现至少一下1项表现:A.反复使用药物或酒精导致工作、学业或家庭责任的过失或失败,B.在躯体有危险的某种场合多次使用药物或酒精,C.多次发生与药物或酒精应用有关的法律问题,D.尽管由于药物或酒精带来社交或人际关系问题,仍继续用该物质)及对本药物过敏者; 10. 在试验中无法停用影响胃肠道运动和功能的伴随用药,如抗生素、肠道微生态制剂、质子泵抑制剂等; 11. 妊娠期或哺乳期或计划在试验期间怀孕的妇女; 12. 正在参加或完成其他临床试验后不满3个月; 其他研究者认为不适合入选者 

Exclusion criteria:

1. Having intestinal organic diseases, such as inflammatory bowel disease, intestinal tuberculosis, malabsorption syndrome, celiac disease, lactose intolerance, or other organic diseases; 2. Having history of abdominal and pelvic surgery, such as cholecystectomy (patients accepted appendectomy, patients who did not have intestinal complications after caesarean section, such as intestinal obstruction, and patients accepted endoscopic treatment of intestinal polyps can be included); 3. Having chronic pancreatitis, tumors, peptic ulcers, tuberculous peritonitis, chronic liver disease, liver cirrhosis and other digestive system non intestinal diseases (B ultrasonic diagnosis of chronic cholecystitis patients without typical biliary colic can be included); 4. Stool routine results were abnormal: fecal occult blood (+) or red blood cells (+) or white blood cells (+); 5. Having other serious systemic diseases, including serious diseases such as heart, lung, kidney and other important organs, immunomodulatory diseases, metabolic diseases (diabetes, hyperthyroidism or hypothyroidism) or malignant tumors, and other diseases such as ovarian cysts and endometriosis; 6. Laboratory tests showed significant abnormalities; (1) hemoglobin < 1xLLN; (2) serum creatinine was more than 1xULN, or creatinine clearance was less than 1xLLN; (3) abnormal liver function is defined as AST > 1.5xULN and / or ALT > 1.5xULN and / or total bilirubin > 1.5xULN; 7. Patients with severe mental illness or HAMD score > 20 points, or HAMA score > 29 points; 8. Abdominal pain occurs mainly at night during screening period, patients with unexplained emaciation, fever, jaundice, bloody stool or black stool, or BMI < 17; 9. Patients with a history of drug abuse or alcohol abuse (the abnormal adaptation caused by alcohol or drug use can lead to clinical morbid state, and at least 1 manifestations in 12 months: A. Repeated use of drugs or alcohol to cause negligence or failure in work, academic or family responsibility, and B. Use drugs or alcohol repeatedly on occasions where the body is in danger. C. Legal problems related to the use of drugs or alcohol repeatedly D. Although drugs or alcohol cause social or interpersonal problems, they continue to use this substance.) and those who are allergic to the drug; 10. During the experiment, the accompanying drugs that affect gastrointestinal motility and function cannot be stopped, such as antibiotics, intestinal microecologic agents, proton pump inhibitors, etc. 11. Pregnant or breast-feeding women who plan to be pregnant during the trial period; 12. Less than 3 months after attending or completing other clinical trials; 13. Researchers think it is not suitable for the candidates. 

研究实施时间:

Study execute time:

From2018-08-01To 2020-04-15 

征募观察对象时间:

Recruiting time:

From2018-08-01To 2020-03-01 

干预措施:

Interventions:

组别:

试验组

样本量:

150

Group:

Experimental group

Sample size:

干预措施:

双歧杆菌四联活菌片

干预措施代码:

Intervention:

Bifidobacterium quadruple viable tablets

Intervention code:

组别:

对照组

样本量:

150

Group:

Control group

Sample size:

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):

湖北 

市(区县):

武汉 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

华中科技大学同济医学院附属协和医院 

单位级别:

三级甲等 

Institution
hospital:

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

北京 

Country:

China 

Province:

Beijing 

City:

Beijing 

单位(医院):

北京协和医院 

单位级别:

三级甲等 

Institution
hospital:

Peking Union Medical College Hospita  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

北京 

Country:

China 

Province:

Beijing 

City:

Beijing 

单位(医院):

中国中医科学院望京医院 

单位级别:

三级甲等 

Institution
hospital:

Wangjing Hospital, Chinese Academy of Traditional Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

北京 

Country:

China 

Province:

Beijing 

City:

Beijing 

单位(医院):

北京积水潭医院 

单位级别:

三级甲等 

Institution
hospital:

Beijing Jishuitan Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

浙江大学医学院附属邵逸夫医院 

单位级别:

三级甲等 

Institution
hospital:

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

杭州 

Country:

China 

Province:

Zhejiang 

City:

Hangzhou 

单位(医院):

浙江省中医院 

单位级别:

三级甲等 

Institution
hospital:

Zhejiang Provincial Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

吉林 

市(区县):

长春 

Country:

China 

Province:

Jilin 

City:

Changchun 

单位(医院):

吉林大学中日联谊医院 

单位级别:

三级甲等 

Institution
hospital:

Jilin University China-Japan Friendship Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

吉林 

市(区县):

长春 

Country:

China 

Province:

Jilin 

City:

Changchun 

单位(医院):

吉林省人民医院 

单位级别:

三级甲等 

Institution
hospital:

Jilin Provincial People's Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

河南 

市(区县):

洛阳 

Country:

China 

Province:

He'nan 

City:

Luoyang 

单位(医院):

洛阳市第一人民医院 

单位级别:

三级 

Institution
hospital:

The First People's Hospital Of Luoyang  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

河南 

市(区县):

新乡 

Country:

China 

Province:

He'nan 

City:

Xinxiang 

单位(医院):

新乡市第一人民医院 

单位级别:

三级 

Institution
hospital:

The First People's Hospital Of Xinxing  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

江苏 

市(区县):

连云港 

Country:

China 

Province:

Jiangsu 

City:

Lianyungang 

单位(医院):

连云港市中医院 

单位级别:

三级甲等 

Institution
hospital:

Lianyungang City Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

荆州 

Country:

China 

Province:

Hubei 

City:

Jingzhou 

单位(医院):

荆州市中医院 

单位级别:

三级甲等 

Institution
hospital:

Jingzhou Chinese Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

陕西 

市(区县):

延安 

Country:

China 

Province:

Shaanxi 

City:

Yanan 

单位(医院):

延安大学附属医院 

单位级别:

三级甲等 

Institution
hospital:

Yan 'an University Affiliated Hospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

山东 

市(区县):

济南 

Country:

China 

Province:

Shandong 

City:

Jinan 

单位(医院):

山东中医药大学第二附属医院 

单位级别:

三级甲等 

Institution
hospital:

The Second Affiliated Hospital of Shandong University of Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

治疗有效

指标类型:

主要指标 

Outcome:

Effective 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:

总体症状缓解程度评价

指标类型:

次要指标 

Outcome:

Evaluation of overall symptom relief

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

排便频率

指标类型:

次要指标 

Outcome:

Frequency of defecation

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

腹胀评价(有肠鸣音,伴随排气增多或频繁嗳气)

指标类型:

次要指标 

Outcome:

Abdominal distension (with bowel sounds, accompanied by increased gas or frequent belching)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

排便急迫感评价

指标类型:

次要指标 

Outcome:

Urgency of defecation

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

补救药物使用情况

指标类型:

次要指标 

Outcome:

Use of remedial drugs

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生活质量参数(IBS-QOL量表)

指标类型:

次要指标 

Outcome:

Quality of life (IBS-QOL scale)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

汉密尔顿焦虑抑郁分值的变化

指标类型:

次要指标 

Outcome:

Changes in the score of Hamilton's anxiety and depression

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

菌群和代谢组学变化

指标类型:

次要指标 

Outcome:

Changes of microbiota and metabonomics

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

不良事件

指标类型:

副作用指标 

Outcome:

adverse event

Type:

Adverse events 

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:

副作用指标 

Outcome:

Vital signs

Type:

Adverse events 

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:

副作用指标 

Outcome:

physical examination

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血常规

指标类型:

副作用指标 

Outcome:

Routine blood test

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿常规

指标类型:

副作用指标 

Outcome:

Urine routine

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

大便常规+隐血

指标类型:

副作用指标 

Outcome:

Stool routine + Occult Blood

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肝肾功能

指标类型:

副作用指标 

Outcome:

Function of liver and kidney

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

空腹血糖

指标类型:

副作用指标 

Outcome:

Fasting blood glucose

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心电图

指标类型:

副作用指标 

Outcome:

electrocardiogram

Type:

Adverse events 

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

用于判断纳入排除标准和安全性分析

Fate of sample:

Destruction after use 

Note:

Used to judge the inclusion and exclusion criteria and safety analysis

标本中文名:

尿

组织:

Sample Name:

urine

Tissue:

人体标本去向

使用后销毁 

说明

用于判断纳入排除标准和安全性分析

Fate of sample:

Destruction after use 

Note:

Used to judge the inclusion and exclusion criteria and safety analysis

标本中文名:

大便

组织:

Sample Name:

Stool

Tissue:

人体标本去向

使用后保存 

说明

用于判断纳入排除标准和安全性分析,用于药物疗效的机制探讨

Fate of sample:

Preservation after use 

Note:

Used to judge the inclusion and exclusion criteria and safety analysis and to evaluate the machanism of the drug efficacy

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 years
最大 Max age 65 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):

统计专家根据“临床研究随机化方案”对试验用药进行随机编码。试验用药随机编码为受试者唯一识别码。受试者必须自始至终处于盲态。采用分层区组随机方法。

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

According to the randomization scheme of clinical research, statistical experts randomly coded experimental drugs. The test drug was randomly encoded as the unique identifier of the subjects. The subjects must be in a blind state from beginning to end. The stratif

盲法:

Not stated

Blinding:

Not stated

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

2020年10月1日公开于本网站

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

Open to this website on October 1, 2020

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:

我们设计了纸质的CRF,按照纸质的CRF建设好EDC系统,研究者负责采集每位受试者每次随访的信息至EDC系统中,数据管理人员进行数据管理。

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

We designed the paper CRF and built the EDC system according to the paper CRF,The investigator were responsible for collecting information from each of the subjects every follow-up to the EDC system and data management personnel conduct data management.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2018-08-10
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