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Study on the intestinal microecology with ''Formula Syndrome'' of TCM for diarrehea-predominant pattern irritable bowel syndrome by the technology of metagenomics

注册号：

Registration number：

ITMCTR2100004775

最近更新日期：

Date of Last Refreshed on：

2021-04-23

注册时间：

Date of Registration：

2021-04-23

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

腹泻型肠易激综合征中医方-证-肠道微生态的宏基因学研究

Public title：

Study on the intestinal microecology with ''Formula Syndrome'' of TCM for diarrehea-predominant pattern irritable bowel syndrome by the technology of metagenomics

注册题目简写：

English Acronym：

研究课题的正式科学名称：

腹泻型肠易激综合征中医方-证-肠道微生态的宏基因学研究

Scientific title：

Study on the intestinal microecology with ''Formula Syndrome'' of TCM for diarrehea-predominant pattern irritable bowel syndrome by the technology of metagenomics

研究课题的正式科学名称简写：

Scientific title acronym：

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：

ChiCTR2100045751 ; ChiMCTR2100004775

申请注册联系人：

冯培民

研究负责人：

冯培民

Applicant：

Feng Peimin

Study leader：

Feng Peimin

申请注册联系人电话：

Applicant telephone：

+86 18981885793

研究负责人电话：

Study leader's telephone：

+86 18981885793

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：

fpmvv@126.com

研究负责人电子邮件：

Study leader's E-mail：

fpmvv@126.com

申请单位网址(自愿提供)：

Study leader's 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：

四川省成都市金牛区十二桥路39号

研究负责人通讯地址：

四川省成都市金牛区十二桥路39号

Applicant address：

39 Twelfth Bridge Road, Jinniu District, Chengdu, Sichuan

Study leader's address：

39 Twelfth Bridge Road, Jinniu District, Chengdu, Sichuan

申请注册联系人邮政编码：

Applicant postcode：

610072

研究负责人邮政编码：

Study leader's postcode：

610072

申请人所在单位：

成都中医药大学附属医院

Applicant's institution：

Hospital of Chengdu University of Traditional Chinese Medicine

是否获伦理委员会批准：

Approved by ethic committee：

伦理委员会批件文号：

Approved No. of ethic committee：

2019KL-024

伦理委员会批件附件：

Approved file of Ethical Committee：

View

批准本研究的伦理委员会名称：

四川中医药区域伦理审查委员会；成都中医药大学附属医院伦理委员会

Name of the ethic committee：

Sichuan Regional Ethics Review Committee of Traditional Chinese Medicine; Ethics Committee of Affiliated Hospital of Chengdu University of traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2019/6/12 0:00:00

伦理委员会联系人：

彭顺林

Contact Name of the ethic committee：

Peng Shunlin

伦理委员会联系地址：

四川省成都市金牛区十二桥路39号

Contact Address of the ethic committee：

39 Twelfth Bridge Road, Jinniu District, Chengdu, Sichuan

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：

成都中医药大学

Primary sponsor：

Chengdu University of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

四川省成都市金牛区十二桥路39号

Primary sponsor's address：

39 Twelfth Bridge Road, Jinniu District, Chengdu, Sichuan

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

四川

市(区县)：

成都

Country：

China

Province：

Sichuan

City：

Chengdu

单位(医院)：

成都中医药大学附属医院

具体地址：

金牛区十二桥路39号

Institution
hospital：

Hospital of Chengdu University of Traditional Chinese Medicine

Address：

39 Twelfth Bridge Road, Jinniu District

经费或物资来源：

国家自然科学基金委

Source(s) of funding：

National Natural Science Foundation of China

研究疾病：

腹泻型肠易激综合征

研究疾病代码：

Target disease：

irritable bowel syndrome-Diarrhea

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

析因分组（即根据危险因素或暴露因素分组）

Factorial

研究所处阶段：

Study phase：

探索性研究/预试验

Pilot clinical trial

研究目的：

通过宏基因组测序分析不同患者（用药前后）肠道微生物菌群种类和丰度的变化趋势，找出个体间肠道菌群最突出的差异的代谢途径及信号通路，找出导致这些差异的关键基因；并结合临床实际探讨其表达的关系，有助于早期诊断、判断预后；初步揭示中医方-证-肠道微生态之间的效应关系，初步为该病的微观辨证奠定宏基因组学基础。

Objectives of Study：

Metagenomic sequencing was used to analyze the variety trend and abundance of intestinal microflora in different patients (before and after medication), to find out the metabolic pathway and signal pathway of the most prominent differences in intestinal microflora among individuals, and to find out the key genes leading to these differences; The relationship of its expression was discussed in combination with clinical practice, it is helpful for early diagnosis and prognosis; To reveal the relationship between TCM prescriptions, syndromes and intestinal microecology, and to lay the foundation of metagenomics for the Micro syndrome differentiation of the disease.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

西医纳入标准： 1.符合腹泻型肠易激综合征西医诊断标准者； 2.腹痛强度在过去的24小时中最严重的腹痛评分，每周平均值>=3分（11点疼痛数字等级量表）；同时粪便性状每周至少有2日至少1次粪便性状为Bristol粪便性状量表6型或7型； 3.初始肠易激综合征严重程度（IBS-SSS）评分>75分； 4.年龄在18-65岁之间（包含18周岁及65周岁），性别不限； 5.自愿接受相应治疗，并签署知情同意书； 6.常驻本地，能保证治疗随访，有一定的阅读能力。只有以上入选标准都满足者，才能进入下一步证型筛选。 中医纳入标准，肝郁脾虚证中医证型纳入标准： 主症：1.腹痛即泻，泻后痛减；2.急躁易怒。 次症：1.两胁胀满；2.纳呆；3.身倦乏力。 舌脉：1.舌淡胖，边有齿痕，苔薄白；2.脉弦细。 辨证要求：具备主症2项，加次症2项，及舌脉符合者。 脾虚湿盛证中医证型纳入标准： 主症：1.大便溏泻；2.腹痛隐隐。 次症：1.劳累或受凉后发作或加重；2.神疲倦怠；3.纳呆。 舌脉：1.舌淡，边有齿痕，苔白腻；2.脉虚弱。 辨证要求：具备主症2项，加次症2项，及舌脉符合者。

Inclusion criteria

Western medicine inclusion criteria: 1.Those who met the diagnostic criteria of Western medicine for diarrhea predominant irritable bowel syndrome; 2.The most severe abdominal pain score in the past 24 hours, with a weekly average of >= 3 points (11 point pain digital rating scale); At the same time fecal traits at least 2 days a week at least once fecal traits Bristol fecal traits scale type 6 or 7; 3.IBS-SSS score > 75; 4.The age is between 18 and 65 years old (including 18 and 65 years old), regardless of gender; 5.Voluntary treatment and informed consent were signed; 6.Resident in the local, can ensure treatment follow-up, have a certain reading ability. Only those who meet the above criteria can enter the next stage of syndrome screening. TCM inclusion criteria, liver depression and spleen deficiency syndrome TCM inclusion criteria of the main symptoms: Main symptoms:1.Abdominal pain wants to defecate, and the pain is relieved after defecation; 2.Temper tantrums are easy to be angry. Secondary symptoms:1.Fullness under both flanks; 2.Poor appetite; 3.Exhaustion. Tongue coating pulse:1.The tongue is fat, the tongue color is pale, there are tooth marks on the edge of the tongue, and the tongue coating is thin and white; 2.The pulse string is thin. Dialectical requirements: With 2 main symptoms, 2 secondary symptoms, and tongue and vein in line with. Inclusion Criteria of Spleen Deficiency and Dampness Syndrome in TCM: Main symptoms:1.More stool frequency, stool is not formed; 2.Abdominal dull pain. Secondary diseases:1.Attack or aggravation after exertion or catching cold; 2.Fatigue; 3.Poor appetite. Tongue pulse:1.Pale tongue, teeth marks on the edge of the tongue, white and greasy tongue coating; 2.Weak pulse. Dialectical requirements:With 2 main symptoms, 2 secondary symptoms, and tongue and vein in line with.

排除标准：

西医排除标准： 1.便秘型、混合型、不定型肠易激综合征及其他消化系统器质性病变者，或者其他器质性病变引起腹痛、腹部不适者； 2.经检查证实为感染性腹泻、炎症性肠病、寄生虫感染、大便潜血阳性、结直肠肿瘤、吸收不良综合征、乳糖不耐受（结合病史）以及全身性疾病引起的腹泻； 3.合并有糖尿病、甲状腺功能亢进症，或合并心、脑、肝、肾、造血系统等严重原发疾病者，或者影响其生存的严重疾病者（如肿瘤等），或肝肾功能（BUN、Cr）异常者（ALT、AST>正常值范围上限的1.5倍，Cr>正常值上限），以及有临床意义的心电图异常者； 4.有神经系统疾病及精神病史者； 5.既往有胃肠道手术史者（剖腹产手术及阑尾切除术除外）； 6.正在或者需要继续使用可能影响胃肠动力药物（抗胆碱能药物、5-HT3受体拮抗剂、止泻剂、抑酸剂、促动力药、抗抑郁药、抗焦虑药、肠道菌群调节药等）者，或既往2周内使用其他治疗肠易激综合征的中西药物者； 7.过敏体质，有研究所的相关药物过敏史及严重食物过敏史者； 8.怀疑或者确有酒精、药物滥用史者； 9.妊娠及哺乳期妇女，及近期有妊娠计划者； 10.认知功能障碍，不能给予充分知情同意者； 11.近1个月内参加其他临床试验的患者； 12.研究者认为存在有不适合入选因素的患者。 中医排除标准： 肝郁脾虚证兼夹证排除标准： 湿热头重如裹，胸闷痞闷，口腻，肢体困重或酸痛；黄腻苔。 符合两条者，均不能进入本研究。 脾胃虚寒胃痛绵绵，空腹为甚，得食则缓，喜热喜按，泛吐清水；手足不温，大便多溏。 符合两条者，均不能进入本研究。 气郁化热发热，恶热；口渴喜冷饮，汗多；大便干结或便秘，小便短黄面色赤；舌质红或绛，舌苔黄或灰黑而干燥，脉数有力。 符合两条者，均不能进入本研究。 肾阴虚，腰膝酸痛；眩晕耳鸣；男子遗精；女子月经失调；虚热。 符合两条者，均不能进入本研究。 肾气虚，腰膝酸软，神疲乏力；小便频数而清，或尿后余沥不尽，或遗尿，或夜尿频多，或小便失禁；男子滑精、早泄，女子月经淋漓不尽，或带下清稀量多，或胎动易滑；舌淡，苔白，脉弱。 符合两条者，均不能进入本研究。 肾阳虚，男子阳痿，早泄，精冷，女子宫寒不孕，性欲减退；便泻稀溏，五更泄泻；小便频数、清长，夜尿多；形寒肢冷，腰膝酸冷。 符合两条者，均不能进入本研究。 脾虚湿盛证兼夹证排除标准： 湿热，胸闷不舒，烦渴引饮；口干口苦；黄腻苔。 符合两条者，均不能进入本研究。 脾胃虚寒，胃痛绵绵，空腹为甚，得食则缓，喜热喜按，泛吐清水；手足不温，大便多溏。 符合两条者，均不能进入本研究。 血瘀，面色晦暗，或见赤缕红丝； 舌质暗或有瘀斑；两胁刺痛；女子行经腹痛或经色暗红有块。 符合两条者，均不能进入本研究。 肝郁气滞，胸闷不舒，喜善太息；嗳气频作，心情不畅。 符合两条者，均不能进入本研究。 肾气虚 腰膝酸软，神疲乏力；小便频数而清，或尿后余沥不尽，或遗尿，或夜尿频多，或小便失禁；男子滑精、早泄，女子月经淋漓不尽，或带下清稀量多，或胎动易滑； 舌淡，苔白，脉弱。 符合两条者，均不能进入本研究。 肾阳虚 男子阳痿，早泄，精冷，女子宫寒不孕，性欲减退；便泻稀溏，五更泄泻；小便频数、清长，夜尿多；形寒肢冷，腰膝酸冷。 符合两条者，均不能进入本研究。

Exclusion criteria：

Western medicine exclusion criteria: 1.Constipation type, mixed type, atypical irritable bowel syndrome and other organic diseases of digestive system, or other organic diseases causing abdominal pain and discomfort; 2.It was confirmed by examination as infectious diarrhea, inflammatory bowel disease, parasitic infection, positive fecal occult blood, colorectal tumor, malabsorption syndrome, lactose intolerance (combined with history) and diarrhea caused by systemic diseases; 3.Patients with diabetes mellitus, hyperthyroidism, or severe primary diseases such as heart, brain, liver, kidney, hematopoietic system, or severe diseases affecting their survival (such as tumor), or abnormal liver and kidney functions (BUN, Cr) (alt, AST > 1.5 times of the upper limit of normal range, Cr > the upper limit of normal range), and patients with abnormal ECG of clinical significance; 4.Patients with history of nervous system disease and mental illness; 5.Previous gastrointestinal surgery (except caesarean section and appendectomy); 6.Patients are or need to continue to use drugs that may affect gastrointestinal motility (anticholinergic drugs, 5-HT3 receptor antagonists, antidiarrheal agents, antacids, prokinetic drugs, antidepressants, anxiolytics, intestinal flora regulators, etc.), or those who have used other traditional Chinese and Western drugs for the treatment of irritable bowel syndrome in the past 2 weeks; 7.Allergic constitution, with a history of drug allergy and severe food allergy; 8.Suspect or have a history of alcohol or drug abuse; 9.Pregnant and lactating women, and those with recent pregnancy planning; 10.Cognitive impairment, can not give full informed consent; 11.Patients who participated in other clinical trials in the past one month; 12.The researchers believe that there are patients who are not suitable for inclusion. TCM inclusion criteria: Exclusion criteria of combined syndrome of liver depression and spleen deficiency: Damp-heat, heavy head, chest distress, greasy mouth, limb drowsiness or soreness; yellow and greasy tongue coating. Patients met the above two items could not be included in this study. Spleen and stomach deficiency cold syndrome, stomach dull pain, fasting aggravated, relieved after eating, like to press, vomiting water; hands and feet are not warm, stool is not formed. Patients met the above two items could not be included in this study. Stagnation of liver-qi, fever, aversion to fever; thirst like to drink cold water, sweating; dry stool or constipation, small urine volume color yellow, red complexion; purple red tongue, yellow or grayish black tongue coating and dry, increased pulse rate, strong pulsation. Patients met the above two items could not be included in this study. Kidney yin deficiency, waist and knee pain; vertigo and tinnitus; male spermatorrhea; female menstrual disorders; fever due to yin deficiency. Patients met the above two items could not be included in this study. Kidney deficiency, soreness and weakness of waist and knees, exhaustion; more times of urination, clear urine, or incomplete emptying, or enuresis, or more times of urination at night, or urinary incontinence; men slippery sperm, premature ejaculation, women with long duration of menstruation, or leucorrhea, or easy abortion of the fetus; pale tongue, white tongue coating, weak pulse. Patients met the above two items could not be included in this study. Kidney yang deficiency, male impotence, premature ejaculation, cold semen, women are not easy to become pregnant, loss of libido; stool frequency is not formed, defecation in the early morning; urine frequency, urine color is light, increased nocturia; cold limbs, waist and knee cold pain. Patients met the above two items could not be included in this study. Exclusion criteria for combined syndrome of spleen deficiency and dampness syndrome: Damp-heat, chest distress, irritability, thirst; dry mouth, bitter taste; yellow and greasy tongue coating. Patients met the above two items could not be included in this study. Spleen and stomach deficiency cold syndrome, stomach dull pain, fasting aggravated, relieved after eating, like to press, vomiting water; hands and feet are not warm, stool is not formed. Patients met the above two items could not be included in this study. Blood stasis, dull complexion, dark tongue or ecchymosis; two flank tingling; women feel abdominal pain during menstruation, menstrual color dark red with blood clots. Patients met the above two items could not be included in this study. Liver qi stagnation, chest discomfort, often sigh; often belching, depressed mood. Patients met the above two items could not be included in this study. Kidney deficiency, soreness and weakness of waist and knees, exhaustion; more times of urination, clear urine, or incomplete emptying, or enuresis, or more times of urination at night, or urinary incontinence; men slippery sperm, premature ejaculation, women with long duration of menstruation, or leucorrhea, or easy abortion of the fetus; pale tongue, white tongue coating, weak pulse. Patients met the above two items could not be included in this study. Kidney yang deficiency, male impotence, premature ejaculation, cold semen, women are not easy to become pregnant, loss of libido; stool frequency is not formed, defecation in the early morning; urine frequency, urine color is light, increased nocturia; cold limbs, waist and knee cold pain. Patients met the above two items could not be included in this study.

研究实施时间：

Study execute time：

从From 2021-05-01

至To      2022-12-31

征募观察对象时间：

Recruiting time：

从From 2021-05-01

至To      2021-12-31

干预措施：

Interventions：

组别：

脾虚湿盛证组

样本量：

50

Group：

Spleen deficiency and dampness syndrome group

Sample size：

干预措施：

痛泻要方或参苓白术散免煎颗粒剂

干预措施代码：

Intervention：

Tongxie Yaofang or Shenling Baizhu Powder non-decocted granules

Intervention code：

组别：

肝郁脾虚证组

样本量：

50

Group：

Syndrome of liver depression and spleen deficiency group

Sample size：

干预措施：

痛泻要方或参苓白术散免煎颗粒剂

干预措施代码：

Intervention：

Tongxie Yaofang or Shenling Baizhu Powder non-decocted granules

Intervention code：

样本总量 Total sample size ： 100

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

四川

市(区县)：

成都

Country：

China

Province：

Sichuan

City：

Chengdu

单位(医院)：

成都中医药大学附属医院

单位级别：

三级甲等

Institution/hospital：

Hospital of Chengdu University of Traditional Chinese Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

腹泻型肠易激综合征患者生活质量调查表（IBS-QOL）

指标类型：

次要指标

Outcome：

Quality of Life Questionnaire for Patients with Diarrheal Irritable Bowel Syndrome (IBS-QOL)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

腹泻型肠易激综合征症状严重程度（IBS-SSS）评分

指标类型：

主要指标

Outcome：

Symptom severity of diarrheal irritable bowel syndrome (IBS-SSS) score

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

明显减轻情况

指标类型：

主要指标

Outcome：

Significant mitigation

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

患者排便症状情况（日记卡）

指标类型：

次要指标

Outcome：

Patient's symptoms of defecation (diary card)

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：

faeces

Tissue：

人体标本去向

其它

说明

Fate of sample 

Others

Note：

征募研究对象情况：

正在进行

Recruiting

年龄范围：

最小 18 岁
Min age years
最大 65 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

男女均可

Both

随机方法（请说明由何人用什么方法产生随机序列）：

本试验为非随机对照试验。

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

This study was a non-randomized controlled trial.

盲法：

N/A

Blinding：

N/A

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）：

2022年6月在中国临床试验注册中心原始数据共享平台（IPD 共享平台）上公开。

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

It will be published on the original data sharing platform (IPD sharing platform) of China clinical trial registry in June 2022.

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：

1.腹泻型肠易激综合征中医方-证-肠道微生态的宏基因学研究病例报告表； 2.电子采集和管理系统：Oracle Health Sciences Clintrial。

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

1.Case report of macrogenetic study on traditional Chinese medicine formula syndrome intestinal microecology of diarrhea predominant irritable bowel syndrome; 2.Electronic collection and management system: Oracle Health Sciences Clinical.

数据管理委员会：

Data Managemen Committee：

有

Yes

研究计划书或研究结果报告发表信息
（杂志名称、期、卷、页，时间；或网址）：

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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