Traditional Chinese medicine Dachaihu decoction ameliorates abnormal behavior through regulating gut microbiota and metabolites in children with ASD

注册号:

Registration number:

ITMCTR2024000378

最近更新日期:

Date of Last Refreshed on:

2024-09-04

注册时间:

Date of Registration:

2024-09-04

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

基于“微生物-肠-脑轴”理论探究大柴胡汤干预减轻儿童孤独症谱系障碍的效果和分子机制

Public title:

Traditional Chinese medicine Dachaihu decoction ameliorates abnormal behavior through regulating gut microbiota and metabolites in children with ASD

注册题目简写:

English Acronym:

研究课题的正式科学名称:

基于“微生物-肠-脑轴”理论探究大柴胡汤干预减轻儿童孤独症谱系障碍的效果和分子机制

Scientific title:

Traditional Chinese medicine Dachaihu decoction ameliorates abnormal behavior through regulating gut microbiota and metabolites in children with ASD

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:

申请注册联系人:

冯朋雅

研究负责人:

冯朋雅

Applicant:

Pengya Feng

Study leader:

Pengya Feng

申请注册联系人电话:

Applicant telephone:

18719816628

研究负责人电话:

Study leader's telephone:

18719816628

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:

fengpy@zzu.edu.cn

研究负责人电子邮件:

Study leader's E-mail:

fengpy@zzu.edu.cn

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:

郑州市二七区康复前街3号

研究负责人通讯地址:

郑州市二七区康复前街3号

Applicant address:

Kangfu Qian Road 3, Erqi District, Zhengzhou City

Study leader's address:

Kangfu Qian Road 3, Erqi District, Zhengzhou City

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:

郑州大学第五附属医院

Applicant's institution:

The Fifth Affiliated Hospital of Zhengzhou University

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:

KY2023077

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:

郑州大学第五附属医院伦理委员会

Name of the ethic committee:

The Ethics of Committee of the Fifth Affiliated Hospital of Zhengzhou University

伦理委员会批准日期:

Date of approved by ethic committee:

2023/8/11 0:00:00

伦理委员会联系人:

张小娟

Contact Name of the ethic committee:

Xiaojuan Zhang

伦理委员会联系地址:

河南省郑州市二七区二七区康复前街3号

Contact Address of the ethic committee:

Kangfu Qian Road 3, Erqi District, Zhengzhou City

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 371 6128 5376

伦理委员会联系人邮箱:

Contact email of the ethic committee:

wfyllwyh@163.com

研究实施负责(组长)单位:

郑州大学第五附属医院

Primary sponsor:

The Fifth Affiliated Hospital of Zhengzhou University

研究实施负责(组长)单位地址:

河南省郑州市二七区二七区康复前街3号

Primary sponsor's address:

Kangfu Qian Road 3, Erqi District, Zhengzhou City

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

河南

市(区县):

郑州

Country:

China

Province:

Henan

City:

Zhengzhou

单位(医院):

郑州大学第五附属医院

具体地址:

河南省郑州市二七区康复前街3号

Institution
hospital:

The Fifth Affiliated Hospital of Zhengzhou University

Address:

Kangfu Qian Road 3, Erqi District, Zhengzhou City

经费或物资来源:

河南省科技厅

Source(s) of funding:

Henan Provincial Science and Technology Department

研究疾病:

孤独症谱系障碍

研究疾病代码:

Target disease:

ASD

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段:

Study phase:

探索性研究/预试验

Pilot clinical trial

研究目的:

本项目拟以肠道微生物为潜在靶点,探究中药经方大柴胡汤和肠道菌群相互作用减轻孤独症的临床效果及作用机制,为孤独症从胃肠道论治探索理论依据,以提高中药治疗孤独症的有效性和证据级别,并以期为孤独症的临床治疗提供理论依据与指导意义。

Objectives of Study:

This project intends to take gut microbiota as potential targets to explore the clinical effects and mechanisms of interaction between the classical Chinese medicine formula of Dachaihu Decoction and intestinal flora in alleviating autism, so as to provide theoretical basis for the treatment of autism from the gastrointestinal tract, improve the effectiveness and evidence level of traditional Chinese medicine in the treatment of autism, and provide theoretical basis and guidance for the clinical treatment of autism.

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. 年龄2-6岁; 2. 监护人充分了解课题研究内容并自愿签署知情同意书; 3. 符合DSM-5、ADI-R、ADOS-2,经具有临床诊断资质神经心理医生确诊为孤独症的患儿; 4. 研究前未接受过任何康复治疗的患儿; 5. 治疗过程中均接受传统康复训练(例如:应用行为分析、结构化教学法、感觉统合训练等)和中西医康复治疗(例如:TMS、TDCS、针灸等)的患儿。

Inclusion criteria

1. Age 2-6 years old; 2. The guardian fully understands the research content of the project and voluntarily signs the informed consent form; 3. Children with autism who meet DSM-5, ADI-R, ADOS-2 and have been diagnosed with autism by a neuropsychologist with clinical diagnosis qualifications; 4. Children who have not received any rehabilitation treatment before the study; 5. Children who have received traditional rehabilitation training (e.g., applied behavior analysis, structured teaching methods, sensory integration training, etc.) and traditional Chinese and Western medicine rehabilitation (e.g., TMS, TDCS, acupuncture, etc.) during the treatment.

排除标准:

1. 治疗过程中均接受传统康复训练(例如:应用行为分析、结构化教学法、感觉统合训练等)和中西医康复治疗(例如:TMS、TDCS、针灸等)的患儿; 2. 研究前3个月内服用过可能直接影响肠道菌群的药物,中药汤剂、抗生素、益生菌、其他西药(如利培酮和阿立哌唑等)等药物; 3. 研究期间服用中药汤剂以外可能直接影响肠道菌群的药物,抗生素、益生菌、其他西药(如利培酮和阿立哌唑等)等药物。

Exclusion criteria:

1. Children who have received traditional rehabilitation training (e.g., applied behavior analysis, structured teaching methods, sensory integration training, etc.) and traditional Chinese and Western medicine rehabilitation (e.g., TMS, TDCS, acupuncture, etc.) during the treatment process; 2. Children who have taken drugs that may directly affect the intestinal flora within 3 months before the study, such as traditional Chinese medicine decoction, antibiotics, probiotics, other western medicines (such as risperidone and aripiprazole, etc.); 3. Children who have drugs other than traditional Chinese medicine decoction that may directly affect the intestinal flora, such as antibiotics, probiotics, other western medicines (such as risperidone and aripiprazole, etc.) during the study period .

研究实施时间:

Study execute time:

From 2024-10-01

To      2025-10-01

征募观察对象时间:

Recruiting time:

From 2024-10-01

To      2025-10-01

干预措施:

Interventions:

组别:

对照组

样本量:

50

Group:

Baseline

Sample size:

干预措施:

整个实验过程中采用传统康复训练和中西医结合治疗,并在3个时间点收集孤独症的相关标本和指标,分别是入院时,干预3个月后,和干预6个月后

干预措施代码:

Intervention:

During the whole trial, the children were treated with traditional rehabilitation training and integrated traditional Chinese and western rehabilitation treatment, and the related samples and indicators of autism were collected at three time points: admission, 3 months and 6 months after intervention

Intervention code:

组别:

大柴胡汤组

样本量:

50

Group:

DCH

Sample size:

干预措施:

整个实验过程中采用大柴胡汤+传统康复训练和中西医结合治疗,并分别在干预3个月,和干预6个月后收集孤独症的相关标本和指标

干预措施代码:

Intervention:

During the whole trial, the children were treated with DCHD treatment and traditional rehabilitation training integrated traditional Chinese and western rehabilitation treatment, and the related samples and indicators of autism were collected after 3 months and 6 months of intervention, respectively

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):

河南

市(区县):

郑州

Country:

China

Province:

Henan

City:

Zhengzhou

单位(医院):

郑州大学第五附属医院

单位级别:

三甲

Institution/hospital:

The Fifth Affiliated Hospital of Zhengzhou University

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

粪便基因组

指标类型:

主要指标

Outcome:

Metagenome of Feces

Type:

Primary 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

指标类型:

主要指标

Outcome:

Metabolome of serum

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

白介素6

指标类型:

附加指标

Outcome:

IL-6

Type:

Additional indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

孤独症行为检查量表

指标类型:

主要指标

Outcome:

ABC

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胃肠电

指标类型:

次要指标

Outcome:

EGG

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

孤独症诊断观察量表

指标类型:

主要指标

Outcome:

ADOS

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

粪便宏基因组

指标类型:

主要指标

Outcome:

Metagenome of Feces

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

粪便代谢组

指标类型:

主要指标

Outcome:

Metabolome of Feces

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

谷丙转氨酶

指标类型:

副作用指标

Outcome:

ALT

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

近红外光谱成像

指标类型:

次要指标

Outcome:

fNIRS

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

精神障碍诊断与统计手册

指标类型:

主要指标

Outcome:

DSM-5

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

食物不耐受

指标类型:

次要指标

Outcome:

Food Intolerance

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

孤独症诊断访谈量表

指标类型:

主要指标

Outcome:

ADI-R

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

谷草转氨酶

指标类型:

副作用指标

Outcome:

AST

Type:

Adverse events

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿液代谢组

指标类型:

附加指标

Outcome:

Metabolome of Urine

Type:

Additional indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

白介素8

指标类型:

附加指标

Outcome:

IL-8

Type:

Additional 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:

尿液

组织:

Sample Name:

Urine

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:

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:

征募研究对象情况:

尚未开始

Not yet recruiting

年龄范围:

最小 2
Min age years
最大 6
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):

在整个研究中,符合纳入标准的受试者由管床大夫负责,随后由管床大夫按照受试者入选的先后顺序,根据预定的随机方案通过查阅随机对照表产生,分配入试验组或对照组。

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

In the whole study, the subjects who met the inclusion criteria were in charge of the physican, and then the physican was selected according to the order of the subjects' selection, according to the predetermined randomization protocol, by consulting the randomization control table, and assigned to the experimental group or the control group.

盲法:

所有病人及所有参与治疗或临床评定的大夫及研究人员均不知道谁接受的是何种处理包括挑选合格病人、疗效评价或按照设计方案评价患者依从性。

Blinding:

None of the patients and any of the physicians and researchers involved in the treatment or clinical evaluation were aware of who was receiving what treatment, including the selection of qualified patients, evaluation of efficacy, or evaluation of patient compliance according to the design protocol.

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):

文章发表

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

Article publication

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 Form

数据管理委员会:

Data Managemen Committee:

暂未确定

Not yet

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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