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：	ChiCTR2400084518
最近更新日期： Date of Last Refreshed on：	2024-05-20 10:03:58
注册时间： Date of Registration：	2024-05-20 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	基于口腔-肠道菌群探讨帕金森病流涎的机制及综合管理
Public title：	Exploring the mechanism and comprehensive management of salivation in Parkinson's disease based on oral gut microbiota
注册题目简写：
English Acronym：
研究课题的正式科学名称：	基于口腔-肠道菌群探讨帕金森病流涎的机制及综合管理
Scientific title：	Exploring the mechanism and comprehensive management of salivation in Parkinson's disease based on oral gut microbiota
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：	韩冰毓	研究负责人：	脱厚珍
Applicant：	Bingyu Han	Study leader：	Houzhen Tuo
申请注册联系人电话： Applicant telephone：	+86 136 2126 6561	研究负责人电话： Study leader's telephone：	+86 136 8362 8005
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：	hanbingyu@bjmu.edu.cn	研究负责人电子邮件： Study leader's E-mail：	tuohzh@sina.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：	北京市西城区永安路95号	研究负责人通讯地址：	北京市西城区永安路95号
Applicant address：	95 Yong'an Road, Xicheng District, Beijing	Study leader's address：	95 Yong'an Road, Xicheng District, Beijing
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：	首都医科大学附属北京友谊医院
Applicant's institution：	Beijing Friendship Hospital Affiliated to Capital Medical University
研究负责人所在单位：	首都医科大学附属北京友谊医院
Affiliation of the Leader：	Beijing Friendship Hospital Affiliated to Capital Medical University

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：	2024-P2-119-01	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：	首都医科大学附属北京友谊医院生命伦理委员会
Name of the ethic committee：	Bioethics Committee of Beijing Friendship Hospital, Capital Medical University
伦理委员会批准日期： Date of approved by ethic committee：	2024-04-29 00:00:00
伦理委员会联系人：	李悦
Contact Name of the ethic committee：	Yue Li
伦理委员会联系地址：	北京市西城区永安路95号
Contact Address of the ethic committee：	95 Yong'an Road, Xicheng District, Beijing
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 10 6313 9047	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：

首都医科大学附属北京友谊医院

Primary sponsor：

Beijing Friendship Hospital, Capital Medical University

研究实施负责（组长）单位地址：

北京市西城区永安路95号

Primary sponsor's address：

95 Yong'an Road, Xicheng District, Beijing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	北京	市(区县)：
Country：	China	Province：	Beijing	City：
单位(医院)：	北京友谊医院	具体地址：	北京市西城区永安路95号
Institution hospital：	Beijing Friendship Hospital, Capital Medical University	Address：	95 Yong'an Road, Xicheng District, Beijing

经费或物资来源：

自筹

Source(s) of funding：

raise independently

研究疾病：

帕金森病

Target disease：

Parkinson's disease

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

探索性研究/预试验

Study phase：

0

研究设计：

横断面

Study design：

Cross-sectional

研究目的：

1.入组原发性帕金森病合并流涎患者（PD-流涎）、原发性帕金森病不合并流涎患者（PD-非流涎）和健康对照者，使用核素显像技术探究不同人群中唾液腺摄取率差异，比较不同人群中唾液分泌量，以及唾液腺的核素分布，探讨唾液腺分泌功能在流涎中的作用； 2.收集活检的唾液腺组织以及无菌唾液和粪便标本，进行微生物宏基因测序，明确唾液中的菌群丰度，并进一步明确唾液腺中是否存在与流涎相关的定植菌，进一步探讨PD流涎的机制。

Objectives of Study：

1. Patients with primary Parkinson's disease combined with salivation (PD salivation), patients with primary Parkinson's disease without salivation (PD non salivation), and healthy controls were enrolled. Radionuclide imaging technology was used to explore the differences in salivary gland uptake rates among different populations, compare the amount of saliva secretion and the distribution of salivary glands in different populations, and explore the role of salivary gland secretion function in salivation; 2. Collect biopsy salivary gland tissue as well as sterile saliva and fecal samples, perform microbial metagenomic sequencing, clarify the abundance of microbial communities in saliva, and further clarify whether there are colonizing bacteria related to salivation in salivary glands, further exploring the mechanism of PD salivation.

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. Selection criteria for PD salivation patients:
1) Age range from 40 to 85 years old, regardless of gender;
2) Patients with primary Parkinson's disease meet the clinical diagnostic criteria for Parkinson's disease MDS (2016);
3) The score for item 2.6 in the second part of UPDRS is 1-4 points;
4) The motor and salivation symptoms of Parkinson's disease were stable in the first month before enrollment, and there was no adjustment in medication for all Parkinson's diseases in the first month before enrollment; Two weeks prior to enrollment, no anticholinergic drugs such as bromobistigmine, dihydroergot mesylate, or atropine were taken, and no drugs such as botulinum toxin were injected.
5) No PPI, antibiotics, probiotics or prebiotics were used for the first 2 months before enrollment. If used, a 2-month washout period should be carried out;
6) The Mini Mental State Examination (MMSE) scores>24 points. Hamilton Depression Scale score<17, Anxiety Scale score<14;
7) Understand and agree to comply with the research protocol, agree to be enrolled, and sign an informed consent form.
2. Selection criteria for PD non salivation patients:
1) Age range from 40 to 85 years old, regardless of gender;
2) Patients with primary Parkinson's disease meet the clinical diagnostic criteria for Parkinson's disease MDS (2016);
3) The score for item 2.6 in the second part of UPDRS is 0;
4) The motor and salivation symptoms of Parkinson's disease were stable in the first month before enrollment, and there was no adjustment in medication for all Parkinson's diseases in the first month before enrollment; Two weeks prior to enrollment, no anticholinergic drugs such as bromobistigmine, dihydroergot mesylate, or atropine, as well as injections of botulinum toxin, were taken.
5) Parkinson's motor symptoms were stable one month before enrollment, and there was no adjustment in medication for all Parkinson's diseases in the month before enrollment;
6) No PPI, antibiotics, probiotics or prebiotics were used for the first 2 months before enrollment. If used, a 2-month washout period should be carried out;
7) The Mini Mental State Examination (MMSE) scores>24 points. Hamilton Depression Scale score<17, Anxiety Scale score<14;
8) Understand and agree to comply with the research protocol, agree to be enrolled, and sign an informed consent form.
3. Inclusion criteria for healthy subjects:
1) Age range from 40 to 85 years old, age and gender matched with the above two groups of patients;
2) The Mini Mental State Examination (MMSE) scores>24 points. Hamilton Depression Scale score<17, Anxiety Scale score<14;
3) Before enrollment, no probiotics, prebiotics, or antibiotics were used for treatment. If used, a 2-month washout period should be followed.
4) Understand and agree to comply with the research protocol, agree to be enrolled, and sign an informed consent form.

排除标准：

1.PD-流涎患者排除标准： 1）帕金森叠加综合征和继发性帕金森综合征, 如多系统萎缩，进行性核上性麻痹，皮质底节变性，路易体痴呆，血管性帕金森综合征，脑炎后帕金森综合征，或其他任何非原发性帕金森病； 2）入组前有长期吸烟史； 3）入组前1月帕金森病用药有调整；入组前1月内服用阿托品等抗胆碱类药物以及等注射肉毒素等药物； 4）有可能影响唾液分泌功能的唾液相关疾病病史，包括但不限于以下疾病：原发性或继发性Sjögren综合征和结节病，或器官功能障碍，如唾液石症； 5）严重心血管疾病（如美国心脏病协会心功能分级为Ⅲ-Ⅳ级的充血性心力衰竭，6 月内的心肌梗死史等）； 6）严重肝肾功能障碍； 7）妊娠及哺乳期妇女或 40-60 岁孕龄期女性 HCG 阳性者； 8）已知对奥美拉唑肠溶胶囊或其辅料等过敏者； 9）有药物滥用史或酒精依赖史者； 10）入组时正在参加其他临床试验者； 11）拒绝入组以及不能配合研究者；研究者判断为不适合入组的患者。 2.PD-非流涎患者排除标准： 1）有帕金森病运动症状，符合帕金森综合征诊断者，纳入 PD-流涎组；帕金森叠加综合征和继发性帕金森综合征, 如多系统萎缩，进行性核上性麻痹，皮质底节变性，路易体痴呆，血管性帕金森综合征，脑炎后帕金森综合征，或其他任何非原发性帕金森病； 2）入组前有长期吸烟史； 3）入组前 1 月帕金森病用药有调整；入组前1月内服用阿托品等抗胆碱类药物以及等注射肉毒素等药物； 4）有可能影响唾液分泌功能的唾液相关疾病病史，如Sjögren综合征和结节病，或器官功能障碍，如唾液石症； 5）严重心血管疾病（如美国心脏病协会心功能分级为Ⅲ-Ⅳ级的充血性心力衰竭，6 月内的心肌梗死史等）； 6）严重肝肾功能不全； 7）妊娠及哺乳期妇女或 40-60 岁孕龄期女性 HCG 阳性者； 8）已知对奥美拉唑肠溶胶囊或其辅料等过敏者； 9）有药物滥用史或酒精依赖史者； 10）入组时正在参加其他临床试验者； 11）拒绝入组以及不能配合研究者；研究者判断为不适合入组的患者。 3.健康受试者排除标准：同 PD-流涎患者排除标准以及PD-非流涎患者排除标准。

Exclusion criteria：

1. Exclusion criteria for PD salivation patients: 1) Parkinson's superimposition syndrome and secondary Parkinson's syndrome, such as multiple system atrophy, progressive supranuclear palsy, cortical basal ganglia degeneration, Louis body dementia, vascular Parkinson's syndrome, post encephalitis Parkinson's syndrome, or any other non primary Parkinson's disease; 2) Long term smoking history before enrollment; 3) The medication for Parkinson's disease was adjusted one month before enrollment; Taking anticholinergic drugs such as atropine and injecting botulinum toxin within one month before enrollment; 4) A history of salivary related diseases that may affect salivary secretion function, including but not limited to the following diseases: primary or secondary Sj ö gren syndrome and sarcoidosis, or organ dysfunction, such as salivary stones; 5) Severe cardiovascular diseases (such as congestive heart failure classified as Grade III-IV by the American Heart Association, history of myocardial infarction within 6 months, etc.); 6) Severe liver and kidney dysfunction; 7) Pregnant and lactating women or pregnant women aged 40-60 who are HCG positive; 8) Individuals who are known to be allergic to omeprazole enteric coated capsules or their excipients; 9) Individuals with a history of drug abuse or alcohol dependence; 10) Individuals who were participating in other clinical trials at the time of enrollment; 11) Refusal to join and inability to cooperate with researchers; The researchers determined that patients were not suitable for enrollment. 2. Exclusion criteria for PD non salivation patients: 1) Individuals with Parkinson's disease motor symptoms who meet the diagnosis of Parkinson's syndrome are included in the PD salivation group; Parkinson's superimposition syndrome and secondary Parkinson's syndrome, such as multiple system atrophy, progressive supranuclear palsy, cortical basal ganglia degeneration, Louis body dementia, vascular Parkinson's syndrome, post encephalitis Parkinson's syndrome, or any other non primary Parkinson's disease; 2) Long term smoking history before enrollment; 3) The medication for Parkinson's disease was adjusted one month before enrollment; Taking anticholinergic drugs such as atropine and injecting botulinum toxin within one month before enrollment; 4) A history of salivary related diseases that may affect salivary secretion function, such as Sj ö gren syndrome and sarcoidosis, or organ dysfunction, such as salivary stones; 5) Severe cardiovascular diseases (such as congestive heart failure classified as Grade III-IV by the American Heart Association, history of myocardial infarction within 6 months, etc.); 6) Severe liver and kidney dysfunction; 7) Pregnant and lactating women or pregnant women aged 40-60 who are HCG positive; 8) Individuals who are known to be allergic to omeprazole enteric coated capsules or their excipients; 9) Individuals with a history of drug abuse or alcohol dependence; 10) Individuals who were participating in other clinical trials at the time of enrollment; 11) Refusal to join and inability to cooperate with researchers; The researchers determined that patients were not suitable for enrollment. 3. Exclusion criteria for healthy subjects: the same as the exclusion criteria for PD salivation patients and PD non salivation patients.

研究实施时间：

Study execute time：

从 From 2024-05-20 00:00:00至 To 2026-05-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2024-05-20 00:00:00 至 To 2026-05-31 00:00:00

干预措施：

Interventions：

组别：	帕金森流涎患者组	样本量：	30
Group：	Parkinson's salivation group	Sample size：	30
干预措施：	无	干预措施代码：
Intervention：	None	Intervention code：

组别：	帕金森非流涎组	样本量：	30
Group：	Parkinson's non salivation group	Sample size：	30
干预措施：	无	干预措施代码：
Intervention：	None	Intervention code：

组别：	健康受试组	样本量：	30
Group：	Healthy trial group	Sample size：	30
干预措施：	无	干预措施代码：
Intervention：	None	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	北京	市(区县)：
Country：	China	Province：	Beijing	City：
单位(医院)：	首都医科大学附属北京友谊医院	单位级别：	三甲
Institution hospital：	Beijing Friendship Hospital Affiliated to Capital Medical University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	静息唾液流率	指标类型：	主要指标
Outcome：	Resting saliva flow rate	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	唾液腺显像	指标类型：	次要指标
Outcome：	Salivary gland imaging	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	唾液生化检验	指标类型：	次要指标
Outcome：	Salivary biochemical test	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	唾液菌群丰度	指标类型：	次要指标
Outcome：	Abundance of salivary microbiota	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	粪便菌群丰度	指标类型：	次要指标
Outcome：	Abundance of fecal microbiota	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	统一PD评定量表(UPDRS)	指标类型：	次要指标
Outcome：	Unified PD Rating Scale (UPDRS)	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	改良Hoehn and Yahr (H&Y)分期	指标类型：	次要指标
Outcome：	Improved Hoehn and Yahr (H&Y) staging	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	汉密尔顿抑郁评定量表(HAMD)	指标类型：	次要指标
Outcome：	Hamilton Depression Rating Scale (HAMD)	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	简易精神状态量表（MMSE）	指标类型：	次要指标
Outcome：	Mini Mental State Scale (MMSE)	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	流涎严重程度和频率量表（DSFS）	指标类型：	次要指标
Outcome：	Salivation Severity and Frequency Scale (DSFS)	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	Cleveland便秘评分	指标类型：	次要指标
Outcome：	Cleveland Constipation Score	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	胃肠道症状评定量表	指标类型：	次要指标
Outcome：	Gastrointestinal Symptom Assessment 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：	临床疗效总评量表	指标类型：	次要指标
Outcome：	Clinical efficacy evaluation 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：	唾液腺活检	指标类型：	次要指标
Outcome：	Salivary gland biopsy	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	汉密尔顿焦虑评定量表(HAMA)	指标类型：	次要指标
Outcome：	Hamilton Anxiety Rating Scale (HAMA)	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：	唾液	组织：
Sample Name：	Saliva	Tissue：
人体标本去向	使用后保存	说明
Fate of sample：	Preservation after use	Note：

标本中文名：	粪便	组织：
Sample Name：	Feces	Tissue：
人体标本去向	使用后保存	说明
Fate of sample：	Preservation after use	Note：

标本中文名：	唾液腺组织	组织：
Sample Name：	Salivary gland tissue	Tissue：
人体标本去向	使用后保存	说明
Fate of sample：	Preservation 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	40	岁 years
最大 Max age	85	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）：

无

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

None

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：	无
Blinding：	None

是否共享原始数据： IPD sharing	否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）：	无
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	None
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：	CRF
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	CRF
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2024-05-20 10:03:54