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：	ChiCTR2400090472
最近更新日期： Date of Last Refreshed on：	2024-09-30 15:35:24
注册时间： Date of Registration：	2024-09-30 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	儿童过敏性疾病免疫力解码队列研究
Public title：	Immune System Decoding in Children with Allergic Diseases: A Cohort Study
注册题目简写：
English Acronym：
研究课题的正式科学名称：	儿童过敏性疾病免疫力解码队列研究
Scientific title：	Immune System Decoding in Children with Allergic Diseases: A Cohort Study
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：	郭赟	研究负责人：	郭赟
Applicant：	Guo Yun	Study leader：	Yun Guo
申请注册联系人电话： Applicant telephone：	+86 15852730675	研究负责人电话： Study leader's telephone：	+86 510 85350591
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：	guoyun@njmu.edu.cn	研究负责人电子邮件： Study leader's E-mail：	lu-02cy@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：	江苏省无锡市清扬路299-1号	研究负责人通讯地址：	江苏省无锡市梁溪区清扬路299-1号
Applicant address：	299-1 Qingyang Road, Liangxi District, Wuxi, Jiangsu, China	Study leader's address：	299-1 Qingyang Road, Liangxi District, Wuxi, Jiangsu, 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：	无锡市儿童医院
Applicant's institution：	Wuxi Children's Hospital
研究负责人所在单位：	无锡市儿童医院
Affiliation of the Leader：	Wuxi Children's Hospital

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：	WXCH2024-09-112	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：	无锡市儿童医院医学伦理委员会
Name of the ethic committee：	Wuxi Children's Hospital Medical Ethics Committee
伦理委员会批准日期： Date of approved by ethic committee：	2024-09-30 00:00:00
伦理委员会联系人：	成吉华
Contact Name of the ethic committee：	cheng jihua
伦理委员会联系地址：	江苏省无锡市梁溪区清扬路299-1号
Contact Address of the ethic committee：	299-1 Qingyang Road, Liangxi District, Wuxi, Jiangsu, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 510 85350613	伦理委员会联系人邮箱： Contact email of the ethic committee：	cjhtcm@126.com

研究实施负责（组长）单位：

无锡市儿童医院

Primary sponsor：

Wuxi Children's Hospital

研究实施负责（组长）单位地址：

江苏省无锡市梁溪区清扬路299-1号

Primary sponsor's address：

299-1 Qingyang Road, Liangxi District, Wuxi, Jiangsu, 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)：	江苏	市(区县)：
Country：	China	Province：	Jiangsu	City：
单位(医院)：	无锡市儿童医院	具体地址：	江苏省无锡市梁溪区清扬路299-1号
Institution hospital：	Wuxi Children's Hospital	Address：	299-1 Qingyang Road, Liangxi District, Wuxi, Jiangsu, China

经费或物资来源：

国家自然科学基金

Source(s) of funding：

National Natural Science Foundation of China

研究疾病：

过敏性鼻炎、过敏性哮喘

Target disease：

Allergic Rhinitis, Allergic Asthma

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：

其它

Study phase：

N/A

研究设计：

队列研究

Study design：

Cohort study

研究目的：

开发一套简易的儿童过敏性鼻炎和哮喘免疫力评估量表，以便快速界定儿童在健康与过敏状态下的免疫级别，为评估儿童免疫状况提供创新的评级方法。借助流行病学研究、免疫水平评价和针对性的治疗措施，有效预防和治理儿童过敏性疾病，以提升患儿的生活质量并减轻社会医疗压力。

Objectives of Study：

Develop a simple scale for assessing the immune status of children with allergic rhinitis and asthma, designed to quickly determine the immune level of children in both healthy and allergic states. This innovative rating method aims to provide an assessment tool for children's immune conditions. By leveraging epidemiological studies, immune level evaluations, and targeted treatment measures, effectively prevent and manage childhood allergic diseases, thereby improving the quality of life for pediatric patients and reducing societal medical burden.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

过敏性鼻炎的疾病组： 1.	年龄： 2周岁至6周岁（含）。 2.	诊断依据： 具有过敏性鼻炎的明确诊断。 3.	临床症状： 出现以下症状中的至少两项，且每日症状持续或累计超过1小时： 3.1鼻塞：间歇性或持续性，可影响进食或睡眠。 3.2 流涕：大量清水样涕，可能伴有刺激性咳嗽 3.3鼻痒：异物感或蚁行感，频繁揉鼻。 3.4喷嚏：每天数次阵发性发作，每次多于3个。 4.	体征： 包括鼻黏膜苍白、水肿、鼻腔水样分泌物等。 5.	特殊体征： 可能出现变应性黑眼圈、Dennie Morgan线、变应性皱褶、唇上摩擦痕。 6.	皮肤点刺试验： 对于3岁以上的儿童，至少一种变应原的皮肤点刺试验阳性；若无此检测结果，以临床症状为主。 7.	血清IgE检测： 过敏原sIgE定量检测为阳性。

过敏性鼻炎的对照组： 1.年龄：2周岁至6周岁（含）。 2.无基础疾病，包括严重的慢性疾病：如心脏病、肾脏疾病、免疫系统疾病等；无急性感染疾病，包括感冒和流感、感染性腹泻、病毒感染等；受访者健康状态良好，精神状态佳，配合完成度高。

过敏性哮喘的疾病组： 1.	2周岁至6周岁（含）。 2.	意识清楚，精神健康，有言词表达能力、能自主行走者。 3.	反复出现喘息、咳嗽、气促、胸闷，常与接触变应原、冷空气、物理、化学性刺激、呼吸道感染、运动或过度通气等因素有关，且常在夜间和/或凌晨发作或加剧。 4.	发作时双肺可闻及散在或弥漫性哮鸣音，呼气相延长。 5.	排除其他疾病引起的喘息、咳嗽、气促和胸闷。 6.	对于临床表现不典型者，至少满足以下一项： 6.1支气管舒张试验阳性，即吸入速效β2受体激动剂后15分钟FEV1增加≥12%。 6.2抗炎治疗（吸入糖皮质激素和/或抗白三烯药物）4～8周后，FEV1增加≥12%。 6.3支气管激发试验阳性。 6.4最大呼气峰流量（PEF）日间变异率连续监测2周≥13%。 7.	具有典型的过敏病史或哮喘发作由暴露于过敏原触发。 8.	伴有过敏性鼻炎、食物过敏、湿疹或特应性皮炎等过敏性疾病。 9.       过敏原皮肤点刺试验阳性，或血清过敏原特异性IgE水平升高，或总IgE水平升高。 10.     外周血EOS计数增高；呼出气一氧化氮（FeNO）水平升高；诱导痰细胞学检查显示EOS比例增加。

过敏性哮喘的对照组： 1. 2周岁至6周岁（含） 2.无基础疾病，包括严重的慢性疾病：如心脏病、肾脏疾病、免疫系统疾病等；无急性感染疾病，包括感冒和流感、感染性腹泻、病毒感染等；受访者健康状态良好，精神状态佳，配合完成度高。

Inclusion criteria

Allergic Rhinitis disease group: 1. Age: 2 to 6 years old (inclusive). 2. Diagnostic basis: A clear diagnosis of allergic rhinitis. 3. Clinical symptoms: At least two of the following symptoms appear, and the symptoms last or accumulate for more than 1 hour every day: 3.1 Nasal congestion: intermittent or persistent, which can affect eating or sleeping. 3.2 Runny nose: a large amount of watery rhinorrhoea, which may be accompanied by an irritating cough. 3.3 Nasal itching: foreign body sensation or ant-like sensation, frequent nose rubbing. 3.4 Sneezing: paroxysmal attacks several times a day, more than 3 sneezes each time. 4. Signs: including pale nasal mucosa, edema, watery nasal secretions, etc. 5. Special signs: Allergic dark circles, Dennie Morgan lines, allergic wrinkles, and lip friction marks may appear. 6. Skin prick test: For children over 3 years old, the skin prick test of at least one allergen is positive; if there is no such test result, clinical symptoms will be the main factor. 7. Serum IgE test: The quantitative test of allergen sIgE is positive.

Control group of allergic rhinitis: 1. Age: 2 to 6 years old (inclusive). 2. No underlying diseases, including serious chronic diseases: such as heart disease, kidney disease, immune system disease, etc.; no acute infectious diseases, including colds and flu, infectious diarrhea, viral infections, etc.; the respondent is in good health and in good spirits, with a high degree of completeness.

Disease group of allergic asthma: 1. 2 years old to 6 years old (inclusive). 2. Those with clear consciousness, mental health, the ability to express themselves verbally, and the ability to walk independently. 3. Recurrent wheezing, coughing, shortness of breath, and chest tightness are often related to factors such as exposure to allergens, cold air, physical or chemical stimulation, respiratory infections, exercise or hyperventilation, and often occur at night and/or early in the morning or intensified. 4. During the attack, scattered or diffuse wheezing can be heard in both lungs, and the expiratory phase is prolonged. 5. Rule out wheezing, coughing, shortness of breath and chest tightness caused by other diseases. 6. For those with atypical clinical manifestations, at least one of the following must be met: 6.1 Positive bronchodilation test, that is, FEV1 increases by ≥12% 15 minutes after inhaling a fast-acting β2 receptor agonist. 6.2 After 4 to 8 weeks of anti-inflammatory treatment (inhaled glucocorticoids and/or anti-leukotriene drugs), FEV1 increases by ≥12%. 6.3 Bronchial provocation test is positive. 6.4 The maximum peak expiratory flow (PEF) daytime variability rate should be continuously monitored for 2 weeks to be ≥13%. 7. Have a history of classic allergies or asthma attacks triggered by exposure to allergens. 8. Accompanied by allergic diseases such as allergic rhinitis, food allergy, eczema or atopic dermatitis. 9. The allergen skin prick test is positive, or the serum allergen-specific IgE level is increased, or the total IgE level is increased. 10. The EOS count in peripheral blood increases; the exhaled nitric oxide (FeNO) level increases; induced sputum cytology shows an increase in the proportion of EOS.

Control group of allergic asthma: 1. 2 years old to 6 years old (inclusive) 2. No underlying diseases, including serious chronic diseases: such as heart disease, kidney disease, immune system disease, etc.; None Acute infectious diseases, including colds and flu, infectious diarrhea, viral infections, etc.; respondents are in good health, in good spirits, and have a high degree of cooperation.

排除标准：

过敏性鼻炎的疾病组 1. 无过敏性鼻炎的诊断或症状不符合过敏性鼻炎，其症状由其他已知病因引起。 2. 患有其他严重的慢性疾病：如心脏病、肾脏疾病、免疫系统疾病等；存在过敏性鼻炎引起的严重并发症：如严重哮喘、严重鼻窦炎、严重耳部感染等 3. 在进行皮肤点刺试验前未停用相关药物（如口服抗组胺药、含抗组胺药成分的抗感冒药、中成药、外用糖皮质激素）1周以上，或正在服用可能影响症状评估的其他药物。血清总IgE水平受年龄、寄生虫感染、其他炎症性疾病等因素影响，不能单独作为过敏性鼻炎的诊断依据。 4. 有严重的心理或行为问题，可能会干扰症状评估或治疗实施的儿童。无法遵守研究程序或随访安排的家庭。过敏性鼻炎的对照组： 1. 具有以下出现以下症状中的一项或以上，每日症状持续或累计超过1小时： 1.1鼻塞：间歇性或持续性，可影响进食或睡眠。 1.2 流涕：大量清水样涕，可能伴有刺激性咳嗽 1.3鼻痒：异物感或蚁行感，频繁揉鼻。 1.4喷嚏：每天数次阵发性发作，每次多于3个。 2. 受访者处于急性感染期，或患有慢性基础疾病；受访者服用特殊药物激素或抗生素等，具体结果根据负责医师给予诊断结果。 3.有严重的心理或行为问题，可能会干扰症状评估或治疗实施的儿童。无法遵守研究程序或随访安排的家庭。过敏性哮喘疾病组 1. 小于2周岁或者大于6周岁者。 3. 监护人员无阅读或言词表达能力者。 4. 存在其他可引起喘息的疾病，如喘息性支气管炎、气道异物、支气管肺发育不良等。 5. 合并肝肾功能不全、严重全身性疾病、免疫缺陷、先天性心脏病、癔症等。 6. 存在监护人沟通困难，无法配合研究者。过敏性哮喘的对照组：1. 年龄不符：不在2岁至6岁年龄的范围内。 2. 受访者处于急性感染期，或患有慢性基础疾病；受访者服用特殊药物激素或抗生素等，具体结果根据负责医师给予诊断结果。 3.有严重的心理或行为问题，可能会干扰症状评估或治疗实施的儿童。无法遵守研究程序或随访安排的家庭。

Exclusion criteria：

Allergic rhinitis disease group: 1. No diagnosis or symptoms of allergic rhinitis are not consistent with allergic rhinitis, and the symptoms are caused by other known causes. 2. Suffer from other serious chronic diseases: such as heart disease, kidney disease, immune system disease, etc.; have serious complications caused by allergic rhinitis: such as severe asthma, severe sinusitis, severe ear infection, etc. 3. During skin treatment You have not stopped taking relevant drugs (such as oral antihistamines, anti-cold drugs containing antihistamines, Chinese patent medicines, topical corticosteroids) for more than 1 week before the prick test, or you are taking other drugs that may affect symptom assessment . The total serum IgE level is affected by age, parasitic infection, other inflammatory diseases and other factors, and cannot be used alone as a basis for the diagnosis of allergic rhinitis. 4. Children with serious psychological or behavioral problems that may interfere with symptom assessment or treatment delivery. Families unable to comply with study procedures or follow-up schedules. Control group of allergic rhinitis: 1. Have one or more of the following symptoms, which last or accumulate for more than 1 hour every day: 1.1 Nasal congestion: intermittent or persistent, which can affect eating or drinking sleep. 1.2 Runny nose: a large amount of watery rhinorrhoea, which may be accompanied by an irritating cough. 1.3 Nasal itching: foreign body sensation or ant-like sensation, frequent nose rubbing. 1.4 Sneezing: paroxysmal attacks several times a day, more than 3 sneezes each time. 2. The respondent is in the acute infection stage, or suffers from chronic underlying diseases; the respondent takes special drugs, hormones or antibiotics, etc. The specific results are based on the diagnosis results given by the responsible physician. 3. Children with serious psychological or behavioral problems that may interfere with symptom assessment or treatment implementation. Families unable to comply with study procedures or follow-up schedules. Allergic asthma disease group: Exclusion criteria 1. Those younger than 2 years old or older than 6 years old. 3. The guardian has no ability to read or speak. 4. There are other diseases that can cause wheezing, such as asthmatic bronchitis, foreign bodies in the airways, bronchopulmonary dysplasia, etc. 5. Combined with liver and kidney insufficiency, severe systemic diseases, immune deficiency, congenital heart disease, hysteria, etc. 6. The guardian has difficulty communicating and cannot cooperate with the researcher. Control group of allergic asthma: 1. Age incompatibility: not within the age range of 2 to 6 years old. 2. The respondent is in the acute infection stage, or suffers from chronic underlying diseases; the respondent takes special drugs, hormones or antibiotics, etc. The specific results are based on the diagnosis results given by the responsible physician. 3. Children with serious psychological or behavioral problems that may interfere with symptom assessment or treatment implementation. Families unable to comply with study procedures or follow-up schedules.

研究实施时间：

Study execute time：

从 From 2024-01-01 00:00:00至 To 2026-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2024-10-01 00:00:00 至 To 2025-12-31 00:00:00

干预措施：

Interventions：

组别：	过敏性鼻炎组/ 过敏性鼻炎的对照组/ 过敏性哮喘组/ 过敏性哮喘的对照组	样本量：	90
Group：	Allergic Rhinitis Group/ Control group of allergic rhinitis/ Allergic Asthma Group/ Control group of allergic asthma	Sample size：	90
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)：	江苏	市(区县)：
Country：	China	Province：	Jiangsu	City：
单位(医院)：	无锡市儿童医院	单位级别：	三级甲等
Institution hospital：	Wuxi Children's Hospital	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	江苏	市(区县)：
Country：	China	Province：	Jiangsu	City：
单位(医院)：	南京市妇幼保健院	单位级别：	三甲
Institution hospital：	Nanjing Maternal and Child Health Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	蛋白质和基因表达量	指标类型：	主要指标
Outcome：	Protein and gene expression	Type：	Primary indicator
测量时间点：		测量方法：	提取队列成员的血浆和PBMC进行实验，然后根据血浆中蛋白质的含量进行测定，同时我们使用单细胞转录组进行PBMC的转录组测定，以此评估不同细胞之间的细胞基因表达改变。
Measure time point of outcome：		Measure method：	Extract plasma and PBMCs from cohort members for experimentation, then measure the protein content in the plasma. Simultaneously, we employ single-cell transcriptomics to perform transcriptomic profiling of PBMCs, in order to assess changes in gene expression between different cells.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	血	组织：
Sample Name：	Blood	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：	鼻拭子	组织：
Sample Name：	nasal swab	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	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：	腺样体	组织：
Sample Name：	adenoids	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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：

最小 Min age	2	岁 years
最大 Max age	6	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	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）：	NGDC数据库
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	NGDC database
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：	无
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	None
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2024-09-30 15:32:25