ChiCTR2500103604 版本V1.0 版本创建时间2025/06/03 09:02:37 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2500103604 

最近更新日期：

Date of Last Refreshed on：

 2025-06-03 09:02:31 

注册时间：

Date of Registration：

 2025-06-03 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

口腔微生态与消化系统疾病发展规律及证候演变的相关性研究

Public title：

Study on the Correlation Between Oral Microbiota and the Developmental Law and Syndromes Evolution of Digestive System Diseases

注册题目简写：

English Acronym：

研究课题的正式科学名称：

口腔微生态与消化系统疾病发展规律及证候演变的相关性研究

Scientific title：

Study on the Correlation Between Oral Microbiota and the Developmental Law and Syndromes Evolution of Digestive System Diseases

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：

蓝洁莹 

研究负责人：

高磊 

Applicant：

Lan Jieying 

Study leader：

Gao Lei 

申请注册联系人电话：

Applicant telephone：

 +86 178 7571 3087

研究负责人电话：

Study leader's
telephone：

+86 156 2604 9576

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：

 lanjy2000@163.com

研究负责人电子邮件：

Study leader's E-mail：

 raygaolei@smu.edu.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：

广东省广州市海珠区江海街道石榴岗路13号

研究负责人通讯地址：

广东省广州市海珠区江海街道石榴岗路13号

Applicant address：

No. 13 Shiliugang Road, Jianghai Street, Haizhu District, Guangzhou, Guangdong

Study leader's address：

No. 13 Shiliugang Road, Jianghai Street, Haizhu District, Guangzhou, Guangdong

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：

南方医科大学中西医结合医院

Applicant's institution：

Southern Medical University Hospital of Integrated Traditional Chinese and Western Medicine

研究负责人所在单位：

南方医科大学中西医结合医院

Affiliation of the Leader：

Southern Medical University Hospital of Integrated Traditional Chinese and Western Medicine

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：

 2025006-202504-K1

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：

南方医科大学中西医结合医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee,Southern Medical University Hospital of Integrated Traditional Chinese and Western Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-04-23 00:00:00

伦理委员会联系人：

李爱荣

Contact Name of the ethic committee：

Li Airong

伦理委员会联系地址：

广东省广州市海珠区江海街道石榴岗路13号

Contact Address of the ethic committee：

No. 13 Shiliugang Road, Jianghai Street, Haizhu District, Guangzhou, Guangdong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 61650040

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 nfzxyec@163.com

研究实施负责（组长）单位：

南方医科大学中西医结合医院

Primary sponsor：

Southern Medical University Hospital of Integrated Traditional Chinese and Western Medicine

研究实施负责（组长）单位地址：

广东省广州市海珠区江海街道石榴岗路13号

Primary sponsor's address：

No. 13 Shiliugang Road, Jianghai Street, Haizhu District, Guangzhou, Guangdong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

广东

市(区县)：

Country：

China

Province：

Guangdong

City：

单位(医院)：

南方医科大学中西医结合医院

具体地址：

广东省广州市海珠区江海街道石榴岗路13号

Institution
hospital：

Southern Medical University Hospital of Integrated Traditional Chinese and Western Medicine

Address：

No. 13 Shiliugang Road, Jianghai Street, Haizhu District, Guangzhou, Guangdong

经费或物资来源：

自筹

Source(s) of funding：

Self raised

研究疾病：

消化系统疾病  

Target disease：

Diseases of the digestive system

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：

病例对照研究 

Study design：

Case-Control study 

研究目的：

1. 探讨口腔微生态与不同消化系统疾病的相关性。 2. 探究消化系统病变组织与正常组织中表达存在差异的关键基因和蛋白，阐明口腔微生态在消化系统疾病发生发展中的作用机制。 3. 探讨口腔微生态与肠道菌群的交互作用，揭示肠-口轴的微生态关系。 4. 解析口腔微生态与舌苔表型与证候演变规律的关系。 5. 评估中药干预对口腔微生态-消化系统疾病轴的调控效应。  

Objectives of Study：

1. To explore the correlation between oral microbiota and different digestive diseases. 2. Explore the key genes and proteins that are differently expressed in diseased and normal tissues of the digestive system, and elucidate the role of oral microbiota in the development of digestive system diseases. 3. Explore the interaction between oral microbiota and intestinal flora, and reveal the microecological relationship between intestinal-oral axis. 4.To analyze the relationship between oral microbiota and the tongue phenotype and syndromes. 5. To assess the regulatory effect of herbal intervention on the oral microbiota-digestive system disease axis.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

慢性胃炎 1）年龄为18~70岁；2）依据《中国慢性胃炎诊治指南（2022年，上海）》明确诊断为慢性胃炎，采用新悉尼系统取样法（胃窦和胃体各取2块，胃角取1块）取样后，根据慢性胃炎相关的悉尼系统病理评分标准、分级标准采用我国慢性胃炎的病理诊断标准(附录)和新悉尼系统的直观模拟评分法并用进行病理评估。 消化性溃疡 1）年龄为18~70岁；2）依据《消化性溃疡诊断与治疗共识意见（2022年，上海）》明确诊断消化性溃疡，胃镜下可见溃疡病灶，进行内镜下分期，并对溃疡边缘及周边组织多点取材，一般取4-6块，包括溃疡边缘和基底部，病理明确溃疡的深度、是否有活动性炎症、有无癌变倾向等。 胃肠道息肉 1）年龄为18~70岁；2）依据《胃肠道腺瘤和良性上皮性息肉的病理诊断共识》明确诊断胃肠道息肉，内镜下明确息肉大小和位置，病理明确息肉类型。 反流性食管炎 1）年龄为18~70岁；2）依据《中国胃食管反流病诊疗规范》明确诊断反流性食管炎，存在反酸、烧心等典型症状，胃镜下间食管粘膜破损，根据洛杉矶分级法进行分级。 溃疡性结肠炎 1）年龄为18~70岁；2）依据《中国溃疡性结肠炎诊治指南（2023年，西安）》明确诊断溃疡性结肠炎，肠镜下可见黏膜充血、水肿、糜烂、溃疡，附有脓性分泌物，后期可见炎性息肉，结肠袋变浅、变钝或消失，并根据溃疡性结肠炎相关的Mayo评分进行分期。 胃癌 入组标准：1）年龄为18~70岁；2）根据《中华医学会胃癌临床诊疗指南（2021版）》[35]明确诊断胃癌，胃镜下早期可见息肉样隆起或凹陷，或黏膜粗糙、色泽改变等，进展期可见明显的肿块、溃疡，溃疡边缘不规则，底部凹凸不平，可伴有出血、坏死等。对可疑病变部位多点活检，不少于5块，依据肿瘤细胞分化程度和TNM分期系统进行病理分级和分期。 结直肠癌 1）年龄为18~70岁；2）按照《中国结直肠癌诊疗规范》明确诊断结直肠癌，肠镜下可见隆起型、溃疡型、浸润型病变，明确病理分型，根据TNM分期系统进行分期。 正常人群 1）年龄18~70岁，自愿参与研究并签署知情同意书；2）近1年内因自主需求完成胃肠镜检查（非研究目的），结果未见器质性病变或活动性炎症；3）消化系统症状存在与否不限（可按需记录症状类型及频率）。

Inclusion criteria

Chronic gastritis (1) aged 18-70 years old; (2) clearly diagnosed with chronic gastritis according to the "China Chronic Gastritis Diagnostic and Treatment Guidelines (2022, Shanghai)", and after sampling using the new Sydney system sampling method (2 pieces of the antrum and the body of the stomach, and 1 piece of the gastric horns), the pathological diagnostic criteria for chronic gastritis (Appendix) and the new Sydney system were used for pathological evaluation according to the pathologic scoring standards of the Sydney system related to chronic gastritis and the grading criteria. Intuitive simulation scoring method and used for pathologic assessment. Peptic ulcer (1) Age 18-70 years old; (2) According to the "Consensus Opinion on the Diagnosis and Treatment of Peptic Ulcer (Shanghai, 2022)", the diagnosis of peptic ulcer was clearly made, the ulcer lesions were visible in gastroscopy, endoscopic staging was carried out, and multipoint sampling was performed for the margins of the ulcers and the peripheral tissues, generally 4-6 pieces of tissue were taken including the margins of the ulcers and the base of the ulcers, and pathology was clarified to determine the depth of the ulcers, whether there was active inflammation, whether there was any tendency to cancer, etc. The pathology was evaluated using the New Sydney System (Appendix). etc. Gastrointestinal polyps 1) Age 18-70 years old; 2) Gastrointestinal polyps should be clearly diagnosed according to the "Consensus on Pathologic Diagnosis of Gastrointestinal Adenomas and Benign Epithelial Polyps", and the size and location of the polyps should be clearly defined by endoscopy, and the type of polyps should be clearly defined by pathology. Reflux esophagitis 1) Age 18~70 years old; 2) Clear diagnosis of reflux esophagitis based on the Chinese GERD Diagnostic and Treatment Guidelines, presence of typical symptoms such as acid reflux and heartburn, and interstitial esophageal mucosal breakdown under gastroscopy, and grading based on the Los Angeles grading method. Ulcerative colitis 1) Age of 18 to 70 years old; 2) Clear diagnosis of ulcerative colitis according to the Chinese Guidelines for the Diagnosis and Treatment of Ulcerative Colitis (Xi'an, 2023), with mucosal congestion, edema, erosion, ulceration with purulent secretion visible under enteroscopy, inflammatory polyps visible in the later stages, and shallow, blunted, or disappearing of the colon pouch, and grading according to the Mayo score associated with ulcerative colitis. Gastric cancer Inclusion criteria: 1) age of 18-70 years old; 2) clear diagnosis of gastric cancer according to the Clinical Diagnosis and Treatment Guidelines for Gastric Cancer of the Chinese Medical Association (2021 edition) [35], polypoid bulges or depressions, or roughness of the mucosa, change of color, etc., could be seen in early stage by gastroscopy; in the progression stage, obvious masses and ulcers could be seen, and the edges of the ulcers were irregular, the bottom of the ulcers were uneven, which could be accompanied with hemorrhage and necrosis. Multipoint biopsy of suspicious lesions, not less than 5 pieces, pathological grading and staging based on the degree of differentiation of tumor cells and TNM staging system. Colorectal cancer (1) Age 18~70 years old; (2) Clear diagnosis of colorectal cancer according to the Chinese Colorectal Cancer Diagnostic and Treatment Guidelines, with bulging, ulcerative and infiltrative lesions visible under colonoscopy, clear pathological differentiation, and staging according to the TNM staging system. Normal population 1) aged 18~70 years old, voluntarily participate in the study and sign the informed consent; 2) complete gastroenteroscopy in the last 1 year due to independent needs (not for the purpose of the study), and the results do not show organic lesions or active inflammation; 3) the presence or absence of digestive symptoms is not limited (symptom type and frequency can be recorded on demand).

排除标准：

慢性胃炎 1）3个月内使用抗生素、益生菌；2）未处理的空洞龋病变、口腔脓肿、口腔黏膜出血等口腔疾病；3）严重的心脑肺疾病及肝肾功能障碍；4）存在胃部其他严重疾病；5）持续的传染病；6）患有严重的精神疾病。 消化性溃疡 1）3个月内使用抗生素、益生菌；2）未处理的空洞龋病变、口腔脓肿、口腔黏膜出血等口腔疾病；3）严重的心脑肺疾病及肝肾功能障碍；4）存在胃部其他严重疾病；5）上消化道出血、胃穿孔等严重并发症；6）持续的传染病；7）患有严重的精神疾病。 胃肠道息肉 1）3个月内使用抗生素、益生菌；2）未处理的空洞龋病变、口腔脓肿、口腔黏膜出血等口腔疾病；3）严重的心脑肺疾病及肝肾功能障碍；4）存在其他胃肠道严重疾病，如胃恶性肿瘤、结直肠癌等；5）持续的传染病；6）患有严重的精神疾病。 反流性食管炎 1）3个月内使用抗生素、益生菌；2）未处理的空洞龋病变、口腔脓肿、口腔黏膜出血等口腔疾病；3）严重的心脑肺疾病及肝肾功能障碍；4）存在其他胃肠道严重疾病，如食管癌、贲门失弛缓症等；5）持续的传染病；6）患有严重的精神疾病。 溃疡性结肠炎 1）3个月内使用抗生素、益生菌；2）未处理的空洞龋病变、口腔脓肿、口腔黏膜出血等口腔疾病；3）严重的心脑肺疾病及肝肾功能障碍；4）存在其他肠道严重疾病，如感染性肠炎等；5）中毒性巨结肠、肠穿孔、肠梗阻等并发症；6）持续的传染病；7）患有严重的精神疾病。 胃癌 1）3个月内使用抗生素、益生菌；2）未处理的空洞龋病变、口腔脓肿、口腔黏膜出血等口腔疾病；3）严重的心脑肺疾病及肝肾功能障碍；4）存在其他胃肠道严重疾病；5）恶性肿瘤转移；6）持续的传染病；7）患有严重的精神疾病。 结直肠癌 1）3个月内使用抗生素、益生菌；2）未处理的空洞龋病变、口腔脓肿、口腔黏膜出血等口腔疾病；3）严重的心脑肺疾病及肝肾功能障碍；4）存在其他胃肠道严重疾病；5）恶性肿瘤转移；6）持续的传染病；7）患有严重的精神疾病。 正常人群 1）胃肠镜检查提示异常（如溃疡、息肉、肿瘤、炎症性肠病等）；2）3个月内使用抗生素、益生菌；3）未处理的空洞龋病变、口腔脓肿、口腔黏膜出血等口腔疾病；4）严重的心脑肺疾病及肝肾功能障碍；5）恶性肿瘤转移；6）持续的传染病；7）患有严重的精神疾病。

Exclusion criteria：

Chronic gastritis 1) use of antibiotics and probiotics within 3 months; 2) untreated cavity caries lesions, oral abscesses, bleeding from the oral mucosa, and other oral diseases; 3) severe cardiac, cerebral, pulmonary, and hepatic and renal dysfunctions; 4) the presence of other serious diseases of the stomach; 5) persistent infectious diseases; and 6) suffering from severe psychiatric disorders. Peptic ulcer 1) use of antibiotics and probiotics within 3 months; 2) untreated cavity caries lesions, oral abscesses, bleeding from the oral mucosa, and other oral diseases; 3) severe cardio-cerebral and pulmonary diseases as well as hepatic and renal dysfunctions; 4) presence of other serious diseases of the stomach; 5) serious complications such as upper gastrointestinal bleeding and gastric perforation; 6) persistent infectious disease; and 7) suffering from serious mental illnesses. Gastrointestinal polyps 1) Use of antibiotics and probiotics within 3 months; 2) Oral diseases such as untreated cavity caries lesions, oral abscesses, bleeding from the oral mucosa, etc.; 3) Serious cardiac, cerebral and pulmonary diseases as well as hepatic and renal dysfunctions; 4) Presence of other serious diseases of the gastrointestinal tract such as gastric malignant tumors and colorectal cancers, etc.; 5) Ongoing infectious diseases; 6) Suffering from serious mental illness. Reflux esophagitis 1) use of antibiotics and probiotics within 3 months; 2) untreated cavity caries lesions, oral abscesses, bleeding from oral mucosa, and other oral diseases; 3) severe cardiac, cerebral, pulmonary, and hepatic and renal dysfunctions; 4) presence of other gastrointestinal tract serious diseases, such as esophageal carcinoma, pancreatic achalasia, and so on; 5) persistent infectious disease; and 6) suffering from serious mental illnesses. Ulcerative colitis 1) use of antibiotics and probiotics within 3 months; 2) oral diseases such as untreated cavity caries lesions, oral abscesses, and bleeding from the oral mucosa; 3) severe cardiac, cerebral, and pulmonary diseases, and hepatic and renal dysfunctions; 4) the presence of other serious diseases of the gastrointestinal tract, such as infectious enterocolitis; 5) complications such as toxic megacolon, intestinal perforation, and intestinal obstruction; 6) persistent infectious disease; and 7) suffering from serious mental illnesses. Gastric cancer 1) use of antibiotics and probiotics within 3 months; 2) untreated cavity caries lesions, oral abscesses, bleeding from oral mucosa, and other oral diseases; 3) severe cardiac, cerebral, pulmonary, and hepatic and renal dysfunctions; 4) the presence of other gastrointestinal serious diseases; 5) metastasis of malignant tumors; 6) persistent infectious diseases; and 7) suffering from serious mental illnesses. Colorectal cancer 1) use of antibiotics and probiotics within 3 months; 2) untreated oral diseases such as cavity caries lesions, oral abscesses, bleeding from the oral mucosa, etc.; 3) severe cardio-cerebral and pulmonary diseases as well as hepatic and renal dysfunctions; 4) the presence of other gastrointestinal serious diseases; 5) metastasis of malignant tumors; 6) persistent infectious diseases; and 7) suffering from serious mental illnesses. Normal population 1) Gastroenteroscopy suggesting abnormalities (e.g. ulcers, polyps, tumors, inflammatory bowel disease, etc.); 2) use of antibiotics and probiotics within 3 months; 3) untreated cavity caries lesions, oral abscesses, bleeding from the oral mucosa, and other oral diseases; 4) severe cardio-cerebral and pulmonary diseases and hepatic and renal dysfunctions; 5) metastasis of malignant tumors; 6) persistent infectious diseases; and 7) suffering from serious mental illnesses.

研究实施时间：

Study execute time：

从 From 2025-05-01 00:00:00至 To 2030-04-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-06-06 00:00:00 至 To 2030-04-01 00:00:00

干预措施：

Interventions：

组别：

疾病组

样本量：

 808

Group：

Disease group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

组别：

对照组

样本量：

 169

Group：

Control subjects

Sample size：

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)：

 广东 

市(区县)：

  

Country：

China

Province：

Guangdong

City：

单位(医院)：

 南方医科大学中西医结合医院 

单位级别：

 三甲 

Institution
hospital：

Southern Medical University Hospital of Integrated Traditional Chinese and Western Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

口腔微生态

指标类型：

主要指标

Outcome：

Oral microbiota

Type：

Primary indicator

测量时间点：

测量方法：

16SrRNA、宏基因组等

Measure time point of outcome：

Measure method：

16SrRNA, macrogenomes, etc.

指标中文名：

胃肠道症状

指标类型：

次要指标

Outcome：

Gastrointestinal symptoms

Type：

Secondary indicator

测量时间点：

测量方法：

问卷、医生评估

Measure time point of outcome：

Measure method：

Questionnaire, physician assessment

指标中文名：

表达存在差异的关键基因和蛋白

指标类型：

次要指标

Outcome：

Key genes and proteins with differential expression

Type：

Secondary indicator

测量时间点：

测量方法：

基因组学、蛋白组学等组学技术，免疫组化、蛋白印迹试验等实验室技术

Measure time point of outcome：

Measure method：

Genomics, proteomics and other histological techniques,Laboratory techniques such as immunohistochemistry and Western Blot

指标中文名：

疾病分期（级）

指标类型：

主要指标

Outcome：

Disease stage (grade)

Type：

Primary indicator

测量时间点：

测量方法：

胃肠镜、病理

Measure time point of outcome：

Measure method：

Gastroenterology, Pathology

指标中文名：

肠道菌群

指标类型：

次要指标

Outcome：

Intestinal flora

Type：

Secondary indicator

测量时间点：

测量方法：

16SrRNA、宏基因组等

Measure time point of outcome：

Measure method：

16SrRNA, macrogenomes, etc.

指标中文名：

舌苔

指标类型：

次要指标

Outcome：

Tongue

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

中医体质与辩证

指标类型：

主要指标

Outcome：

Physique and dialectics in Chinese medicine

Type：

Primary indicator

测量时间点：

测量方法：

问卷、医生评估

Measure time point of outcome：

Measure method：

Questionnaire, physician assessment

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

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

标本中文名：

胃肠道组织

组织：

胃肠道

Sample Name：

Gastrointestinal tract tissue

Tissue：

Gastrointestinal tract

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：

Faeces

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：

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 18 岁 years
最大 Max age 70 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:

公开/Public

盲法：

Blinding：

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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(2030-10-01,ResMan)

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

None(2030-10-01,ResMan)

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：

电子采集

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

EDC

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-06-03 09:02:31