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：	ChiCTR2400089743
最近更新日期： Date of Last Refreshed on：	2024-09-14 08:45:03
注册时间： Date of Registration：	2024-09-14 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	自身免疫性胃炎的临床特征及胃内菌群变化分析
Public title：	Analysis of clinical features and changes of intragastric flora in autoimmune gastritis
注册题目简写：
English Acronym：
研究课题的正式科学名称：	自身免疫性胃炎的临床特征及胃内菌群变化分析
Scientific title：	Analysis of clinical features and changes of intragastric flora in autoimmune gastritis
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：	李昊峰	研究负责人：	兰春慧
Applicant：	Li Haofeng	Study leader：	Lan Chunhui
申请注册联系人电话： Applicant telephone：	+86 183 2301 1796	研究负责人电话： Study leader's telephone：	+86 138 9606 7955
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：	1091962356@qq.com	研究负责人电子邮件： Study leader's E-mail：	1091962356@qq.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：	重庆市渝中区长江支路10号	研究负责人通讯地址：	重庆市渝中区长江支路10号
Applicant address：	No.10, Changjiang Branch Road, Yuzhong District, Chongqing, China	Study leader's address：	No.10, Changjiang Branch Road, Yuzhong District, Chongqing, 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：	陆军特色医学中心
Applicant's institution：	Army Medical Center of PLA
研究负责人所在单位：	陆军特色医学中心
Affiliation of the Leader：	Army Medical Center of PLA

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：	医研伦审(2024)第270号	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：	中国人民解放军陆军特色医学中心伦理委员会
Name of the ethic committee：	Ethics Committee of The Army Medical Center of PLA
伦理委员会批准日期： Date of approved by ethic committee：	2024-09-03 00:00:00
伦理委员会联系人：	陈东风
Contact Name of the ethic committee：	Chen Dongfeng
伦理委员会联系地址：	重庆市渝中区大坪长江支路10号
Contact Address of the ethic committee：	No.10, Changjiang Branch Road, Yuzhong District, Chongqing, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 23 6875 7140	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：

陆军特色医学中心

Primary sponsor：

Army Medical Center of PLA

研究实施负责（组长）单位地址：

重庆市渝中区长江支路10号陆军特色医学中心

Primary sponsor's address：

No.10, Changjiang Branch Road, Yuzhong District, Chongqing, 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)：	重庆	市(区县)：	渝中
Country：	China	Province：	Chongqing	City：	Yuzhou
单位(医院)：	陆军特色医学中心	具体地址：	长江支路10号
Institution hospital：	Army Medical Center of PLA	Address：	No.10, Changjiang Branch Road, Yuzhong District, Chongqing, China

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Self selected topic (self funded)

研究疾病：

自身免疫性胃炎

Target disease：

Autoimmune Gastritis

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：

回顾性研究

Study phase：

Retrospective study

研究设计：

非随机对照试验

Study design：

Non randomized control

研究目的：

第一部分：通过收集AIG患者的临床资料，总结AIG患者的临床特征。第二部分：了解AIG患者胃内菌群分布的情况，探索菌群的差异是否引起了AIG并发症、预后之间的差异。

Objectives of Study：

Part 1: Summarize the clinical characteristics of AIG patients by collecting their clinical data. Part 2: Understand the distribution of gastric microbiota in AIG patients and explore whether differences in microbiota cause differences in AIG complications and prognosis.

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

Part 1: Patients diagnosed with AIG at the Army Characteristic Medical Center between January 2020 and June 2024, with an estimated sample size of around 100 cases. (Diagnostic criteria: ① Obvious retrograde atrophy phenomenon is found under endoscopy (the degree of atrophy of the gastric antrum is weaker than that of the gastric body and fundus); ② The results of histology (pathological biopsy reveals atrophy of the gastric body or fundus, accompanied by neuroendocrine cell proliferation and loss of parietal cells) or serology (positive for anti parietal cell antibodies or anti intrinsic factor antibodies) are either positive.
Part 2: 1. Age: Adults, 18-80 years old, male or female not limited; 2. Observation group: Diagnosed with AIG (diagnostic criteria: ① Significant retrograde atrophy observed under endoscopy (the degree of atrophy of the gastric antrum is weaker than that of the gastric body and fundus); ② The results of histology (pathological biopsy reveals atrophy of the gastric body or fundus, accompanied by neuroendocrine cell proliferation and loss of parietal cells) or serology (positive for anti parietal cell antibodies or anti intrinsic factor antibodies) are either positive; 3. Control group: Diagnosed with chronic non atrophic gastritis under endoscopy, with negative 13C urea breath test.

排除标准：

1. 试验组排除标准：（1）存在其它影响本研究评价的严重疾病如严重的肝、肾、心血管病等疾病；（2）无法进行内镜检查者；（3）凝血功能障碍、长期服用抗凝、抗血小板药物或其他原因导致无法进行胃粘膜活检术者；（4）妊娠期或哺乳期妇女；（5）不能签署知情同意书者；（6）一个月内有PPI、P-CAB、铋剂、抗生素、微生物制剂使用史；（7）胃大部切除术、消化性溃疡活动期、反流性食管炎、食管溃疡等病史；2.对照组排除标准：（1）存在其它影响本研究评价的严重疾病如严重的肝、肾、心血管病等疾病；（2）合并其他消化道疾病如消化性溃疡、息肉、炎症性肠病、恶性肿瘤等；（3）无法进行内镜检查者；（4）凝血功能障碍、长期服用抗凝、抗血小板药物或其他原因导致无法进行胃粘膜活检术者；（5）妊娠期或哺乳期妇女；（6）不能签署知情同意书者；（7）一个月内有PPI、P-CAB、铋剂、抗生素、微生物制剂使用史；（8）有HP根除史；（9）尿素呼气试验阳性

Exclusion criteria：

1. Exclusion criteria for the experimental group: (1) the presence of other serious diseases that affect the evaluation of this study, such as severe liver, kidney, cardiovascular disease, etc; (2) Individuals who are unable to undergo endoscopic examination; (3) Patients with coagulation dysfunction, long-term use of anticoagulant or antiplatelet drugs, or other reasons that prevent gastric mucosal biopsy surgery; (4) Pregnant or lactating women; (5) Those who cannot sign the informed consent form; (6) History of using PPI, P-CAB, bismuth agents, antibiotics, and microbial preparations within one month; (7) History of subtotal gastrectomy, active peptic ulcer, reflux esophagitis, esophageal ulcer, etc; 2. Exclusion criteria for the control group: (1) the presence of other serious diseases that affect the evaluation of this study, such as severe liver, kidney, cardiovascular disease, etc; (2) Merge other gastrointestinal diseases such as peptic ulcers, polyps, inflammatory bowel disease, malignant tumors, etc; (3) Individuals who are unable to undergo endoscopic examination; (4) Patients with coagulation dysfunction, long-term use of anticoagulant or antiplatelet drugs, or other reasons that prevent gastric mucosal biopsy surgery; (5) Pregnant or lactating women; (6) Those who cannot sign the informed consent form; (7) History of using PPI, P-CAB, bismuth agents, antibiotics, and microbial preparations within one month; (8) History of HP eradication; (9) Positive urea breath test

研究实施时间：

Study execute time：

从 From 2024-10-10 00:00:00至 To 2026-06-30 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2024-10-10 00:00:00 至 To 2026-06-30 00:00:00

干预措施：

Interventions：

组别：	前瞻性研究-自身免疫性胃炎的胃内菌群变化分析——试验组	样本量：	60
Group：	Prospective Study - Analysis of Changes in Gastric Microbiota in Autoimmune Gastritis - Experimental Group	Sample size：	60
干预措施：	患有自身免疫性胃炎	干预措施代码：
Intervention：	Suffering from autoimmune gastritis	Intervention code：

组别：	前瞻性研究-自身免疫性胃炎的胃内菌群变化分析——对照组	样本量：	30
Group：	Prospective Study - Analysis of Changes in Gastric Microbiota in Autoimmune Gastritis - Control Group	Sample size：	30
干预措施：	无。对照组为内镜下诊断为慢性非萎缩性胃炎，13C-尿素呼气试验为阴性。同时不患有其他胃肠道疾病或影响研究的重大疾病。	干预措施代码：
Intervention：	None. Controls were endoscopically diagnosed with chronic non-atrophic gastritis and negative 13C-urea breath test. Also not suffering from other gastrointestinal disorders or major diseases affecting the study.	Intervention code：

组别：	回顾性研究-自身免疫性胃炎的临床特征研究	样本量：	100
Group：	A retrospective study - Clinical characterization of autoimmune gastritis	Sample size：	100
干预措施：	患有自身免疫性胃炎	干预措施代码：
Intervention：	Suffering from autoimmune gastritis	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	重庆	市(区县)：
Country：	China	Province：	Chongqing	City：
单位(医院)：	陆军特色医学中心	单位级别：	三甲
Institution hospital：	Army Medical Center of PLA	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	胃粘膜菌群分布情况	指标类型：	主要指标
Outcome：	Distribution of gastric mucosal flora	Type：	Primary indicator
测量时间点：	取得胃黏膜后冻存3个月内	测量方法：	16S rRNA测序
Measure time point of outcome：	Within 3 months of obtaining gastric mucosa and freezing it	Measure method：	16S rRNA sequencing

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	胃粘膜	组织：
Sample Name：	Gastric mucosa	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	80	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）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

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）：	研究结果发表之后的6个月内，公开于 ResMan 网站（http://www.medresman.org.cn/）
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	The results of the study were made available on the ResMan website (http://www.medresman.org.cn/) within 6 months of 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：	研究者对每位受试者在试验中的所有相关资料均应及时、真实地记录在案，并做好确认和签名。CRF不得随意更改，确实需要更改时研究者应签名并注明日期（见填写说明）。试验结束后CRF由研究者所在医院的临床试验机构和申办者保存。完成的CRF由临床监查员审查后，进行数据录入，内容不再修改。为保证受试者的隐私权，在CRF上的受试者姓名需使用代码。研究者应当使资料保存完整。对于临床的所有原始资料研究者应保存到临床试验终止后5年。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	The investigator should record all the relevant information of each subject in the trial in a timely and truthful manner, and make a good confirmation and signature.The CRF shall not be changed arbitrarily, and the investigator should sign and date it when it is really necessary to change it (see the instructions for filling in the CRF). After the trial is completed, the CRF is kept by the clinical trial organization of the hospital where the investigator works and by the sponsor. The completed CRF is reviewed by the clinical supervisor for data entry and the content is not modified. To ensure the privacy of the subjects, a code is required for the subject's name on the CRF. The investigator should keep the data intact. For clinical purposes, all original data should be kept by the investigator until 5 years after the termination of the clinical trial.
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2024-09-14 08:44:59