ChiCTR2500109998 版本V1.0 版本创建时间2025/09/28 16:24:39 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：

 ChiCTR2500109998 

最近更新日期：

Date of Last Refreshed on：

 2025-09-28 16:24:34 

注册时间：

Date of Registration：

 2025-09-28 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

个性化精准匹配肠道菌群移植创新技术中心的建设

Public title：

Evaluating the Efficacy of Precision-Matched Microbiota Transplantation in Treating Intestinal Diseases.

注册题目简写：

English Acronym：

研究课题的正式科学名称：

个性化精准匹配肠道菌群移植创新技术中心的建设

Scientific title：

Evaluating the Efficacy of Precision-Matched Microbiota Transplantation in Treating Intestinal 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：

黄华丽 

研究负责人：

黄华丽 

Applicant：

Huali Huang 

Study leader：

Huali Huang 

申请注册联系人电话：

Applicant telephone：

 +86 155 7812 0846

研究负责人电话：

Study leader's
telephone：

+86 182 7719 1725

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：

 3304529608@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 3304529608@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：

广西南宁市青秀区七星路89号

研究负责人通讯地址：

广西南宁市青秀区七星路89号

Applicant address：

No. 89, Qixing Road, Qingxi District, Nanning City, Guangxi Province

Study leader's address：

No. 89, Qixing Road, Qingxi District, Nanning City, Guangxi Province

申请注册联系人邮政编码：

Applicant postcode：

 530022

研究负责人邮政编码：

Study leader's postcode：

 530022

申请人所在单位：

南宁市第一人民医院

Applicant's institution：

The First People's Hospital of Nanning

研究负责人所在单位：

南宁市第一人民医院

Affiliation of the Leader：

The First People's Hospital of Nanning

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：

 KY2025-意见-139

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：

南宁市第一人民医院医学伦理委员会

Name of the ethic committee：

The Medical Ethics Committee of the First People's Hospital of Nanning

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-08-20 00:00:00

伦理委员会联系人：

凌宇

Contact Name of the ethic committee：

Yu Ling

伦理委员会联系地址：

广西南宁市青秀区七星路89号

Contact Address of the ethic committee：

No. 89, Qixing Road, Qingxi District, Nanning City, Guangxi Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 771 263 6250

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：

南宁市第一人民医院

Primary sponsor：

The First People's Hospital of Nanning,Nanning Science and Technology Bureau

研究实施负责（组长）单位地址：

广西南宁市青秀区七星路89号

Primary sponsor's address：

No. 89, Qixing Road, Qingxi District, Nanning City, Guangxi Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

广西壮族自治区

市(区县)：

南宁市

Country：

china

Province：

Guangxi province

City：

Nanning

单位(医院)：

南宁市第一人民医院

具体地址：

广西南宁市青秀区七星路89号

Institution
hospital：

The First People's Hospital of Nanning

Address：

No. 89, Qixing Road, Qingxi District, Nanning City, Guangxi Province

经费或物资来源：

南宁市第一人民医院，南宁市科学技术局

Source(s) of funding：

The First People's Hospital of Nanning ,Nanning Bureau of Science and Technology

研究疾病：

炎性肠病、慢性胃炎、便秘  

Target disease：

Inflammatory Bowel Disease(IBD),Chronic Gastritis,Chronic Constipation

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 I期临床试验 

Study phase：

1

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

本研究旨在通过系统的肠道菌群移植（FMT）干预试验，深入探索微生物组重建对特定疾病的治疗潜力及其作用机制。基于前期研究发现肠道菌群失调与多种慢性疾病密切相关的科学证据。我院自从2019年建设FMT亚专科，至今已完成约2000例次移植，积累了丰富的经验及大量的病例，移植的主要病种有重症急性胰腺炎、急性肝衰竭、脂肪肝、慢性乙型病毒性肝炎、慢性腹泻、慢性便秘、肠易激综征、自闭症、2型糖尿病、老年痴呆、焦虑抑郁状态等疾病。目前移植的菌种均为健康供体所提供的粪便，分为菌液移植及胶囊移植。基于此亚专科技术平台及多病种病例的积累，我们拟开展多病种的FMT的供体-受体匹配研究，通过对既往FMT病例的供体-受体肠道菌群BC距离与C2R的相关性，以及该二者参数对移植反应、预后的影响检验BC距离对不同病种接受FMT的C2R及疗效的影响；并通过开展前瞻性随机对照研究，以C2R为评估指标，检验BC距离在FMT治疗不同疾病中的临床应用价值，有助于建立基于C2R为预后预测指标指导BC距离应用FMT匹配模型，进一步提高BC距离匹配模型的精准性。最终将基于BC距离匹配模型、C2R评估指标及FMT技术集成，形成一个适应不同病种不同个体的个性化精准匹配FMT创新技术，在该技术上建立一个理论扎实、技术先进、硬件过硬、人才队伍合理的技术中心。  

Objectives of Study：

This study aims to conduct a systematic Fecal Microbiota Transplantation (FMT) intervention trial to thoroughly investigate the therapeutic potential and mechanistic underpinnings of microbiome reconstruction for specific diseases. This initiative is grounded in prior scientific evidence linking gut dysbiosis to various chronic conditions.Since establishing the FMT sub-specialty in 2019, our hospital has performed approximately 2,000 transplant procedures, accumulating extensive experience and a substantial patient cohort. The primary diseases treated include severe acute pancreatitis, acute liver failure, fatty liver disease, chronic hepatitis B, chronic diarrhea, chronic constipation, irritable bowel syndrome, autism spectrum disorder, type 2 diabetes, Alzheimer's disease, and states of anxiety and depression. The transplanted microbiota is derived exclusively from healthy donors, administered either as bacterial suspensions or capsules.Leveraging this specialized technical platform and diverse patient database, we propose to investigate donor-recipient matching across multiple diseases. We will analyze retrospective FMT data to examine the correlation between the Bray-Curtis (BC) distance of donor-recipient gut microbiota and the C2R index, and further assess how these parameters influence transplant response and prognosis. Subsequently, we will conduct prospective randomized controlled trials using C2R as a key evaluation metric to validate the clinical utility of the BC distance in FMT for various diseases.The ultimate goal is to develop a personalized, precision FMT technology. This innovation will integrate the BC distance matching model, the C2R prognostic predictor, and advanced FMT delivery techniques, forming a cohesive system adaptable to different diseases and individuals. The establishment of a theoretical sound, technologically advanced, and well-equipped technical center with a skilled team will be foundational to this endeavor.

药物成份或治疗方案详述：

胶囊的制作：用无菌容器采集粪便，样品重量不少于100g，Bristol评分标准3-5分判?定为合格，立即进入菌液制作流程，或立即密封后?2-8°C保存;从粪便排?出体外至菌液制作完成应保证在2小时以内，整个处理过程应在无菌环境?下操作。为了避免感染窗口期的问题，胶囊制备后应待21天后经过病毒细?菌等检验合格后出库，每批产品留样至少6个月以供追溯。 治疗方案：匹配BC距离最高的供体来源后，进行胶囊移植。  

Description for medicine or protocol of treatment in detail：

Capsule Preparation and Treatment Protocol 1. Capsule Preparation Fecal samples are collected using sterile containers. A sample weighing no less than 100 grams, with a Bristol Stool Scale score of 3 to 5, is deemed qualified. The sample must immediately proceed to the bacterial suspension preparation process or be securely sealed and stored at 2-8℃. The entire processing interval, from defecation to the completion of the bacterial suspension, must be confined within 2 hours, with all manipulations conducted under aseptic conditions. To mitigate the risk of infections during the window period, the prepared capsules are quarantined for 21 days. They are released for use only after passing subsequent viral and bacterial testing. A batch sample from each production lot is retained for at least 6 months for traceability purposes. 2. Treatment Protocol Upon matching with a donor source demonstrating the highest Bray-Curtis (BC) similarity distance, capsule transplantation is administered. 

纳入标准：

供体组纳入标准： 1.年龄>18 岁，BMI: 18.5-25 kg/m^2，自愿参加本项目研究。 2.家族疾病史:无任何遗传性疾病史、肿瘤家族史、精神疾病史。 3.自身疾病史:无胃肠道状况或症状(如 IBD病史、肠易激综合征、慢性腹泻、慢性便秘、腹腔疾病、肠切除术或减肥手术等),也包括过去两周内的急性腹泻或胃肠道状况;无重要胃肠道疾病的家族史(如IBD或结 直肠癌家族史);无共济失调史;无任何系统性自身免疫性疾病、代谢疾 病、神经或精神疾病，无已知的肮病毒疾病风险;无慢性疼痛综合征、恶 性肿瘤的病史。 4.用药史:无服用特定常规药物，或在过去3个月内服用此类药物， 如抗生素、质子泵抑制剂、免疫抑制、化疗药物及其他生物制品药物等。 5.疫苗接种史:过去6个月内无接种减毒活病毒过去6个月内无接受试验药物或疫苗的病史。 6.冶游史:6个月内未到过热带国家旅行。6个月内未到过任何传染 病聚集地。 7.高危行为:过去6个月内无血液传播病毒的危险因素，包括高危性行为、使用非法药物、任何刺青、纹身、针刺受伤、输血或针灸。 受体组纳入标准： 1.符合各亚组疾病的诊断标准; 2.自愿接受FMT治疗; 3.年龄>18 岁; 4.BMI: 18.5-25 kg/m^2; 5.肝肾、心肺疾病或精神正常; 6.无胃肠道手术史; 7.无致命疾病、无肿瘤病史。

Inclusion criteria

Donor Inclusion Criteria 1. Age & Consent: > 18 years, Body Mass Index (BMI) 18.5-25 kg/m2, voluntary participation. 2. Family History:Absence of genetic disorders, family history of malignancies, or psychiatric illnesses. 3. Personal Medical History:No gastrointestinal conditions (e.g., IBD, IBS, chronic diarrhea/constipation, celiac disease, bowel resection, bariatric surgery) or acute gastrointestinal symptoms within the past two weeks. No significant family history of gastrointestinal diseases (e.g., IBD, colorectal cancer). No history of ataxia, systemic autoimmune diseases, metabolic diseases, neurological/psychiatric disorders, prion disease risk, chronic pain syndromes, or malignancies. 4. Medication History: No use of specific medications within the past 3 months (e.g., antibiotics, proton pump inhibitors, immunosuppressants, chemotherapeutic agents, biologics). 5. Vaccination & Experimental Drug History:No administration of live-attenuated vaccines or receipt of any experimental drugs/vaccines within the past 6 months. 6. Travel History:No travel to tropical countries or areas with known clusters of infectious diseases within the past 6 months. 7. High-Risk Behaviors:No risk factors for blood-borne viruses within the past 6 months (e.g., high-risk sexual behavior, illicit drug use, tattoos, piercings, needle-stick injuries, blood transfusions, acupuncture). Recipient Inclusion Criteria 1. Meets the diagnostic criteria for the specific disease subgroup. 2. Voluntary acceptance of Fecal Microbiota Transplantation (FMT) treatment. 3. Age > 18 years. 4. Body Mass Index (BMI) 18.5-25 kg/m2. 5. Normal hepatic, renal, cardiopulmonary function; no psychiatric disorders. 6. No history of gastrointestinal surgery. 7. No life-threatening illnesses or history of malignancies.

排除标准：

供体组排除标准：在项目进行的任何一个阶段提出退出实验者，尚未进行FMT的粪便样 品按医疗垃圾处理，但已被移植的样品不进行退回，如已完成FMT的移植 及随访等生成完整数据，则相关数据继续纳入分析。 受体组排除标准： 1.在项目进行的任何一个阶段主动或被动退出实验者，如已完成FMT的移植及随访等生成完整数据，其相关数据继续纳入分析。 2.重的先天性解剖异常; 3.继发性便秘:继发于药物、内分泌、代谢、神经或精神等因素; 4.怀孕或哺乳的女性; 5.肠道病原体感染的征象; 6.过去3个月内服用抗生素或 PPIS; 7.过去1个月内服用过益生菌、益生元或合生元; 8.过去1个月内吸烟或酗酒; 9.合并影响肠动力的疾病或服用影响肠动力的药物，如抗抑郁药、阿片类麻醉性镇痛药、抗胆碱能药、钙拮抗剂、硝酸盐、抗毒碱药等。

Exclusion criteria：

Donor Group Exclusion Criteria: Donors will be excluded from the study if they choose to withdraw at any stage of the project. Fecal samples that have not yet been used for Fecal Microbiota Transplantation (FMT) will be disposed of as medical waste. Samples that have already been transplanted cannot be retrieved. However, if the FMT procedure and subsequent follow-up for a donor have been completed, generating a complete dataset, the relevant data will continue to be included in the analysis. Recipient Group Exclusion Criteria: Recipients will be excluded from the study based on the following criteria: 1. Voluntary or involuntary withdrawal from the study at any stage. Similar to donors, if a recipient has completed the FMT procedure and follow-up, generating a complete dataset, their data will be retained for analysis. 2. Severe congenital anatomical abnormalities. 3. Secondary constipation attributable to factors such as medications, endocrine, metabolic, neurological, or psychiatric disorders. 4. Pregnancy or lactation in female participants. 5. Evidence of active intestinal pathogenic infection. 6. Use of antibiotics or proton pump inhibitors (PPIs) within the past 3 months. 7. Consumption of probiotics, prebiotics, or synbiotics within the past month. 8. Smoking or excessive alcohol consumption within the past month. 9. Co-existing conditions affecting intestinal motility, or use of medications known to influence motility (e.g., antidepressants, opioid analgesics, anticholinergics, calcium channel blockers, nitrates, antispasmodics).

研究实施时间：

Study execute time：

从 From 2025-10-10 00:00:00至 To 2027-04-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-10-10 00:00:00 至 To 2027-04-30 00:00:00

干预措施：

Interventions：

组别：

对照组（传统FMT法）

样本量：

 90

Group：

Control Group (Conventional FMT)

Sample size：

干预措施：

采用常规供体选择方案，即选择合格的亲缘供体或随机选择供体来源粪便胶囊进行FMT

干预措施代码：

Intervention：

For the control group, FMT was performed using the conventional donor selection protocol, which involved choosing either a qualified related donor or a randomly

Intervention code：

组别：

实验组（经C2R模型匹配后的FMT）

样本量：

 90

Group：

Experimental Group (FMT following C2R model matching)

Sample size：

干预措施：

在供体肠道菌群数据库内匹配尚有胶囊库存且BC距离最高的供体来源粪 便胶囊进行FMT

干预措施代码：

Intervention：

FMT was performed using fecal capsules from the donor with the highest Bray-Curtis distance who had available capsule inventory in the donor gut microbiota database.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广西 

市(区县)：

 南宁 

Country：

China

Province：

Guangxi

City：

Nanning

单位(医院)：

 南宁市第一人民医院 

单位级别：

 三甲 

Institution
hospital：

The First People's Hospital of Nanning

Level of the institution：

None

测量指标：

Outcomes：

指标中文名：

BC距离(肠道菌群差异)

指标类型：

主要指标

Outcome：

Bray-Curtis distance

Type：

Primary indicator

测量时间点：

FMT治疗后3个月

测量方法：

使用vegan in R与属丰富度计算，使用r中的ade4包对所有样本的成对BC距离矩阵进行柱坐标分析（PCoA)）

Measure time point of outcome：

3 months after FMT treatment

Measure method：

Use vegan in R to calculate alpha diversity, and perform principal coordinates analysis (PCoA) on the pairwise BC distance matrix of all samples using the ade4 package in R.

指标中文名：

C2R

指标类型：

主要指标

Outcome：

Colonizers to Residents

Type：

Primary indicator

测量时间点：

FMT治疗后3个月

测量方法：

C2R是通过在对数空间中殖民者(移植菌)和居民（原有菌）之间的总和丰度的比率来计算的

Measure time point of outcome：

3 months after FMT treatment

Measure method：

The C2R was calculated by the ratio of summed abundance between colonizers and residents in log-space

指标中文名：

肠道菌群组成

指标类型：

次要指标

Outcome：

Gut microbiota composition

Type：

Secondary indicator

测量时间点：

FMT治疗后3个月

测量方法：

提取粪便进行16srRNA检测

Measure time point of outcome：

3 months after FMT treatment

Measure method：

Extract faeces for 16s rRNA testing.

指标中文名：

原发病缓解情况

指标类型：

主要指标

Outcome：

Primary disease remission status

Type：

Primary indicator

测量时间点：

FMT治疗后3个月

测量方法：

患者症状好转、胃肠镜显示病变较前好转

Measure time point of outcome：

3 months after FMT treatment

Measure method：

The patient's symptoms have improved, and the gastroenteroscopy shows that the lesions have improved compared to before.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

粪便

组织：

肠道

Sample Name：

fecal

Tissue：

intestinal tract

人体标本去向

 使用后销毁  

说明

使用后销毁

Fate of sample：

Destruction after use  

Note：

Destroy after use.

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 65 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）：

由一名技术员按照随机数表法分配干预组与对照组

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

A technician will assign the intervention group to the control group according to the random number table method

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：

双盲

Blinding：

Double blind

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：

本研究将采用专门设计的纸质病例记录表 进行数据采集。CRF将严格依据研究方案设计，包含所有需要收集的数据点。CRF中的数据均来源于患者的原始医疗记录（源文件）。由经过培训的研究人员将数据准确转录至CRF。

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

The CRFs will be strictly developed based on the study protocol to encompass all required data points. All data entered into the CRFs will be sourced from patients' original medical records (source documents). Trained research personnel will be responsible for accurately transcribing the data from these source documents into the CRFs.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2025-09-28 16:24:34