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The Clinical Efficacy of Gegen Qinlian Tang Combined with Bifidobacterium Triple Viable Capsules in the Prevention and Treatment of Radiation Enteritis

注册号：

Registration number：

ITMCTR2025000085

最近更新日期：

Date of Last Refreshed on：

2025-01-13

注册时间：

Date of Registration：

2025-01-13

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

葛根芩连汤联合双歧杆菌三联活菌胶囊防治放射性肠炎临床疗效观察

Public title：

The Clinical Efficacy of Gegen Qinlian Tang Combined with Bifidobacterium Triple Viable Capsules in the Prevention and Treatment of Radiation Enteritis

注册题目简写：

English Acronym：

研究课题的正式科学名称：

葛根芩连汤联合双歧杆菌三联活菌胶囊防治放射性肠炎临床疗效观察

Scientific title：

The Clinical Efficacy of Gegen Qinlian Tang Combined with Bifidobacterium Triple Viable Capsules in the Prevention and Treatment of Radiation Enteritis

研究课题的正式科学名称简写：

Scientific title acronym：

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：

王璐

研究负责人：

曾灵芝

Applicant：

Lu Wang

Study leader：

Lingzhi Zeng

申请注册联系人电话：

Applicant telephone：

13970260604

研究负责人电话：

Study leader's telephone：

13879233399

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：

xuezhxi1988@163.com

研究负责人电子邮件：

Study leader's E-mail：

dawn3399@sina.com

申请单位网址(自愿提供)：

Study leader's 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：

江西省九江市八里湖新区九江市第一人民医院总院8号楼4楼

研究负责人通讯地址：

江西省九江市八里湖新区九江市第一人民医院总院8号楼4楼

Applicant address：

4th Floor Building 8 General Hospital of Jiujiang City First People's Hospital Balihu New District Jiujiang City Jiangxi Province.

Study leader's address：

4th Floor Building 8 General Hospital of Jiujiang City First People's Hospital Balihu New District Jiujiang City Jiangxi Province.

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：

九江市第一人民医院

Applicant's institution：

Jiujiang First People's Hospital

是否获伦理委员会批准：

Approved by ethic committee：

伦理委员会批件文号：

Approved No. of ethic committee：

JJSDYRMYY-YXLL-2024-193

伦理委员会批件附件：

Approved file of Ethical Committee：

View

批准本研究的伦理委员会名称：

九江市第一人民医院医学伦理委员会

Name of the ethic committee：

Jiujiang First People's Hospital Medical Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2024/9/2 0:00:00

伦理委员会联系人：

聂梦君

Contact Name of the ethic committee：

MengJun Nie

伦理委员会联系地址：

江西省九江市八里湖新区九江市第一人民医院1号楼5楼

Contact Address of the ethic committee：

5th Floor Building 1 Jiujiang First People's Hospital Balihu New District Jiujiang City Jiangxi Province.

伦理委员会联系人电话：

Contact phone of the ethic committee：

13979267976

伦理委员会联系人邮箱：

Contact email of the ethic committee：

2857509839@qq.com

研究实施负责（组长）单位：

九江市第一人民医院

Primary sponsor：

Jiujiang First People's Hospital

研究实施负责（组长）单位地址：

江西省九江市八里湖新区九江市第一人民医院总院

Primary sponsor's address：

Hospital of Jiujiang City First People's Hospital Balihu New District Jiujiang City Jiangxi 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)：

江西

市(区县)：

九江

Country：

China

Province：

Jiangxi

City：

Jiujiang

单位(医院)：

九江市第一人民医院

具体地址：

江西省九江市八里湖新区九江市第一人民医院总院

Institution
hospital：

Jiujiang First People's Hospital

Address：

Hospital of Jiujiang City First People's Hospital Balihu New District Jiujiang City Jiangxi Province.

经费或物资来源：

江西省中医药管理局

Source(s) of funding：

Jiangxi Provincial Administration of Traditional Chinese Medicine

研究疾病：

腹部及盆腔恶性肿瘤

研究疾病代码：

Target disease：

Abdominal and pelvic malignant tumors

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段：

Study phase：

其它

Others

研究目的：

放射性肠炎（Radiation Enteritis， RE）是指腹腔、盆腔或腹膜后的恶性肿瘤由于放射治疗引起的肠道并发症，严重影响患者的生活质量，临床上除在放疗中进行物理剂量学上限制，尚无有效手段来防治RE，故探究更多有效防治RE的方法和手段迫在眉睫。研究表明人体肠道内相互依存的微生态系肠道内菌群在放射治疗后将产生了显著变化，放射性肠炎中患者粪球菌出现明显富集，而未发生放射肠炎的患者肠道菌群基线的多样性更高，故通过调节肠道菌群可防治放射肠炎。临床上常用的双歧杆菌可以通过诱导胃肠道的各类免疫细胞产生细胞因子，减少辐射引起结肠上皮屏障的破坏，起到调控炎症与修复作用，对放射性肠炎有预作用。葛根芩连汤通过调节肠道菌群，促进乳酸菌、阿克曼菌属等有益细菌的生长，并抑制对粪球菌、拟杆菌等潜在致病菌的生长，从而减轻炎肠道炎症。本研究采用葛根芩连汤联合双歧杆菌对腹部放疗的患者进行干预，预计可有效改善肠道微生物群落结构，减少RE的发生,提高患者生存质量。

Objectives of Study：

Radiation Enteritis (RE) refers to the intestinal complications caused by radiotherapy in malignant tumors of the abdominal cavity pelvis or retroperitoneum which severely affect the quality of life of patients. In clinical practice apart from limiting the physical dose in radiotherapy there are currently no effective means to prevent and treat RE. Therefore it is urgent to explore more effective methods and means to prevent and treat RE. Studies have shown that the microecological system of the human intestine which is composed of interdependent gut flora undergoes significant changes after radiotherapy. Patients with RE show a marked enrichment of fecal bacteria while those without RE have a higher baseline diversity of intestinal flora. Thus regulating the gut flora can prevent and treat RE. The commonly used Bifidobacteria in clinical practice can induce various immune cells in the gastrointestinal tract to produce cytokines reduce the destruction of the colonic epithelial barrier caused by radiation and play a role in regulating inflammation and repair which is preventive for RE. Gegen Qinlian Tang by regulating the gut flora promotes the growth of beneficial bacteria such as lactobacilli and Akkermansia and inhibits the growth of potential pathogens such as fecal bacteria and Bacteroides thereby reducing intestinal inflammation. This study uses Gegen Qinlian Tang in combination with Bifidobacteria for intervention in patients undergoing abdominal radiotherapy and it is expected to effectively improve the structure of the intestinal microbial community reduce the occurrence of RE and improve the quality of life of patients.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

（1）年龄＞18岁，＜80岁；(2)均细胞学检查或病理检查确诊为恶性肿瘤,且根据指南依据行腹部或者盆腔放疗的患者;(3)意识清晰、思维正常,具备良好的交流沟通能力;（4）均获取家属及患者意愿,自愿配合实验, 并签署协议书;

Inclusion criteria

(1) Age greater than 18 years and less than 80 years; (2) All patients have been diagnosed with malignant tumors through cytological or pathological examinations and are candidates for abdominal or pelvic radiotherapy according to the guidelines; (3) Conscious and thinking clearly with good communication skills; (4) Family members and patients have been informed and are willing to cooperate with the experiment and have signed an informed consent form.

排除标准：

（1）既往明确严重肠道疾病患者，包括缺血性肠病、溃疡性结肠炎、克罗恩病等；（2）近2年内有接受抗生素治疗史者；（3）合并严重肝肾功能不全的患者。(4)患有其他重大疾病,无法配合实验,或中途退出者;(5)不愿暴露病历资料,或资料缺损者。

Exclusion criteria：

(1) Patients with a history of severe intestinal diseases including ischemic bowel disease ulcerative colitis Crohn's disease etc.; (2) Those who have received antibiotic treatment within the past 2 years; (3) Patients with severe liver and kidney dysfunction. (4) Those with other major illnesses who cannot cooperate with the experiment or who withdraw midway; (5) Individuals unwilling to disclose medical records or with incomplete information.

研究实施时间：

Study execute time：

从From 2025-01-01

至To      2027-06-30

征募观察对象时间：

Recruiting time：

从From 2025-01-01

至To      2026-06-30

干预措施：

Interventions：

组别：

对照组

样本量：

20

Group：

Control group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

组别：

干预组

样本量：

20

Group：

Intervention Group

Sample size：

干预措施：

双歧杆菌三联胶囊

干预措施代码：

Intervention：

On the basis of the Bifidobacterium triple viable capsule group oral administration of Gegen Qinlian Tang with additions and subtractions is used

Intervention code：

组别：

联合药物干预组

样本量：

20

Group：

Combination drug intervention group

Sample size：

干预措施：

双歧杆菌三联胶囊组基础上口服葛根芩连汤加减

干预措施代码：

Intervention：

On the basis of the Bifidobacterium triple viable capsule group oral administration of Gegen Qinlian Tang with additions and subtractions is used

Intervention code：

样本总量 Total sample size ： 60

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

江西省

市(区县)：

九江市

Country：

China

Province：

JiangXi

City：

Jiujiang

单位(医院)：

九江市第一人民医院

单位级别：

三级甲等医院

Institution/hospital：

Jiujiang First People's Hospital

Level of the institution：

Class III Grade A Hospital

测量指标：

Outcomes：

指标中文名：

急性放射性损伤分级标准/欧洲癌症治疗研究组织（RTOG/EORTC）分级

指标类型：

主要指标

Outcome：

Acute Radiation Injury Grading Criteria / RTOG/EORTC Grading

Type：

Primary 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：

大便常规

组织：

Sample Name：

Routine fecal analysis

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：

尚未开始

Not yet recruiting

年龄范围：

最小 18 岁
Min age years
最大 80 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

男女均可

Both

随机方法（请说明由何人用什么方法产生随机序列）：

随机序列是由独立的统计学家使用专业的随机化软件（例如SAS或R软件）生成的。该统计学家在整个研究过程中保持独立，不参与其他任何与研究相关的工作，以确保随机序列的公正性和不可预测性。随机化过程在患者签署知情同意书并满足所有入组标准后进行。我们没有采用任何形式的区组随机化或分层随机化，因为本研究为单臂设计，主要目的是评估药物的疗效和安全性，而非比较不同治疗组之间的差异。

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

The random sequence is generated by an independent statistician using professional randomization software (such as SAS or R software). This statistician remains independent throughout the entire research process and does not participate in any other research-related work to ensure the fairness and unpredictability of the random sequence. The randomization process is conducted after the patient has signed the informed consent form and met all the inclusion criteria. We did not use any form of block randomization or stratified randomization because this study is a single-arm design and the main purpose is to evaluate the efficacy and safety of the drug rather than comparing differences between different treatment groups.

盲法：

Blinding：

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）：

预计2028年通过发表在NCBI网络平台方式

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

The raw data is expected to be shared through publication on the NCBI platform in 2028

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：

采用病例记录和数据采集方式进行记录

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

Data collection and recording are carried out using Case Record Forms and electronic data capture methods

数据管理委员会：

Data Managemen Committee：

有

Yes

研究计划书或研究结果报告发表信息
（杂志名称、期、卷、页，时间；或网址）：

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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