NCT05728060已完成不适用
Associations of Fecal Bile Acid Profile and Intestinal Flora With Chronic Radiation Enteritis
Xijing Hospital of Digestive Diseases1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Correlation between fecal bile acid profile and chronic radiation enteritis
研究概览
简要总结
To explore the fecal bile acid profile of patients with radiation enteritis, to clarify the types of bile acids that are closely related to the occurrence of radiation enteritis; to explore the interaction between fecal bile acids and intestinal flora in patients with radiation enteritis, and to lay the foundation for further elucidation of the pathogenesis of radiation enteritis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •. non-surgical cervical cancer patients aged 18 to 75 years who received radiotherapy;
- •. Patients who can fully understand the content of informed consent for this trial and voluntarily sign the written informed consent;
- •. able to receive follow-up examinations, follow-up examinations, and specimen retention on time;
- •. The case group met the diagnostic criteria for chronic radiation enteritis in the "Expert Consensus on the Diagnosis and Treatment of Radiation Proctitis in China (2018 edition)"; Control group 1: Non-surgical cervical cancer patients without chronic radiation enteritis after radiotherapy; Control group 2: Patients with cervical cancer who did not receive any treatment.
- •Exclusion Criteria;
- •. Presence of diseases affecting bile acid metabolism, such as hepatitis and cirrhosis of the liver from various causes, gallstones, etc;
- •. Patients who have previously undergone cholecystectomy or partial resection of the intestine;
- •. Taking drugs affecting bile acid metabolism due to other diseases, such as cholestyramine, anti-inflammatory and Xiaoyan lidan tablets, Danshu capsules, ursodeoxycholic acid, obeticholic acid, and proprietary Chinese medicines such as schisandrin B, Tanshinone IIA, and Yinjiazhuang;
- •. Recent use of drugs that affect gastrointestinal motility;
- •. Patients with moderate or severe renal impairment (blood creatinine > 2 mg/dL or 177 mmol/L), or abnormal liver function (ALT > 2 times the upper limit of normal value); moderate or severe chronic obstructive pulmonary disease; patients with severe hypertension, patients with cerebrovascular accidents; patients with congestive heart failure, unstable angina pectoris;
- •. Patients with mental or legal disabilities;
- •. Suspected or confirmed history of alcohol/substance abuse or other pathology that, in the judgment of the investigator, reduces the likelihood of enrollment or complicates enrollment;
- •. Refuse to sign informed consent;
排除标准
- 未提供
结局指标
主要结局
Correlation between fecal bile acid profile and chronic radiation enteritis
时间窗: 7 months
Patients' fecal bile acid profiles were analyzed by ultra-performance liquid chromatography-tandem mass spectrometry and screened for the bile acids associated with chronic radiation enteritis.
次要结局
- Correlation between fecal bile acid profile and intestinal microbiota in different groups.(7 months)
研究者
Yongquan Shi
Principal Investigator, Clinical Professor
Xijing Hospital of Digestive Diseases
研究点 (1)
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