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临床试验/NCT05311293
NCT05311293Unknown不适用

Study on the Molecular Mechanism of Diarrhea-predominant Irritable Bowel Syndrome With Anxiety and Depression Based on Multi-omics Correlation Analysis

Tang-Du Hospital1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2021年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
15
试验地点
1
主要终点
Anxiety and Depression Score

研究概览

简要总结

The research group intends to carry out a case-control study to recruit IBS-D patients with anxiety and depression symptoms, by collecting intestinal mucosa for single-cell transcriptome sequencing, collecting peripheral blood for proteomic analysis, the two groups and patient symptoms are associated, and then discover the characteristics of molecular level changes associated with brain-gut axis dysfunction, explore the pathophysiological mechanism of comorbid anxiety and depression and IBS, and discover potential targets for effective treatment. This project can help to construct the colonic single-cell map of IBS-D patients and explore the differentially expressed genes in the colon of IBS patients and their signaling pathways related to neuroregulation, providing an effective therapeutic target for the treatment of comorbid anxiety and depression and IBS.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Meet the Rome IV diagnostic criteria for diarrhea-predominant irritable bowel syndrome;
  • Aged between 18 and 65 years old (inclusive), male or female;
  • HAMA assessment ≥ 14 points or HAMD assessment ≥ 17 points

排除标准

  • Patients with severe cardiovascular and cerebrovascular diseases (such as myocardial infarction, cerebral infarction, coronary heart disease, etc.);
  • Abnormal liver and kidney function (ALT or AST > 1.5 times the upper limit of normal, or T-Bil > 1.5 times the upper limit of normal, or Cr more than the upper limit of normal), hematopoietic system diseases and tumors;
  • Patients with a history of abdominal surgery (except appendectomy and cholecystectomy);
  • Previous diagnosis of organic diseases of the digestive system, such as inflammatory bowel disease, intestinal tuberculosis, etc., or still associated with peptic ulcer, infectious diarrhea, etc.;
  • Previous diagnosis of diseases similar to irritable bowel syndrome symptoms, such as eosinophilic enteritis, microscopic colitis (including collagen colitis and lymphocytic colitis), lactose intolerance, malabsorption syndrome;
  • Previous diagnosis of non-intestinal digestive system diseases, such as tuberculous peritonitis, gallstones, cirrhosis, chronic pancreatitis;
  • Previous diagnosis of diseases affecting the digestive tract function, such as hyperthyroidism or hypothyroidism, endometriosis, autoimmune diseases, diabetes, etc.;
  • Patients who have taken drugs with bleeding risk or increased bleeding risk before treatment;
  • Patients who have taken antidepressant drugs and psychotropic drugs before treatment;
  • Use drugs that affect gastrointestinal motility and function, such as prokinetic drugs, anticholinergic drugs, calcium channel blockers, 5-HT receptor agonists/antagonists, antidiarrheal agents, antacids, intestinal bacteria modulators and antibiotics;
  • Allergic constitution;
  • Pregnant and lactating women; Others that may affect study compliance or adversely affect the results as judged by the investigator.

结局指标

主要结局

Anxiety and Depression Score

时间窗: up to 100 weeks

To evaluate the extent to which a disease affects a mental condition

次要结局

未报告次要终点

研究者

发起方
Tang-Du Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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