跳至主要内容
临床试验/NCT05652621
NCT05652621招募中不适用

Clinical Efficacy and Mechanism of Probiotics in the Adjuvant Treatment of Ulcerative Colitis and Irritable Bowel Syndrome

The First Affiliated Hospital of Xinxiang Medical College1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年7月31日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Changes of intestinal flora

研究概览

简要总结

This research group plans to take patients with mild to moderate UC and diarrhea IBS diagnosed in the First Affiliated Hospital of Xinxiang Medical College as examples, and divide them into UC group and IBS group; Each group was randomly divided into two groups, namely, conventional treatment+probiotics group and conventional treatment+probiotics placebo group.Starting from the intervention of probiotics on intestinal flora to alleviate intestinal injury caused by UC and IBS patients, the indicators of intestinal flora, serum inflammatory factors, metabolites in vivo, intestinal barrier-related protein expression, and fecal short-chain fatty acid level were detected to explore the clinical efficacy, intestinal protective effect and mechanism of probiotics in adjuvant treatment of UC and IBS patients.To provide new methods and new ideas for refractory UC and IBS, so as to improve the cure rate of UC and IBS, reduce the recurrence rate, relieve the physical and mental pain and economic burden of patients, and provide new ideas for the development and utilization of functional probiotics. It also seeks biosafety evidence for the future use of probiotics in antibiotic environment.

详细描述

Some studies suggest that IBS is related to UC, and it is speculated that IBS may be a mild UC. Some researchers have also reported that more and more UC patients have irritable bowel syndrome-like symptoms unrelated to intestinal inflammatory activities in remission.At present, it is generally believed that the imbalance of intestinal flora is the main cause of UC and IBS. At present, antibiotics are still the main drugs to treat this disease.Antibiotic treatment often destroys the intestinal microecology, which makes the intestinal microecology unbalanced. Therefore, it is of great guiding significance to find a safe and effective way of dietary intervention.Therefore, our research group induced mice with Dextran Sulfate Sodium Salt (DSS), and successfully established a mouse ulcerative colitis model. On this basis, we used HE staining (histological score), IHC, qPCR and other methods to explore the compound functional mixed strains of probiotics (probiotics for short, The ingredients include: resistant dextrin (water-soluble dietary fiber), Lactobacillus reuteri PLBK1, Lactobacillus reuteri PLBK2, Lactobacillus Grignard PLBK3, Lactobacillus acidophilus PLBK4, Bifidobacterium lactis PLBK5) and their metabolites (feces) to assist the molecular mechanism of ulcerative colitis. The experimental results show that probiotics can significantly improve the symptoms of ulcerative colitis induced by DSS and promote the remission of enteritis.Therefore, in view of the research foundation that our animal experiments have achieved remarkable results, our research group carried out a clinical trial of human medicine in the First Affiliated Hospital of Xinxiang Medical College, and further explored the intervention of probiotics in intestinal flora to assist in the treatment of inflammation. Clinical effect and mechanism of sexual bowel disease. To provide new methods and new ideas for improving the cure rate of UC and IBS, reducing the recurrence rate, alleviating the physical and mental pain and economic burden of patients; At the same time, it provides new ideas for the development and utilization of functional probiotics. It also seeks biosafety evidence for the future use of probiotics in antibiotic environment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of ulcerative colitis
  • Clinical diagnosis of irritable bowel
  • Can swallow probiotic pellets as required

排除标准

  • indeterminate colitis,suspected IBD

结局指标

主要结局

Changes of intestinal flora

时间窗: 4-12 weeks

collecting the feces of patients before and after taking medicine, and carrying out genomics analysis.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验