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临床试验/NCT04989374
NCT04989374Unknown不适用

Regulation of Vitamin D Metabolism by Washed Microbiota Transplantation in Patients With Inflammatory Bowel Disease

The Second Hospital of Nanjing Medical University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年3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
200
试验地点
1
主要终点
Changes of vitamin D levels in IBD patients after FMT treatment

研究概览

简要总结

WMT could effectively induce clinical response and maintain remission in patients with Inflammatory bowel disease (IBD). VD maintains gut microbiota and gut microbiota alter intestinal vitamin D metabolism (VDM),The aim of this study was to evaluate the effect of WMT on VD metabolism by measuring the level of serum 25(OH)D in IBD patients before and after treatment

详细描述

Inflammatory bowel disease (IBD) is a chronic, relapsing disorder that is represented by Crohn's disease (CD) and Ulcerative colitis (UC), the pathogenesis of IBD is not completely understood, but it is now acknowledged that it is related to intestinal microbiota. The gut microbiota is a central regulator of host metabolism, More and more evidences show that the gut microbiota plays an important physiological role in the pathogenesis of a variety of human metabolic, immune and neurological diseases, including IBD. Fecal microbiota transplantation (FMT) transplants the gut microbiota of healthy donors into the patients' intestines, This is an effective strategy to restore the intestinal microbiota and it is also a hot research topic in recent years. Our previous studies and other studies have proved that FMT could effectively induce clinical response and maintain remission in patients with IBD. Washed microbiota transplantation (WMT) is a fecal bacteria transplantation based on Intelligent fecal bacteria separation system and strict quality control of washing process, It is a new stage of FMT development, our group have proved that WMT is safer, more precise and more quality-controllable than the crude FMT by manual.

Vitamin D(VD) has been shown to have multifaced effects on the skeletal environment,immune system and infection. A number of diseases, including tumors, Type I diabetes, IBD and autoimmune diseases are associated with VD deficiency, VD could have an important role in the prevention and possible treatment of these conditions. Several studies have shown that intestinal microbiota is closely related to VD,VD maintains gut microbiota and gut microbiota alter intestinal vitamin D metabolism (VDM). A clinical trial shows that probiotics supplementation can change the level of 25 hydroxyvitaminD(25(OH)D). Serum 25(OH)D correlates with overall storage of VD, which is the preferred clinical measure to assess VD sufficiency. The aim of this study was to evaluate the effect of WMT on VD metabolism by measuring the level of serum 25(OH)D in IBD patients before and after treatment

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • IBD patients aged 16-65years

排除标准

  • previous history of partial small bowel resection;
  • Abnormal thyroid and parathyroid function;
  • Complicated with complicated intestinal fistula and severe infection and treated with antibiotics
  • Women during pregnancy, lactation and oral contraceptives.

结局指标

主要结局

Changes of vitamin D levels in IBD patients after FMT treatment

时间窗: 3 months

After WMT treatment, the level of vitamin d in IBD patients increased

次要结局

未报告次要终点

研究者

发起方
The Second Hospital of Nanjing Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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