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临床试验/NCT05497596
NCT05497596招募中不适用

The Association Between Human Microbiome and Vitamin D in Chronic Urticaria

China Medical University Hospital2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年8月2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
150
试验地点
2
主要终点
Microbiome Microbiome

研究概览

简要总结

A double-blind study to evaluate the role of human microbiome and vitamin D in the development of urticaria.

详细描述

Urticaria is a chronic allergic inflammatory disorder. Genetic and environmental factors, such as exposure to allergens and microbes, have a detrimental role in the development of chronic urticaria. Vitamin D also has an important role in urticaria. Lower sera vitamin D level was observed in patients that developed urticaria. Vitamin D binding protein (DBP) bound to vitamin D and regulated its metabolites in the circulation. Moreover, vitamin D receptors (VDR) have been identified on nearly all cells of the immune system. It may contribute to maintenance of intestinal barrier function by preventing increased intestinal permeability, dysbiosis, inflammation, and a lack of immune tolerance in the gut.

The investigators plan to design a double-blind trial to evaluate the role of human microbiome and vitamin D in the development of urticaria. We will enroll children with chronic urticaria (CU) and age and gender matched healthy children,and collected their venous blood and microbiome samples of nasal and anal swab. Then, CU subjects will be given vitamin D or placebo for 6 months in a randomized, double-blind way. After six months of follow-up, their blood, nasal cavity, and intestinal bacterial samples were taken. All microbial analysis, allergen detection, vitamin D concentration, VDR, DBP genotype will be analyzed by the core laboratory and bioinformatics center of CMUH.

The investigators believe this study can answer the cause-effect relationships of microbiota and vitamin D in the development of CU, and design a microbiota-related preventive and treatment strategy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • Experimental group: patients with chronic spontaneous urticaria under the age of 18 .
  • Control group: healthy children under the age of 18 (eg, healthy siblings of sick children).

排除标准

  • Recruit patients who have used antibiotics, systemic steroids, and immunosuppressants in the previous month.
  • Patients with C1 esterase inhibitor deficiency, lymphocytopenia, thrombocytopenia, severe diseases involving heart, liver, or kidney, metabolic disease, or autoimmune disease.

结局指标

主要结局

Microbiome Microbiome

时间窗: Month 6

Nasal and anal swabs will be used to detect respiratory and intestinal microbiome by using 16S rRNA sequencing,and to follow the change from baseline in microbiome at month 6.

Single nucleotide polymorphism of vitamin D receptor and vitamin D binding protein.

时间窗: Month 0

Single nucleotide polymorphism (SNP) genotyping will be performed in a blood sample by using TaqMan SNP genotyping assays.

Allergen-specific IgE

时间窗: Month 0

Plasma allergen-specific IgE will be measured by BioIC ®.

Levels of vitamin D

时间窗: Month 6

Vitamin D will be measured in a blood sample to follow the change from baseline in vitamin D level at month 6.

Total IgE

时间窗: Month 6

Plasma total IgE concentration will be measured by microparticle immunoassay (IMx analyzer, Abbott Laboratories, Abbott Park, IL) and ELISA to follow the change from baseline in total IgE at month 6.

次要结局

  • Quality of Life Assessment(Month 0 to Month 6)
  • The Urticaria Activity Score 7 (UAS7)(Month 0 to Month 6)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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