Clinical trial NCT05497596: The Association Between Human Microbiome and Vitamin D in Chronic Urticaria
Official title: The Association Between Human Microbiome and Vitamin D in Chronic Urticaria
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urticaria
Keywords: Vitamin D
human microbiome
vitamin D receptors and vitamin D binding protein
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2022-08-11
Enrollment: 150
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Levels of vitamin D
timeFrame: Month 0
measure: Levels of vitamin D
timeFrame: Month 6
measure: Single nucleotide polymorphism of vitamin D receptor and vitamin D binding protein.
timeFrame: Month 0
measure: Microbiome Microbiome
timeFrame: Month 0
measure: Microbiome Microbiome
timeFrame: Month 6
measure: Total IgE
timeFrame: Month 0
measure: Total IgE
timeFrame: Month 6
measure: Allergen-specific IgE
timeFrame: Month 0
Secondary outcomes:
measure: Quality of Life Assessment
timeFrame: Month 0 to Month 6
measure: The Urticaria Activity Score 7 (UAS7)
timeFrame: Month 0 to Month 6
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
References: