Exploring the link between gut bacteria and vitamin D in chronic hives
The Association Between Human Microbiome and Vitamin D in Chronic Urticaria
This study is testing if giving vitamin D to children with chronic hives can help improve their condition by looking at how it affects their gut bacteria.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 0 Years to 18 Years |
| Sex | All |
| Sponsor | China Medical University Hospital Academic / other |
| Locations | 1 site (Taichung) |
| Trial ID | NCT05497596 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between the human microbiome and vitamin D levels in children suffering from chronic urticaria, a persistent allergic condition. It involves a double-blind, randomized approach where children with chronic urticaria will receive either vitamin D or a placebo for six months. Blood and microbiome samples will be collected from participants to analyze the effects of vitamin D on their condition and the role of gut bacteria. The goal is to understand how these factors contribute to the development of urticaria.
Who should consider this trial
Good fit: Ideal candidates for this study are children under 18 years old diagnosed with chronic spontaneous urticaria.
Not a fit: Patients with recent use of antibiotics, systemic steroids, or those with severe underlying health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new treatment strategies for managing chronic urticaria in children.
How similar studies have performed: While the specific combination of microbiome and vitamin D in chronic urticaria is novel, related studies have shown promising results in understanding the role of microbiota in various allergic conditions.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Taichung
- China Medical University Hospital — Taichung, Taiwan (Recruiting)
Study contacts
- Study coordinator: Jiu-Yao Wang, MD
- Email: aim.cmuh@gmail.com
- Phone: 886422052121
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.