A comparative study to assess the fungal gut microbiome alterations in patients with chronic spontaneous urticaria and controls
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Fungal gut microbiome in patients with chronic spontaneous urticaria and healthy controls
研究概览
简要总结
This is a cross sectional study to assess the fungal gut gut microbiome alterations in chronic spontaneous urticaria compared to healthy controls. All clinically diagnosed cases of chronic spontaneous urticaria attending OPD and healthy controls satisfying the inclusion and exclusion criteria will be selected for the study. All participants will be subjected to detail history taking and a written informed consent will be obtained. Participants will provide stool samples which will be collected in sterile containers and stored at -80 degree celsius until processing. Total DNA will be extracted from the stool samples using a commercially available kit. The DNA samples will be then amplified, sequenced and analysed using ITS gene sequencing. This will allow us to determine fungal gut microbiome.
This study focuses on fungal gut microbiome alterations in patients with chronic spontaneous urticaria and thus providing a promising therapeutic option in future, thereby improving the quality of life in patients with chronic spontaneous urticaria.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinically diagnosed patients with chronic spontaneous urticaria CONTROLS-
- •Healthy individuals volunteering to participate in the study.
排除标准
- •Patients exposed to treatment with antifungals and proton pump inhibitors one month before sample collection
- •Patients with active fever or gastrointestinal infections
- •Patients with history of GI surgeries
- •Patients with immunodeficiency disorders, auto-inflammatory syndromes, urticarial vasculitis, severe infections
- •Patients treated with systemic corticosteroids, immunomodulators 1 month before sample collection CONTROLS-
- •Individuals with personal history of urticaria, atopic dermatitis, allergic rhinitis, conjunctivitis, asthma, anaphylaxis
- •Individuals with other dermatological diseases, GI infection or history of GI surgeries, those diagnosed with irritable bowel syndrome, inflammatory bowel disease and any other autoimmune diseases
- •Use of systemic antifungals, proton pump inhibitors, systemic steroids, immunomodulators one month before sample collection.
结局指标
主要结局
Fungal gut microbiome in patients with chronic spontaneous urticaria and healthy controls
时间窗: at baseline
次要结局
未报告次要终点
研究者
Haritha Prasanth
Amala Institute of Medical Sciences