NCT03228927Unknown不适用
Characterization of the Facial and Gut Microbiome in Identical and Fraternal Twins With Rosacea; Comparison to Healthy Controls
The Acne Cure Alliance0 个研究点目标入组 150 人开始时间: 2017年8月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 主要终点
- Characterization of the facial and fecal microbiome of monozygotic or dizygotic twins with facial rosacea
研究概览
简要总结
Questionnaires will be completed by each member of the twin set. A board-certified dermatologist will examine each member to categorize the type and severity of their rosacea. The facial and gut microbiome will be sampled and sent for microbial analysis.
详细描述
- Twin set subjects will be administered a questionnaire regarding demographics (age, gender, state of residence, time lived together, birth order), rosacea duration, prior rosacea treatment, diet (and similarity of diet to twin), co-morbidities, signs and symptoms suggestive of cardiovascular or gastrointestinal disease/disorder.
- Subjects will be examined by a board-certified dermatologist and global assessment, inflammatory counts and clinician's erythema score will be performed. Eyes will be examined for signs of ocular rosacea.
- Facial microbiome sampling will be performed on-site utilizing a kit manufactured by UBiome. The skin with active rosacea will be swabbed and the swab immediately placed in sample medium. The tube is then shipped to the manufacturer for 16s rRNA shotgun metagenomics to identify resident bacterial genera and species. (16) This can be compared to their extensive library of normal controls, to the other member of the twin set and to acne subjects.
- Subjects will be given a fecal microbiome kit for home sampling. Feces obtained from toilet paper is collected and placed in the sample medium. Subjects can either ship directly or return to the study site for shipping.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presenting with monozygotic or dizygotic twin
- •One or both twins with facial rosacea
- •Willingness to allow facial and fecal samples to be analyzed -
排除标准
- •Non-twin siblings
- •Absence of facial rosacea in both twins -
结局指标
主要结局
Characterization of the facial and fecal microbiome of monozygotic or dizygotic twins with facial rosacea
时间窗: Single sampling of facial microbiome done on site over a 2-day Festival August 5 and 6, 2017.
Characterization of the facial and fecal microbiome in monozygotic or dizygotic twins concordant or discordant for rosacea compared to a) each other, b) microbiome library of age-matched controls
次要结局
未报告次要终点
研究者
Hilary Baldwin
Medical Director
The Acne Cure Alliance
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