NCT06153654招募中不适用
Role of the Nasal Microbiota in Obesity - the microNASA Study
Katharina Timper1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年7月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Difference in nasal microbiota composition
研究概览
简要总结
The primary aim of this study is to investigate the nasal environment in obese and lean individuals.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •N=50 adult male and female patients with obesity will be included in this study.
- •Inclusion criteria:
- •Inclusion criteria:
- •Age 18-55 years
- •Written informed consent
- •BMI > 30 kg/m2
- •N=50 adult lean patients age- and sex-matched to the group of obese patients will be included in this study.
- •Inclusion criteria:
- •Age 18-55 years
- •Written informed consent
- •BMI 18-25 kg/m2
- •N=50 adult male and female patients with obesity with scheduled bariatric will be included in this study
- •Inclusion criteria:
- •Age 18-55 years
- •Written informed consent
- •BMI > 35 kg/m2
排除标准
- •Chronic or acute sinusitis
- •Surgical intervention of the nasal cavity or the paranasal sinus
- •Use of antibiotics within the last 31 days18
- •Current illicit drug abuse including daily marijuana or CBD consumption (≤ 24 g of alcohol per day allowed)
- •Any kind of severe chronic disease (e.g. severe heart failure, active cancer disease)
- •Use of any kind of decongestant more than twice a week
- •Use of cortisone-containing nasal spray within the last 3 months
- •Acute allergic rhinitis
- •History of neurodegenerative diseases
- •History of severe head trauma
- •Severe renal impairment (e.g. estimated glomerular filtration rate <30 ml/min/m2)
结局指标
主要结局
Difference in nasal microbiota composition
时间窗: 6 Months
The microbiome of the nasal cavity will be analyzed by isolating DNA from Nasal Swabs through amplicon sequencing. We will define the primary endpoint as the difference in nasal microbiome in obese vs. sex- and age-matched lean control individuals.
次要结局
- Change in nasal microbiota Composition after bariatric surgery(24 Months)
研究者
Katharina Timper
Prof. Dr. med.
University Hospital, Basel, Switzerland
研究点 (1)
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