Lipidome and Microbiome Profile of Acne
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in the diversity of the gut microbiome before and after the treatment of doxycycline in those with acne.
研究概览
简要总结
Lipidome and microbiome analysis in subjects with acne on doxycycline. Investigators will look at the skin lipidome, blood lipidome, gut micro biome and skin micro biome.
Investigators will look at the changes between acne subjects and control participants, but also the changes that occur after the use of antibiotics and how this is altered.
详细描述
We will look at acne subjects, and controls.
We will look at four things
- skin lipidome
- skin microbiome
- gut microbiome
- blood lipidome
Investigators will assess this in acne participants before and after doxycycline and compare them to controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 15 and older
- •Subjects/parents/legal guardian is able to read and comprehend study procedure and consent forms.
- •Have already been prescribed Doxycycline by their physician for acne or to be eligible to be prescribed Doxycycline for acne
- •Have acne that is diagnosed by a board certified dermatologist.
排除标准
- •Those who have received systemic antibiotics within four weeks of starting the study.
- •Those who have received systemic isotretinoin within six weeks of starting the study.
- •Those with seborrheic dermatitis, rosacea, or polycystic ovary syndrome
- •Those who are pregnant, prisoners or cognitively impaired.
- •Those subjects who are currently using proton pump inhibits (as studies have shown this may impact the gut microbiome) (4)
- •Those who have a BMI greater than >30 kg/m2, as studies have shown a reduction in the variability of intestinal microbes within this population (5).
- •Those who have initiated or changed brand of oral contraceptive pill within 4 weeks of starting the study.
- •Those who have autoimmune disorders as this group has been shown to have an altered microbiome (6)
- •Those who have diabetes (6), immunodeficiencies (7), inflammatory bowel disease (6), hypercholesterolemia, as these groups have been shown to have altered gut microbiomes
- •Those who have taken oral probiotic supplements (8) within 4 weeks of starting the study
- •Given the nature of the instructions that need to be adhered to for accurate collection of samples and this data, non-English speaking individuals will be excluded from this pilot study.
- •Allergies to the tetracycline group of antibiotics
- •Those who do not fit the inclusion criteria
研究组 & 干预措施
doxycycline
Given doxycycline and assessment of gut, blood and skin
干预措施: Doxycycline (Drug)
Control
Control subjects to assess if there is baseline difference in these micro-evironments.
结局指标
主要结局
Change in the diversity of the gut microbiome before and after the treatment of doxycycline in those with acne.
时间窗: 2 years
The diversity will be evaluated by assessing the Bray-Curtis dissimilarity index and the Shannon diversity of the bacterial DNA in the gut microbiome.
Change in the diversity of the gut microbiome in those with and without acne.
时间窗: 2 years
The diversity will be evaluated by assessing the Bray-Curtis dissimilarity index and the Shannon diversity of the bacterial DNA in the gut microbiome.
次要结局
- Change in the investigator global assessment of acne(2 years)
- Change in the lesion count of inflammatory and non-inflammatory lesions(2 years)
- Change in the diversity of the skin microbiome in those with and without acne(2 years)
- Change in the diversity of the blood lipidome in those with and without acne(2 year)
- Change in the blood lipidome before and after treatment with doxycycline in those with(2 years)
- Change in the diversity of the skin microbiome before and after treatment with doxycycline in those with acne(2 years)
- Change in the diversity of the skin lipidome in those with and without acne(2 years)
- Change in the skin lipidome before and after treatment with doxycycline in those with acne(2 years)
- Change in global acne grade score(2 years)