NCT04596748Unknown不适用
Prospective Randomized Double-Blind Placebo-Controlled Study of Oral Probiotics on the Microbiome and Lipidome in Acne Vulgaris
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Short chain fatty acids
研究概览
简要总结
The purpose of this study is to determine how probiotics affect sebum production and gut health in those with acne vulgaris.
详细描述
Probiotics have been shown in previous pilot studies to be helpful in acne and this study aims to examine how the gut microbiome and skin biophysical properties are shifted in those with acne vulgaris. In particular, this study will assess the influence of oral spore based probiotics on the skin sebum production and will assess how probiotics influence the gut microbiome and the blood levels of short chain fatty acids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 13 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects aged 13-45
- •Subjects with acne vulgaris as diagnosed by a board-certified dermatologist,having mild-moderate acne on the face with an IGA score of 2-3 and 10+ inflammatory lesions on face and 15+ total lesions.
- •Subjects should experience new acne lesions on a recurrent basis within last 6 months
- •Must be willing to comply with all protocol requirements
- •Must be willing to have flash photo facial images taken with the imaging systems
- •Males must be willing to shave any facial hair
排除标准
- •Any systemic antibiotics used to treat acne (injected or oral)within 6 months of starting study. Any 14-day or shorter course of systemic antibiotics (injected or oral) used to treat conditions other than acne within 1 month of starting study
- •Any topical antibiotic or benzoyl peroxide within 1 month of starting study or any subject unwilling to refrain from washout of topical antibacterial or benzoyl peroxide ingredient.
- •Any oral probiotic or prebiotic supplementation within past 1 month
- •Subjects must have no history of malignancy or cancer or diagnosis of gastrointestinal inflammatory diseases, no history or diagnosis of epilepsy, no history or diagnosis of immunologic or infectious disease (e.g. hepatitis, tuberculosis, HIV or AIDS, lupus, rheumatoid arthritis)
- •Has a condition or is on medication the investigator and/or designee believe could jeopardize the safety of the subject, interfere with the evaluation, or confound the interpretation of the study results
- •Women who have been pregnant in the last three months, are pregnant, preparing to be pregnant or lactating, or post-menopausal.
- •Is participating in a concurrent clinical research study or has participated in acne or other facial study at this or any other facility in the past 4 weeks
- •Those with BMI higher than 35kg/m²
- •Those that have undergone a change in hormonally based therapies, such as but not limited to oral contraceptive pills or progesterone based pills within the last two months. Progesterone releasing IUDs and spironolactone are considered hormone-based therapy.
- •Commencement of a new diet (such as the ketogenic diet)or supplements within the 1 month prior to initiating participation, at the discretion of the investigator.
- •Use of medications that alter blood lipids, such as statins and anti-hyperlipidemic medications
- •Is participating in or has participated in acne or other facial study at this or any other facility in the past 4 weeks. Participation in survey-based studies are approved at the discretion of the investigator.
- •Has a skin disease on face, other than acne, that will interfere with image collection and assessment in the opinion of the investigator
- •Refusal to shave or remove facial hair that may interfere with image collection and assessment.
- •Severe acne or nodulocystic acne, at the discretion of the investigator
- •Use of isotretinoin within the 6 months prior to starting in study.
- •Persons unwilling to avoid the following during the 4 weeks prior and during the duration of the study: self-tanning, spa tanning, or artificial tanning.
- •Known allergy or irritation to the supplement or facial products utilized in the study
- •Current tobacco smokers, OR those that have smoked tobacco over the past year, OR a 5 year-pack year history of smoking tobacco
- •Prisoners
- •Adults unable to consent
结局指标
主要结局
Short chain fatty acids
时间窗: 12 weeks
Blood plasma
Microbiota Diversity
时间窗: 12 weeks
Evaluation of alpha diversity
Blood acetate levels
时间窗: 12 weeks
Blood plasma
次要结局
- Facial skin tone - Image based(4,8,12 weeks)
- Safety assessments for GI distress(4 weeks, 8 weeks, 12 weeks)
- Change in skin pH(4,8, and 12 weeks)
- Change in sebum excretion rate(4 weeks, 8 weeks, 12 weeks)
- Change in skin hydration(4,8 and 12 weeks)
- Facial redness - Image based(4,8,12 weeks)
- Safety assessment of acne(4, 8, 12 weeks)
- Gut microbiome changes(4 weeks and 8 weeks)
- Change in skin microbiome(12 weeks)
- Subjective assessment of the skin(4,8,12 weeks)
- Gut Microbiome Changes(4, 8, 12 weeks)
研究者
Raja Sivamani
Principal Investigator
Integrative Skin Science and Research
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Probiotic Intervention for Occasional ConstipationGut FunctionOccasional ConstipationNCT06444139Probi AB100
Unknown
不适用
Effects of Probiotics Supplementation on Intestinal Microbiome in Malignancy Pts(Get Pelvic/Abdominal Rtx)CancerNCT01706393Seoul National University Hospital26
已完成
不适用
Effect of Probiotic on the Gut Microbiota of Healthy VolunteersHealthy AdultsNCT06103253Wecare Probiotics Co., Ltd.112
已完成
不适用
The Efficacy of a Probiotic Product on Acute Upper Respiratory Tract Infections (Common Cold) in Healthy ChildrenAcute Upper Respiratory Tract Infections (Common Cold)NCT02640352Probi AB550
已完成
不适用
Probiotic Intervention for Gut FunctionGut FunctionNCT05155449Probi AB200