Skin Inflammation in (Peri)Menopause: A Probiotic Intervention Proof of Concept Trial (SIPPI)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Immunological age (IMM-AGE) composite scores
研究概览
简要总结
This study will explore whether a daily probiotic drink containing Lactobacillus casei Shirota (LcS) can help improve immune function and reduce inflammation in women going through the menopausal transition. Hormonal changes during this stage of life can affect the immune system, gut health, and skin, sometimes leading to increased inflammation or conditions such as eczema, acne or rosacea.
Participants will consume either a low-sugar LcS probiotic drink or a skimmed milk control drink every day for eight weeks. The study will assess markers of immune ageing, inflammation, skin health, wellbeing, and hormone levels. The results will help determine whether a safe, non-hormonal probiotic approach may support immune and skin health during the menopausal transition.
详细描述
Research Question: Can a daily probiotic drink help reduce immune system ageing and improve inflammatory skin conditions in women going through menopause?
Background
The menopausal transition usually affects women aged 40-60. During this time, hormone levels, especially oestrogen, fluctuate and gradually decline. These changes can affect the immune system, making it more prone to inflammation and less effective over time.
Lower oestrogen can also affect the skin, leading to dryness, irritation, or acne. It can change the balance of bacteria in the gut and on the skin, which may worsen inflammation and overall health.
While hormone replacement therapy can help some symptoms, it is not suitable for all women. Currently, there is little research on safe, non-hormonal ways to support the gut, immune system, and skin together. One promising approach is using probiotics - beneficial bacteria that can improve gut health and reduce inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors will be blinded to participant group allocation.
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, aged 40-60 years.
- •Self-reported or clinician-diagnosed non-infectious, non-autoimmune inflammatory skin condition affecting the face (e.g., rosacea, acne, eczema).
- •Willing and able to consume a daily oral intervention (2x 65 ml probiotic drinks or skimmed milk) for 8 weeks.
- •Willing and able to provide sufficient blood, skin and stool samples at baseline and end-of-study (Week 8). Participants unable to provide adequate blood sample volumes will not be able to start the intervention.
- •Willing and able to provide a photograph of the facial area, with all images anonymised for study purposes.
- •Able to comply with study procedures, including attending clinic visits at KCL.
- •Have access to a refrigerator at home and be able to store the study product(s) safely after collection (i.e., travel time allows safe storage).
- •Capable of providing written informed consent.
- •Have sufficient proficiency in English to complete study questionnaires and assessments.
排除标准
- •Inability or unwillingness to provide informed consent.
- •Inability or unwillingness to comply with study protocol requirements (e.g., clinic visits, sample provision, daily consumption of study drink)
- •Unwilling to record dietary intakes using handwritten diet diaries
- •Not fluent in the English language
- •Is planning on international travel during the study period
- •Current participation in another interventional clinical trial or having received an investigational/pharmaceutical product within the past 3 months.
- •Known allergy or intolerance to dairy products, skimmed milk, or probiotic drinks containing Lactobacillus species.
- •Currently pregnant, currently breastfeeding or planning to become pregnant in the next 4 months.
- •BMI <18.5kg/m2 or > 35kg/m
- •Unintentional weight loss greater than 4 kg in the 3 months prior to enrolment.
- •History of substance abuse or alcoholism (alcohol intake >50 units/week) within the last 12 months.
- •Current smokers, or individuals who quit smoking in the last 6-months.
- •Fasting glucose >7mmol/l (finger prick test at baseline clinic).
- •Active skin infection requiring systemic antibiotics, antivirals, or antifungals within the past 4 weeks.
- •Major gastrointestinal disease (e.g., inflammatory bowel disease, celiac disease, short bowel syndrome) or history of significant gastrointestinal surgery (excluding appendectomy or cholecystectomy).
- •Known immunodeficiency (e.g., HIV, immunosuppressive therapy, systemic corticosteroids >10 mg/day prednisolone equivalent).
- •History of malignancy or clinically significant non-malignant skin conditions within the past 5 years (except adequately treated basal cell carcinoma).
- •Serious medical conditions that, in the opinion of the investigator, would compromise safety or interfere with study outcomes (e.g., uncontrolled diabetes, advanced cardiovascular, hepatic, or renal disease, active cancer, autoimmune conditions).
- •Women with a history of severe psychiatric illness that would limit adherence to study requirements.
- •Current use of probiotics, prebiotics, or antibiotics within 4 weeks prior to baseline.
- •Current use of systemic corticosteroids, or other immunosuppressive/immunomodulatory therapies within the past 3 months.
- •Currently receiving, or having received, phototherapy (e.g., UVB, PUVA, laser/light-based treatments, including at home treatments) for any skin condition within the past 3 months.
- •Currently receiving, or having received, systemic dermatology treatments likely to affect skin inflammation or immune response within the past 3 months (e.g., isotretinoin, methotrexate, cyclosporine, biologics such as TNF, IL-17, IL-23 or IL-4/IL-13 inhibitors).
- •Currently receiving, or having received, topical treatments likely to significantly alter skin inflammation within the past 3 months (e.g., high-potency topical corticosteroids, topical calcineurin inhibitors such as tacrolimus or pimecrolimus, topical retinoids, or photodynamic therapy).
- •Currently using, or have used, probiotic skincare (e.g., topical creams and serums) within the past 3 months.
- •Currently receiving, have undergone, or plan to undergo cosmetic skin procedures (e.g., chemical peels, laser therapy, dermal fillers, microneedling) within the 3 months prior to, or within 3 months after the first (baseline) visit.
- •Currently using, or have used, hormonal contraceptives or treatments known to exacerbate skin conditions, including Mirena (levonorgestrel-releasing intrauterine system), oral progesterone-only contraceptives (e.g., mini-pill), and synthetic progestogens (e.g., norethisterone) within the past 3 months.
研究组 & 干预措施
Arm 2 - Control
Daily 130 ml skimmed milk drink for 8 weeks.
干预措施: Skimmed Milk Control Drink (Other)
Arm 1 - Probiotic (LcS)
Daily 130 ml low-sugar Lactobacillus casei Shirota (LcS) drink for 8 weeks.
干预措施: Lactobacillus casei Shirota (LcS) Probiotic Drink (Dietary Supplement)
结局指标
主要结局
Immunological age (IMM-AGE) composite scores
时间窗: Baseline (Week 0) and end of intervention (Week 8).
A subset of eight immune cell types-total T cells, naïve CD4 T cells, effector memory CD4 T cells, effector memory CD8 T cells, EMRA CD8 T cells, CD28- CD8 T cells, CD57⁺ CD8 T cells, and regulatory T cells-will be used to generate a composite score ranging from 0 to 1 that reflects the degree of immune ageing. Higher scores indicate more advanced immune ageing and worse outcomes.
Serum inflammaging markers
时间窗: Baseline (Week 0) and end of intervention (Week 8).
Serum cytokines including CD14, IFN-α, IFN-γ, IL-1Ra, IL-6, IL-10, TNF-α, GM-CSF, IFN-β, IL-1β, IL-4, IL-8, and IL-17.
次要结局
- Acne-related quality of life(Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8))
- Acne severity - participant perception(Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8))
- Acne severity - clinician rated (measure 1)(Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8))
- Acne severity - clinician rated (measure 2)(Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8))
- General wellbeing(Baseline (Week 0) and Endpoint (Week 8))
- Menopause symptoms(Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8))
- Anxiety symptoms(Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8))
- Depressive symptoms(Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8))
- Gastrointestinal symptoms(Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8))
- Body Mass Index (BMI)(Baseline (Week 0), Midpoint (Week 4), Endpoint (Week 8))
- Stool consistency(Baseline (Week 0) and Endpoint (Week 8))
- Body weight(Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8))
- Body fat percentage(Baseline (Week 0), Midpoint (Week 4), Endpoint (Week 8))
- Waist circumference(Baseline (Week 0), Midpoint (Week 4), Endpoint (Week 8))
- Hip circumference(Baseline (Week 0), Midpoint (Week 4), Endpoint (Week 8))
- Systolic Blood Pressure(Baseline (Week 0), Midpoint (Week 4), Endpoint (Week 8))
- Diastolic blood pressure(Baseline (Week 0), Midpoint (Week 4), Endpoint (Week 8))
- Skin Ageing(Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8))