Actively Recruiting
Skin Inflammation in (Peri)Menopause: A Probiotic Intervention Proof of Concept Trial (SIPPI)
Led by King's College London · Updated on 2026-05-08
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
K
King's College London
Lead Sponsor
Y
Yakult (UK & Ireland) Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to explore whether a daily probiotic drink containing Lactobacillus casei Shirota (LcS) can support immune function and reduce inflammation in women during the menopausal transition. This period, typically affecting women aged 40 to 60, involves hormonal changes that can impact the immune system, gut health, and skin, potentially leading to conditions such as eczema, acne, or rosacea. The study evaluates a safe, non-hormonal probiotic approach as an alternative to hormone replacement therapy for improving immune and skin health. Participants will be randomly assigned to consume either a low-sugar LcS probiotic drink or a skimmed milk control drink daily for eight weeks. Each participant will take 130 ml per day of their assigned drink. The trial is open-label with blinded outcome assessments and includes peri- and postmenopausal women with inflammatory skin conditions. Measurements include immune function, inflammation markers, skin health, hormone levels, and wellbeing. Stool and skin samples will also be collected for future research but not analyzed in this trial. Throughout the study, participants will attend clinic visits for blood tests, skin assessments, photographs, and questionnaires at baseline, midpoint, and endpoint. Researchers will assess composite immune age scores, inflammatory markers, skin condition severity, skin aging, and symptoms related to menopause, anxiety, depression, and general wellbeing. Body measurements and blood pressure will also be monitored. The total participation duration is eight weeks, with evaluations at weeks 0, 4, and 8 to monitor changes and safety.
CONDITIONS
Brief Title
Skin Inflammation in (Peri)Menopause: A Probiotic Intervention Proof of Concept Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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).
- Able to provide a photograph of the facial area, with all images anonymised.
- Able to comply with study procedures, including attending clinic visits.
- Have access to a refrigerator at home for safe storage of study products.
- Capable of providing written informed consent.
- Sufficient proficiency in English to complete study questionnaires and assessments.
You will not qualify if you...
- Unable or unwilling to provide informed consent.
- Unable or unwilling to comply with study protocol requirements.
- Unwilling to record dietary intakes using handwritten diet diaries.
- Not fluent in English.
- Planning international travel during the study period.
- Currently participating in another interventional trial or received investigational/pharmaceutical product in past 3 months.
- Known allergy or intolerance to dairy products, skimmed milk, or probiotic drinks containing Lactobacillus species.
- Currently pregnant, breastfeeding, or planning pregnancy in next 4 months.
- BMI less than 18.5 or greater than 35 kg/m2.
- Unintentional weight loss over 4 kg in past 3 months.
- History of substance abuse or alcoholism (alcohol intake over 50 units/week) in last 12 months.
- Current smokers or quit smoking in last 6 months.
- Fasting glucose over 7 mmol/l.
- Active skin infection requiring systemic antibiotics, antivirals, or antifungals in past 4 weeks.
- Major gastrointestinal disease or significant gastrointestinal surgery.
- Known immunodeficiency or immunosuppressive therapy.
- History of malignancy or significant skin conditions in past 5 years (except treated basal cell carcinoma).
- Serious medical conditions that may affect safety or study outcomes.
- History of severe psychiatric illness limiting study adherence.
- Current use of probiotics, prebiotics, or antibiotics within 4 weeks prior to baseline.
- Current use of systemic corticosteroids or immunomodulatory therapies within 3 months.
- Recent phototherapy or systemic dermatology treatments within 3 months.
- Recent use of topical treatments or probiotic skincare affecting inflammation within 3 months.
- Recent or planned cosmetic skin procedures within 3 months before or after baseline visit.
- Recent use of hormonal contraceptives or skin-exacerbating treatments within 3 months.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants consume a daily 130 ml drink either containing the probiotic Lactobacillus casei Shirota or skimmed milk for 8 weeks to assess effects on immune function and skin health.
Visits at baseline, midpoint (Week 4), and end of intervention (Week 8)
Trial Site Locations
Total: 1 location
1
Metabolic Research Unit, 4th Floor (Corridor A), Franklin-Wilkins Building, KCL.
London, London, United Kingdom, SE1 9NH
Actively Recruiting
Research Team
P
Prof. Wendy Hall
A
Andrea Du Preez, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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