Skin Inflammation in (Peri)Menopause: A Probiotic Intervention Proof of Concept Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-60
SponsorKing's College London
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Lactobacillus casei Shirota (LcS) Probiotic Drink
Dietary supplementDaily intake of 130 ml low-sugar fermented milk drink containing Lactobacillus casei Shirota for 8 weeks.
Skimmed Milk Control Drink
Other interventionDaily intake of 130 ml skimmed milk for 8 weeks.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Arm 1 - Probiotic (LcS)Experimental treatment 1 intervention
Group B: Arm 2 - ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Immunological age (IMM-AGE) composite scores
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.
Time frame
Baseline (Week 0) and end of intervention (Week 8).2
Serum inflammaging markers
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.
Time frame
Baseline (Week 0) and end of intervention (Week 8).Secondary outcomes
1
Skin-related quality of life
Health-related quality of life will be assessed using the Dermatology Life Quality Index (DLQI), a validated, self-administered questionnaire for individuals with skin conditions. The DLQI consists of 10 items, each scored from 0 ("Not at all" or "Not relevant") to 3 ("Very much"). Total scores range from 0 to 30, where 0 represents no impact on quality of life and 30 represents an extremely large negative impact. Higher scores indicate worse health-related quality of life outcomes.
Time frame
Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)2
Skin condition severity - participant perception
The Patient Global Assessment (PtGA) will be used to assess the participant's overall perception of the severity of their skin condition. The PtGA is a patient-reported outcome measure scored on a numeric scale ranging from 0 to 10, where 0 represents no symptoms and 10 represents the worst possible symptom severity imaginable. Higher scores indicate worse skin condition severity and worse outcomes.
Time frame
Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)3
Skin condition severity - clinician rated (measure 1)
For all skin conditions, severity will be assessed by a blinded clinician using standardised photographic images and the Investigator Global Assessment (IGA), scored from 0 (clear) to 4 (severe). Higher scores indicate worse outcomes.
Time frame
Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)4
Acne severity - clinician rated (measure 2 - acne only)
For those presenting with acne only, severity will be assessed by a blinded clinician using standardised photographic images and the Leeds Acne Grading System, with scores ranging from 0 to 10. Higher scores indicate more severe acne and worse outcomes.
Time frame
Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)Other outcomes
1
Hormone levels
Follicle Stimulating Hormone (FSH) and oestrogen levels - to control for heterogeneity in menopausal status
Time frame
Baseline (Week 0)2
Ovarian reserve
The Stages of Reproductive Aging Workshop +10 (STRAW+10) criteria will be used to classify reproductive aging stage and to determine ovarian reserve and menopausal status based on menstrual cycle characteristics and relevant clinical information. Classification will be performed according to established STRAW+10 definitions.
Time frame
Baseline (Week 0)3
Fasting glucose levels
Fasting blood glucose levels will be measured using a finger-prick capillary blood test after an overnight fast. This will be used to screen for (and exclude those with) hyperglycaemia (\>7 mmol/L).
Time frame
Baseline (Week 0)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
King's College London
Lead sponsor
Yakult (UK & Ireland) Ltd
Collaborator
Source ClinicalTrials.gov