Skin Inflammation in (Peri)Menopause: A Probiotic Intervention Proof of Concept Trial (NCT07341087) | Clinical Trial Compass
RecruitingNot Applicable
Skin Inflammation in (Peri)Menopause: A Probiotic Intervention Proof of Concept Trial
United Kingdom30 participantsStarted 2026-04-28
Plain-language summary
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.
Who can participate
Age range40 Years – 60 Years
SexFEMALE
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Inclusion criteria
✓. 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.
Exclusion criteria
What they're measuring
1
Immunological age (IMM-AGE) composite scores
Timeframe: Baseline (Week 0) and end of intervention (Week 8).
2
Serum inflammaging markers
Timeframe: Baseline (Week 0) and end of intervention (Week 8).
. 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.