Skin Inflammation in (Peri)Menopause: A Probiotic Intervention Proof of Concept Trial

What this trial studies

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.

Conditions in scope

• Skin Inflammation
• Immunosenescence
• Inflammation
• Skin Health
• Eczema
• Rosacea
• Acne
• Menopause

Interventions

• Lactobacillus casei Shirota (LcS) Probiotic Drink (Dietary Supplement) — Daily intake of 130 ml low-sugar fermented milk drink containing Lactobacillus casei Shirota for 8 weeks.
• Skimmed Milk Control Drink (Other) — Daily intake of 130 ml skimmed milk for 8 weeks.

Who can join

Women only · Ages 40 Years to 60 Years

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

• 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.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2026-04-28
• Primary completion: 2027-11-01
• Last update posted: 2026-05-08
• First posted: 2026-01-14

Sponsor & contact

Lead sponsor: King's College London (Other)

Collaborators: Yakult (UK & Ireland) Ltd

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Immunological age (IMM-AGE) composite scores (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…
• Serum inflammaging markers (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.

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.