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

Sponsor
King's College London
Study ID
NCT07341087
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
40 Years - 60 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

First listed
Jan 14, 2026
Start date
Apr 28, 2026
Status verified
Dec 2025
Primary completion
Nov 1, 2027
Completion
Nov 1, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Arm 1 - Probiotic (LcS)
    Daily 130 ml low-sugar Lactobacillus casei Shirota (LcS) drink for 8 weeks.
  • Active Comparator: Arm 2 - Control
    Daily 130 ml skimmed milk drink for 8 weeks.

Primary Outcome Measure

Immunological age (IMM-AGE) composite scores [ Time Frame: Baseline (Week 0) and end of intervention (Week 8). ]

Central Contacts

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