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

Study acronym: SIPPI
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Start date changed from estimate of Apr 3, 2026 to Apr 28, 2026v4 Show 4 more changesShow less
    • Eligibility criteria shortened, about 30 words
    • Secondary endpoints revised (19)
    • Study description expanded, about 14 words
    • Study title revised
  2. Recruitment openedv3 Show 5 more changesShow less
    • Start date: Mar 9, 2026 to Apr 3, 2026
    • Eligibility criteria shortened, about 15 words
    • Secondary endpoints: 18 to 19
    • Site details revised
    • Study description expanded, about 4 words
  3. Start date: Jan 5, 2026 to Mar 9, 2026
    • Primary and study completion dates: Oct 1, 2027 to Nov 1, 2027
    • Secondary endpoints: details revised at 1 of 18 entries
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07341087
Lead Sponsor King's College London
Collaborators: Yakult (UK & Ireland) Ltd
Conditions
(from sponsor)		 Skin Inflammation, Immunosenescence, Inflammation, Skin Health, Eczema, Rosacea, Acne, Menopause
Related terms Acne Vulgaris, Dermatitis, Eczema, Inflammation, Rosacea
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov