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
Qualifiers
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
Treatments tested in this trial
- Lactobacillus casei Shirota (LcS) Probiotic Drink
- Skimmed Milk Control Drink
Treatment groups
30 Participants
are divided into 2 treatment groupsSponsors and collaborators
King's College London
Lead sponsor
Yakult (UK & Ireland) Ltd
Collaborator
Source ClinicalTrials.gov