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 range
40 Years – 60 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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).
. 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.