At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Lactobacillus casei Shirota (LcS) Probiotic Drink (supplement), Skimmed Milk Control Drink (other)
- How long the study runs
- Study runs about 19 months (dates as stated)
- About the drug or intervention
- Lactobacillus casei Shirota (LcS) Probiotic Drink — 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.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 40 Years to 60 Years
- Who
- Female
- Number of participants
- 30
- Started
- 2026-04-28
- Last checked
- 2025-12
Plain English Summary
What is this study?
- • Testing a new treatment for skin inflammation
- • NA - 30 participants
- • 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
Who can take part?
- • Ages 40 Years to 60 Years
- • Diagnosed with skin inflammation
- • Female only
Where?
- • London - Metabolic Research Unit, 4th Floor (Corridor A), Franklin-Wilkins Building, KCL.
This is a simplified summary. Always discuss with your doctor before making any decisions.
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.
More detail
Research Question: Can a daily probiotic drink help reduce immune system ageing and improve inflammatory skin conditions in women going through menopause? Background The menopausal transition usually affects women aged 40-60. During this time, hormone levels, especially oestrogen, fluctuate and gradually decline. These changes can affect the immune system, making it more prone to inflammation and less effective over time. Lower oestrogen can also affect the skin, leading to dryness, irritation, or acne. It can change the balance of bacteria in the gut and on the skin, which may worsen inflammation and overall health. While hormone replacement therapy can help some symptoms, it is not suitable for all women. Currently, there is little research on safe, non-hormonal ways to support the gut, immune system, and skin together. One promising approach is using probiotics - beneficial bacteria that can improve gut health and reduce inflammation. Lactobacillus casei Shirota (LcS) is a probiotic that has shown anti-inflammatory and immune-supporting effects in other adults. However, it has not been studied in menopausal women, who are particularly vulnerable to immune system changes and inflammatory skin conditions. Aims and Hypothesis Aim: To investigate whether the oral probiotic Lactobacillus casei Shirota (LcS) can influence markers of immunological ageing in women undergoing the menopausal transition who are experiencing skin conditions. Hypothesis: Consuming 130 ml/day of a low-sugar probiotic (LcS) drink for 8 weeks will significantly reduce inflammation in women undergoing the menopausal transition with skin conditions, compared with a 130 ml/day skimmed milk control. Objectives Primary Objective: To determine if daily LcS consumption can improve immune function, measured using a composite "immune age" score (IMM-AGE) that reflects overall immune health and inflammation. Secondary Objectives: * To look at self-reported skin health, immune status, general wellbeing, and gut health. * To assess skin inflammation and signs of ageing through clinician assessments and images. * To measure hormone levels (oestrogen and FSH). Study design * Trial Design: Randomised, parallel, open-label, proof of concept trial, with an 8-week intervention and blinded outcome assessment. * Participants: Peri- and postmenopausal women aged 40-60 years with self-reported or clinically diagnosed non-infectious, non-autoimmune skin conditions. * Intervention: Daily 130 ml low-sugar LcS probiotic drink for 8 weeks. * Comparison: Daily 130 ml skimmed milk (control) for 8 weeks. Measurements: * Immune function (IMM-AGE) * Blood markers of inflammation (cytokines including CD14, IFN-α, IFN-γ, IL1Ra, IL-6, IL-10, TNF-α, GM-CSF, IFN-β, IL1β, IL-4, IL-8, IL-17) and hormones (oestrogen and follicle stimulating hormone \[FSH\] levels) * Skin health and ageing * Self-reported wellbeing, immune status, and gut health Stool and skin samples will also be collected for future research, but these will not be analysed in this trial. 5\. Why This Study Matters The menopausal transition is a time of rapid biological change that can affect immunity and skin health. This trial will test a safe, non-hormonal approach to support the immune system, reduce inflammation, and improve skin health in midlife women. The results will help guide future research and may inform practical strategies to improve wellbeing during menopause.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 40 Years - 60 Years
- Who can join: Female only
What the study is looking for
- ✓Female, aged 40-60 years.
- ✓Self-reported or clinician-diagnosed non-infectious, non-autoimmune inflammatory skin condition affecting the face...
- ✓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 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.
Who cannot take part
- ✗Inability or unwillingness to provide agreement to take part.
- ✗Inability or unwillingness to comply with study protocol requirements (e.g., clinic visits, sample provision, daily...
- ✗Unwilling to record dietary intakes using handwritten diet diaries
- ✗Not fluent in the English language
- ✗Is planning on international travel during the study period
See the full criteria
Where Is This Study? (1 UK site)
Metabolic Research Unit, 4th Floor (Corridor A), Franklin-Wilkins Building, KCL.
London SE1 9NH, United Kingdom
How to Get in Touch
Prof. Wendy Hall
Sponsor contactCONTACT
Andrea Du Preez, PhD
Sponsor contactCONTACT
