Skip to main content
UK clinical trials - updated daily from ClinicalTrials.gov
TrialConnect
← Back to Search
Looking for participantsNA

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

Sponsor: King's College London

NCT ID: NCT07341087

View on ClinicalTrials.gov ↗

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.

Skin InflammationImmunosenescenceInflammationSkin HealthEczemaRosaceaAcneMenopause

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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
Inclusion Criteria: 1. Female, aged 40-60 years. 2. Self-reported or clinician-diagnosed non-infectious, non-autoimmune inflammatory skin condition affecting the face (e.g., rosacea, acne, eczema). 3. Willing and able to consume a daily oral intervention (2x 65 ml probiotic drinks or skimmed milk) for 8 weeks. 4. 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. 5. Willing and able to provide a photograph of the facial area, with all images anonymised for study purposes. 6. Able to comply with study procedures, including attending clinic visits at KCL. 7. 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). 8. Capable of providing written informed consent. 9. Have sufficient proficiency in English to complete study questionnaires and assessments. Exclusion Criteria: 1. Inability or unwillingness to provide informed consent. 2. Inability or unwillingness to comply with study protocol requirements (e.g., clinic visits, sample provision, daily consumption of study drink) 3. Unwilling to record dietary intakes using handwritten diet diaries 4. Not fluent in the English language 5. Is planning on international travel during the study period 6. Current participation in another interventional clinical trial or having received an investigational/pharmaceutical product within the past 3 months. 7. Known allergy or intolerance to dairy products, skimmed milk, or probiotic drinks containing Lactobacillus species. 8. Currently pregnant, currently breastfeeding or planning to become pregnant in the next 4 months. 9. BMI \<18.5kg/m2 or \> 35kg/m2. 10. Unintentional weight loss greater than 4 kg in the 3 months prior to enrolment. 11. History of substance abuse or alcoholism (alcohol intake \>50 units/week) within the last 12 months. 12. Current smokers, or individuals who quit smoking in the last 6-months. 13. Fasting glucose \>7mmol/l (finger prick test at baseline clinic). 14. Active skin infection requiring systemic antibiotics, antivirals, or antifungals within the past 4 weeks. 15. Major gastrointestinal disease (e.g., inflammatory bowel disease, celiac disease, short bowel syndrome) or history of significant gastrointestinal surgery (excluding appendectomy or cholecystectomy). 16. Known immunodeficiency (e.g., HIV, immunosuppressive therapy, systemic corticosteroids \>10 mg/day prednisolone equivalent). 17. History of malignancy or clinically significant non-malignant skin conditions within the past 5 years (except adequately treated basal cell carcinoma). 18. Serious medical conditions that, in the opinion of the investigator, would compromise safety or interfere with study outcomes (e.g., uncontrolled diabetes, advanced cardiovascular, hepatic, or renal disease, active cancer, autoimmune conditions). 19. Women with a history of severe psychiatric illness that would limit adherence to study requirements. 20. Current use of probiotics, prebiotics, or antibiotics within 4 weeks prior to baseline. 21. Current use of systemic corticosteroids, or other immunosuppressive/immunomodulatory therapies within the past 3 months. 22. Currently receiving, or having received, phototherapy (e.g., UVB, PUVA, laser/light-based treatments, including at home treatments) for any skin condition within the past 3 months. 23. Currently receiving, or having received, systemic dermatology treatments likely to affect skin inflammation or immune response within the past 3 months (e.g., isotretinoin, methotrexate, cyclosporine, biologics such as TNF, IL-17, IL-23 or IL-4/IL-13 inhibitors). 24. Currently receiving, or having received, topical treatments likely to significantly alter skin inflammation within the past 3 months (e.g., high-potency topical corticosteroids, topical calcineurin inhibitors such as tacrolimus or pimecrolimus, topical retinoids, or photodynamic therapy). 25. Currently using, or have used, probiotic skincare (e.g., topical creams and serums) within the past 3 months. 26. Currently receiving, have undergone, or plan to undergo cosmetic skin procedures (e.g., chemical peels, laser therapy, dermal fillers, microneedling) within the 3 months prior to, or within 3 months after the first (baseline) visit. 27. Currently using, or have used, hormonal contraceptives or treatments known to exacerbate skin conditions, including Mirena (levonorgestrel-releasing intrauterine system), oral progesterone-only contraceptives (e.g., mini-pill), and synthetic progestogens (e.g., norethisterone) within the past 3 months.

Where Is This Study? (1 UK site)

Metabolic Research Unit, 4th Floor (Corridor A), Franklin-Wilkins Building, KCL.

London SE1 9NH, United Kingdom

Recruiting
Site contact (verified)
Wendy HallPrincipal Investigator
Andrea Du Preez, PhDandrea.du_preez@kcl.ac.uk

How to Get in Touch

Prof. Wendy Hall

Sponsor contact

CONTACT

+44 (0)20 7848 4197 wendy.hall@kcl.ac.uk

Andrea Du Preez, PhD

Sponsor contact

CONTACT

andrea.du_preez@kcl.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2025-12