Skin InflammationSIPPINCT07341087
Skin Inflammation in (Peri)Menopause: A Probiotic Intervention Proof of Concept Trial
A study testing Lactobacillus casei Shirota (LcS) Probiotic Drink in people with Skin Inflammation and Immunosenescence, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women only
- Conditions the study is for
- Skin Inflammation, Immunosenescence, Inflammation
- What is being tested?
- Lactobacillus casei Shirota (LcS) Probiotic Drink
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Apr 2026to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
- Have sufficient proficiency in English to complete study questionnaires and assessments.
Who cannot join
- 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.
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- 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.
- BMI <18.5kg/m2 or > 35kg/m2.
- Unintentional weight loss greater than 4 kg in the 3 months prior to enrolment.
- History of substance abuse or alcoholism (alcohol intake >50 units/week) within the last 12 months.
- Current smokers, or individuals who quit smoking in the last 6-months.
- Fasting glucose >7mmol/l (finger prick test at baseline clinic).
- Active skin infection requiring systemic antibiotics, antivirals, or antifungals within the past 4 weeks.
- Major gastrointestinal disease (e.g., inflammatory bowel disease, celiac disease, short bowel syndrome) or history of significant gastrointestinal surgery (excluding appendectomy or cholecystectomy).
- Known immunodeficiency (e.g., HIV, immunosuppressive therapy, systemic corticosteroids >10 mg/day prednisolone equivalent).
- History of malignancy or clinically significant non-malignant skin conditions within the past 5 years (except adequately treated basal cell carcinoma).
- 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).
- Women with a history of severe psychiatric illness that would limit adherence to study requirements.
- Current use of probiotics, prebiotics, or antibiotics within 4 weeks prior to baseline.
- Current use of systemic corticosteroids, or other immunosuppressive/immunomodulatory therapies within the past 3 months.
- 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.
- 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).
- 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).
- Currently using, or have used, probiotic skincare (e.g., topical creams and serums) within the past 3 months.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Andrea Du Preez, PhD contact
United Kingdom1 site, 1 recruiting
- Recruiting
Metabolic Research Unit, 4th Floor (Corridor A), Franklin-Wilkins Building, KCL.
London, London, SE1 9NH
Prof. Wendy Hall, +44 (0)20 7848 4197, wendy.hall@kcl.ac.uk
Andrea Du Preez, PhD, andrea.du_preez@kcl.ac.uk
About this study
Official title: Skin Inflammation in (Peri)Menopause: A Probiotic Intervention Proof of Concept Trial (SIPPI)
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.
Read the detailed description
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.
- 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.
- Conditions
- Skin Inflammation, Immunosenescence, Inflammation, Skin Health, Eczema, Rosacea
- Being tested
- Lactobacillus casei Shirota (LcS) Probiotic Drink, Skimmed Milk Control Drink
- Keywords
- Probiotics, Lactobacillus casei Shirota, Immune ageing, Gut-skin axis, Skin health, Menopausal transition
- Medical subject headings
- Dermatitis, Inflammation, Eczema, Rosacea, Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactobacillus casei Shirota (LcS) Probiotic DrinkDietary supplement
Daily intake of 130 ml low-sugar fermented milk drink containing Lactobacillus casei Shirota for 8 weeks.
Skimmed Milk Control DrinkOther
Daily intake of 130 ml skimmed milk for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Probiotic (LcS) | Experimental | Daily 130 ml low-sugar Lactobacillus casei Shirota (LcS) drink for 8 weeks. Receives: Dietary Supplement: Lactobacillus casei Shirota (LcS) Probiotic Drink |
| Arm 2 - Control | Active comparator | Daily 130 ml skimmed milk drink for 8 weeks. Receives: Other: Skimmed Milk Control Drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunological age (IMM-AGE) composite scores
A subset of eight immune cell types-total T cells, naïve CD4 T cells, effector memory CD4 T cells, effector memory CD8 T cells, EMRA CD8 T cells, CD28- CD8 T cells, CD57⁺ CD8 T cells, and regulatory T cells-will be used to generate a composite score ranging from 0 to 1 that reflects the degree of immune ageing. Higher scores indicate more advanced immune ageing and worse outcomes.
Measured: Baseline (Week 0) and end of intervention (Week 8).
Serum inflammaging markers
Serum cytokines including CD14, IFN-α, IFN-γ, IL-1Ra, IL-6, IL-10, TNF-α, GM-CSF, IFN-β, IL-1β, IL-4, IL-8, and IL-17.
Measured: Baseline (Week 0) and end of intervention (Week 8).
Secondary outcomes (19)
Skin-related quality of life
Health-related quality of life will be assessed using the Dermatology Life Quality Index (DLQI), a validated, self-administered questionnaire for individuals with skin conditions. The DLQI consists of 10 items, each scored from 0 ("Not at all" or "Not relevant") to 3 ("Very much"). Total scores range from 0 to 30, where 0 represents no impact on quality of life and 30 represents an extremely large negative impact. Higher scores indicate worse health-related quality of life outcomes.
Measured: Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)
Skin condition severity - participant perception
The Patient Global Assessment (PtGA) will be used to assess the participant's overall perception of the severity of their skin condition. The PtGA is a patient-reported outcome measure scored on a numeric scale ranging from 0 to 10, where 0 represents no symptoms and 10 represents the worst possible symptom severity imaginable. Higher scores indicate worse skin condition severity and worse outcomes.
Measured: Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)
Skin condition severity - clinician rated (measure 1)
For all skin conditions, severity will be assessed by a blinded clinician using standardised photographic images and the Investigator Global Assessment (IGA), scored from 0 (clear) to 4 (severe). Higher scores indicate worse outcomes.
Measured: Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)
Acne severity - clinician rated (measure 2 - acne only)
For those presenting with acne only, severity will be assessed by a blinded clinician using standardised photographic images and the Leeds Acne Grading System, with scores ranging from 0 to 10. Higher scores indicate more severe acne and worse outcomes.
Measured: Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)
Skin Ageing
Signs of skin ageing will be assessed by a blinded clinician using standardised photographic images and the Griffiths Photonumeric Scale. The Griffiths scale is a validated 9-point photonumeric grading system used to assess the severity of facial photoaging features, including wrinkling, pigmentation changes, and overall skin texture. Scores range from 0 (no photoaging) to 8 (severe photoaging), with higher scores indicating more advanced skin ageing and worse outcomes.
Measured: Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)
General wellbeing
Wellbeing will be assessed using the World Health Organization Five Well-Being Index (WHO-5), a validated, self-administered questionnaire measuring current mental wellbeing. The WHO-5 consists of five items, each scored from 0 ("At no time") to 5 ("All of the time"). Raw total scores range from 0 to 25, with higher scores indicating better wellbeing. For standardised reporting, the total score may be transformed to a scale from 0 to 100, where 0 represents the worst possible wellbeing and 100 represents the best possible wellbeing.
Measured: Baseline (Week 0) and Endpoint (Week 8)
Menopause symptoms
Menopausal symptoms will be assessed using the Menoscale, a questionnaire consisting of 20 questions about menopausal symptoms. For each symptom, participants rate the extent to which it impacts their life using a scale from 0 ("Not at all") to 5 ("Extremely"). Responses are summed to generate a total score ranging from 0 to 100. Higher scores indicate a greater burden of menopausal symptoms and a worse impact on quality of life.
Measured: Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)
Anxiety symptoms
Anxiety symptoms will be assessed using the Generalized Anxiety Disorder 7-item scale (GAD-7), a validated, self-administered questionnaire. The GAD-7 consists of seven items, each scored from 0 ("Not at all") to 3 ("Nearly every day"). Total scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms and worse outcomes.
Measured: Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)
Depressive symptoms
Depressive symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9), a validated, self-administered questionnaire. The PHQ-9 consists of nine items, each scored from 0 ("Not at all") to 3 ("Nearly every day"). Total scores range from 0 to 27, with higher scores indicating more severe depressive symptoms and worse outcomes.
Measured: Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)
Immune status
The Immune Status Questionnaire (ISQ) will be used to assess participants' perceived immune functioning. The ISQ is a validated patient-reported outcome measure consisting of seven items that evaluate the frequency of common immune-related symptoms, including common colds, diarrhoea, sudden high fever, headache, muscle and joint pain, skin problems, and coughing. Each item is rated on a 5-point Likert scale (0 = never to 4 = frequently). Item scores are summed and transformed to a total score ranging from 0 to 10, with higher scores indicating better perceived immune status (fewer symptoms) and lower scores indicating poorer immune functioning.
Measured: Baseline (Week 0) and Endpoint (Week 8)
Gastrointestinal symptoms
Gastrointestinal symptoms will be assessed using the Gastrointestinal Symptom Rating Scale (GSRS), a validated, self-administered questionnaire. The GSRS consists of multiple items assessing gastrointestinal symptoms, each scored on a Likert scale from 1 to 7. Item scores are averaged to generate a total score ranging from 1 to 7, where 1 represents no discomfort and 7 represents very severe discomfort. Higher scores indicate worse gastrointestinal symptom severity and worse outcomes.
Measured: Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)
Stool consistency
Stool form will be assessed using the Bristol Stool Form Scale (BSFS), a validated visual and descriptive scale used to classify stool consistency. The BSFS categorises stool form into seven types, ranging from Type 1 (separate hard lumps, indicating severe constipation) to Type 7 (watery, no solid pieces, indicating severe diarrhoea). Lower scores indicate harder stool consistency, and higher scores indicate looser stool consistency and worse gastrointestinal outcomes.
Measured: Baseline (Week 0) and Endpoint (Week 8)
Body weight
Body weight will be measured in kilograms (kg) using a calibrated scale. Changes in body weight will be assessed over time, with higher values indicating greater body weight.
Measured: Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)
Body Mass Index (BMI)
Body mass index (BMI) will be calculated as weight in kilograms divided by height in meters squared (kg/m²). Higher BMI values indicate greater body mass relative to height.
Measured: Baseline (Week 0), Midpoint (Week 4), Endpoint (Week 8)
Body fat percentage
Body fat percentage will be measured using a bioelectrical impedance analysis (BIA) scale and reported as a percentage (%). Higher values indicate a greater proportion of body fat.
Measured: Baseline (Week 0), Midpoint (Week 4), Endpoint (Week 8)
Waist circumference
Waist circumference will be measured in centimetres (cm) using a standardised tape measure at the midpoint between the lowest rib and the iliac crest. Higher values indicate greater central adiposity.
Measured: Baseline (Week 0), Midpoint (Week 4), Endpoint (Week 8)
Hip circumference
Hip circumference will be measured in centimetres (cm) using a standardised tape measure at the level of the widest portion of the buttocks. Higher values indicate greater hip circumference.
Measured: Baseline (Week 0), Midpoint (Week 4), Endpoint (Week 8)
Systolic Blood Pressure
Systolic blood pressure will be measured in millimetres of mercury (mmHg) using a calibrated sphygmomanometer. Higher values indicate higher systolic blood pressure and worse cardiovascular outcomes.
Measured: Baseline (Week 0), Midpoint (Week 4), Endpoint (Week 8)
Diastolic blood pressure
Diastolic blood pressure will be measured in millimetres of mercury (mmHg) using a calibrated sphygmomanometer. Higher values indicate higher diastolic blood pressure and worse cardiovascular outcomes.
Measured: Baseline (Week 0), Midpoint (Week 4), Endpoint (Week 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2026
- Study start28 Apr 2026
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin InflammationStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, parallel, open-label, proof of concept trial, with an 8-week intervention and blinded outcome assessment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Yakult (UK & Ireland) Ltd
- Responsible party
- Sponsor
- Investigators
- Wendy Hall, Principal investigator, King's College LondonAndrea Du Preez, Study director, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07341087
- Sponsor's protocol ID
- HR-25/26-52828
- Other IDs
- BB/X010821/1
- Acronym
- SIPPI
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared outside the study team because our ethics approval and participant consent do not permit external sharing of de-identified data.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin Inflammation in (Peri)Menopause: A Probiotic Intervention Proof of Concept Trial (SIPPI)
- ClinicalTrials.gov ID
- NCT07341087
- Acronym / sponsor ID
- SIPPI / HR-25/26-52828
- Conditions
- Skin Inflammation, Immunosenescence, Inflammation, Skin Health, Eczema, Rosacea
- Keywords
- Probiotics, Lactobacillus casei Shirota, Immune ageing, Gut-skin axis, Skin health, Menopausal transition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Yakult (UK & Ireland) Ltd
- Study start
- 28 Apr 2026 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 14 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised, parallel, open-label, proof of concept trial, with an 8-week intervention and blinded outcome assessment.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Probiotic (LcS) | Experimental | Dietary Supplement: Lactobacillus casei Shirota (LcS) Probiotic DrinkDaily 130 ml low-sugar Lactobacillus casei Shirota (LcS) drink for 8 weeks. |
| Arm 2 - Control | Active comparator | Other: Skimmed Milk Control DrinkDaily 130 ml skimmed milk drink for 8 weeks. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactobacillus casei Shirota (LcS) Probiotic DrinkDaily intake of 130 ml low-sugar fermented milk drink containing Lactobacillus casei Shirota for 8 weeks. | Dietary supplement | Arm 1 - Probiotic (LcS) |
| Skimmed Milk Control DrinkDaily intake of 130 ml skimmed milk for 8 weeks. | Other | Arm 2 - Control |
Primary outcome
Immunological age (IMM-AGE) composite scores
Time frame: Baseline (Week 0) and end of intervention (Week 8).
A subset of eight immune cell types-total T cells, naïve CD4 T cells, effector memory CD4 T cells, effector memory CD8 T cells, EMRA CD8 T cells, CD28- CD8 T cells, CD57⁺ CD8 T cells, and regulatory T cells-will be used to generate a composite score ranging from 0 to 1 that reflects the degree of immune ageing. Higher scores indicate more advanced immune ageing and worse outcomes.
Serum inflammaging markers
Time frame: Baseline (Week 0) and end of intervention (Week 8).
Serum cytokines including CD14, IFN-α, IFN-γ, IL-1Ra, IL-6, IL-10, TNF-α, GM-CSF, IFN-β, IL-1β, IL-4, IL-8, and IL-17.
19 secondary outcomes
Skin-related quality of life
Time frame: Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)
Skin condition severity - participant perception
Time frame: Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)
Skin condition severity - clinician rated (measure 1)
Time frame: Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)
Acne severity - clinician rated (measure 2 - acne only)
Time frame: Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)
Skin Ageing
Time frame: Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)
General wellbeing
Time frame: Baseline (Week 0) and Endpoint (Week 8)
Menopause symptoms
Time frame: Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)
Anxiety symptoms
Time frame: Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)
Depressive symptoms
Time frame: Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)
Immune status
Time frame: Baseline (Week 0) and Endpoint (Week 8)
Gastrointestinal symptoms
Time frame: Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)
Stool consistency
Time frame: Baseline (Week 0) and Endpoint (Week 8)
Body weight
Time frame: Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)
Body Mass Index (BMI)
Time frame: Baseline (Week 0), Midpoint (Week 4), Endpoint (Week 8)
Body fat percentage
Time frame: Baseline (Week 0), Midpoint (Week 4), Endpoint (Week 8)
Waist circumference
Time frame: Baseline (Week 0), Midpoint (Week 4), Endpoint (Week 8)
Hip circumference
Time frame: Baseline (Week 0), Midpoint (Week 4), Endpoint (Week 8)
Systolic Blood Pressure
Time frame: Baseline (Week 0), Midpoint (Week 4), Endpoint (Week 8)
Diastolic blood pressure
Time frame: Baseline (Week 0), Midpoint (Week 4), Endpoint (Week 8)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared outside the study team because our ethics approval and participant consent do not permit external sharing of de-identified data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrea Du Preez, PhD contact
Wendy Hall principal investigator
King's College London
Andrea Du Preez study director
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus casei Shirota (LcS) Probiotic Drink in people with Skin Inflammation and Immunosenescence, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof. Wendy Hall (+44 (0)20 7848 4197, wendy.hall@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunological age (IMM-AGE) composite scores (time frame: Baseline (Week 0) and end of intervention (Week 8).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.