An interventional study of Lactobacillus casei Shirota (LcS) Probiotic Drink and Skimmed Milk Control Drink in Skin Inflammation, Immunosenescence and Inflammation, sponsored by King's College London. Recruiting at 1 site in United Kingdom. Open to female participants aged 40 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by King's College London · Not applicable, Interventional, and Basic science
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.
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:
Study design
Measurements:
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.
503 studies on the registry are indexed under Eczema; 89 are open to participants now.
This study's planned enrollment of 30 is below the median of 91 across 401 interventional studies indexed under Eczema.
Browse Eczema studies →King's College London is the lead sponsor of 520 studies on the registry; 126 are open to participants now.
Compared within Eczema, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Dermatitis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Daily 130 ml low-sugar Lactobacillus casei Shirota (LcS) drink for 8 weeks.
Dietary Supplement: Lactobacillus casei Shirota (LcS) Probiotic Drink
Daily 130 ml skimmed milk drink for 8 weeks.
Other: Skimmed Milk Control Drink
Daily intake of 130 ml low-sugar fermented milk drink containing Lactobacillus casei Shirota for 8 weeks.
Daily intake of 130 ml skimmed milk for 8 weeks.
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.
Time frame: 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.
Time frame: Baseline (Week 0) and end of intervention (Week 8).
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (Week 0), Midpoint (Week 4), Endpoint (Week 8)
Hormone levels
Follicle Stimulating Hormone (FSH) and oestrogen levels - to control for heterogeneity in menopausal status
Time frame: Baseline (Week 0)
Ovarian reserve
The Stages of Reproductive Aging Workshop +10 (STRAW+10) criteria will be used to classify reproductive aging stage and to determine ovarian reserve and menopausal status based on menstrual cycle characteristics and relevant clinical information. Classification will be performed according to established STRAW+10 definitions.
Time frame: Baseline (Week 0)
Fasting glucose levels
Fasting blood glucose levels will be measured using a finger-prick capillary blood test after an overnight fast. This will be used to screen for (and exclude those with) hyperglycaemia (\>7 mmol/L).
Time frame: Baseline (Week 0)
Plan to share: 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.
No publications or documents are linked to this record.
Started Apr 2026 (actual). Primary completion is estimated for Nov 2027, 18 months after the start.
Of 45 non-industry interventional studies with no phase under Eczema, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 44. This study's planned 18 months is close to that.
Counting every sponsor, half of 78 studies reached it within 11 months; a quarter within 4 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
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