Probiotic drink for skin inflammation during the menopausal transition

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

This study will test whether a daily Lactobacillus casei Shirota probiotic drink can reduce inflammation and improve immune and skin health in women aged 40–60 going through the menopausal transition with inflammatory facial skin conditions.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 40 Years to 60 Years
• Sex: Female
• Sponsor: King's College London (Academic / other)
• Drugs / interventions: methotrexate
• Locations: 1 site (London, London)
• Trial ID: NCT07341087 on ClinicalTrials.gov

What this trial studies

Women aged 40–60 with non-infectious inflammatory facial skin conditions will consume either a low-sugar Lactobacillus casei Shirota (LcS) probiotic drink or a skimmed milk control every day for eight weeks. The trial collects blood, skin and stool samples, facial photographs, and questionnaire data at baseline and after eight weeks to measure markers of immune ageing, inflammation, skin health, wellbeing, and hormone levels. The intervention is provided by Yakult in collaboration with King's College London and participants must be able to attend clinic visits in London and store the product at home. Results will show whether a short daily probiotic regimen impacts immune and skin markers during the menopausal transition.

Who should consider this trial

Good fit: Women aged 40–60 undergoing the menopausal transition who have self-reported or clinician-diagnosed non-infectious inflammatory facial skin conditions and can take a daily drink and provide blood, skin and stool samples are ideal candidates.

Not a fit: People with infectious or autoimmune skin diseases, those outside the 40–60 age range, or those unable/unwilling to provide required samples or follow storage and visit requirements are unlikely to benefit from this specific protocol.

Why it matters

Potential benefit: If successful, this could offer a safe, non-hormonal way to reduce inflammation and support immune and skin health during the menopausal transition.

How similar studies have performed: Lactobacillus casei Shirota has shown anti-inflammatory and immune-supporting effects in other adult populations, but using LcS specifically for menopausal immune ageing and inflammatory facial skin conditions is novel.

Eligibility 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 this trial is running

London, London

• Metabolic Research Unit, 4th Floor (Corridor A), Franklin-Wilkins Building, KCL. — London, London, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Wendy Hall — King's College London
• Study coordinator: Prof. Wendy Hall

Conditions Skin Inflammation; Immunosenescence; Inflammation; Skin Health; Eczema; Rosacea; Acne; Menopause