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

NCT07341087 | Recruiting

• 2 other identifiers: HR-25/26-52828BB/X010821/1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

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

Keywords

Probiotics; Lactobacillus casei Shirota; Immune ageing; Gut-skin axis; Skin health; Menopausal transition

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline (Week 0) and end of intervention (Week 8).

Secondary Outcomes (19)

• Skin-related quality of life

  Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)

• Skin condition severity - participant perception

  Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)

• Skin condition severity - clinician rated (measure 1)

  Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)

• Acne severity - clinician rated (measure 2 - acne only)

  Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)

• Skin Ageing

  Baseline (Week 0), Midpoint (Week 4) and Endpoint (Week 8)

Other Outcomes (3)

• Hormone levels

  Baseline (Week 0)

• Ovarian reserve

  Baseline (Week 0)

• Fasting glucose levels

  Baseline (Week 0)

Study Arms (2)

Arm 1 - Probiotic (LcS)

EXPERIMENTAL

Daily 130 ml low-sugar Lactobacillus casei Shirota (LcS) drink for 8 weeks.

Dietary Supplement: Lactobacillus casei Shirota (LcS) Probiotic Drink

Arm 2 - Control

ACTIVE COMPARATOR

Daily 130 ml skimmed milk drink for 8 weeks.

Other: Skimmed Milk Control Drink

Interventions

Skimmed Milk Control Drink OTHER

Daily intake of 130 ml skimmed milk for 8 weeks.

Arm 2 - Control

Lactobacillus casei Shirota (LcS) Probiotic Drink DIETARY_SUPPLEMENT

Daily intake of 130 ml low-sugar fermented milk drink containing Lactobacillus casei Shirota for 8 weeks.

Arm 1 - Probiotic (LcS)

Eligibility Criteria

• Age: 40 Years - 60 Years
• Gender Eligibility Details: Participants must be individuals who are biologically female and currently experiencing the menopausal transition (peri- or postmenopause). This may include cisgender women as well as transgender men or non-binary individuals who retain female reproductive physiology and meet the study's clinical criteria.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• King's College London: lead
• Yakult (UK & Ireland) Ltd: collaborator

Study Sites (1)

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

London, London, SE1 9NH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Dermatitis; Inflammation; Eczema; Rosacea; Acne Vulgaris

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Diseases, Eczematous; Acneiform Eruptions; Sebaceous Gland Diseases

Study Officials

• Wendy Hall

  King's College London

  PRINCIPAL INVESTIGATOR

• Andrea Du Preez

  King's College London

  STUDY DIRECTOR

Central Study Contacts

Prof. Wendy Hall

CONTACT

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

Andrea Du Preez, PhD

CONTACT

andrea.du_preez@kcl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to participant group allocation.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised, parallel, open-label, proof of concept trial, with an 8-week intervention and blinded outcome assessment.

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: January 14, 2026
• Study Start: April 28, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: May 8, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)