NCT07341087

Skin Inflammation in Perimenopause: A Probiotic Intervention Proof of Concept Trial

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: King's College London · Academic / Other
• Sex: Female
• Age: 40 Years – 50 Years
• Healthy volunteers: Not accepted

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 perimenopause. 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 acne. 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 perimenopause.

Detailed description

Research Question: Can a daily probiotic drink help reduce immune system ageing and improve inflammatory skin conditions, such as acne, in women going through perimenopause? Background Perimenopause is the transition before menopause, usually affecting women aged 40-50. 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 perimenopausal women, who are particularly vulnerable to immune system changes and inflammatory skin conditions. Aims and Hypothesis Aim: To explore whether an oral probiotic Lactobacillus casei Shirota (LcS) can modulate immunological age markers in perimenopausal women with acne. Hypothesis: Consuming 130 ml/day of a low-sugar probiotic (LcS) drink for 8 weeks will significantly reduce inflammation in perimenopausal women with acne compared to 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: Perimenopausal women aged 40-50 years with self-reported or clinically diagnosed acne. * 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 Perimenopause 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 perimenopause.

Conditions

• Acne Vulgaris
• Perimenopause
• Skin Inflammation
• Immunosenescence
• Inflammation

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactobacillus casei Shirota (LcS) Probiotic Drink	Daily intake of 130 ml low-sugar fermented milk drink containing Lactobacillus casei Shirota for 8 weeks.
OTHER	Skimmed Milk Control Drink	Daily intake of 130 ml skimmed milk for 8 weeks.

Timeline

• Start date: 2026-04-03
• Primary completion: 2027-11-01
• Completion: 2027-11-01
• First posted: 2026-01-14
• Last updated: 2026-03-30

Locations

1 site across 1 country: United Kingdom