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New treatment option for Skin Inflammation
Official title Skin Inflammation in (Peri)Menopause: A Probiotic Intervention Proof of Concept Trial
ClinicalTrials.gov ID: NCT07341087
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 60, women only
You may be able to join 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...
- Willing and able to provide a photograph of the facial area, with all images anonymised for study purposes.
You likely can't join 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 treatment clinical trial or having received an investigational/pharmaceutical product within the past 3 months.
See the full eligibility criteria
Who can 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.
- 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.
What rules you out
- 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 treatment 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 \ 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...
- 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...
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- London, London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 40 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, London, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.