How skin massage affects babies' skin immune system
A Randomised Controlled Trial to Investigate How Regular Skin Massage Impacts the Immune System in Early Life
We will test whether regular skin massage in healthy term babies up to 6 months changes skin immune signals and barrier function over an 8-week period.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 109 (estimated) |
| Ages | 0 Months to 6 Months |
| Sex | All |
| Sponsor | King's College London Academic / other |
| Locations | 1 site (London) |
| Trial ID | NCT07228728 on ClinicalTrials.gov |
What this trial studies
This interventional study will compare groups of healthy term infants who receive daily, bi-weekly, or no skin massage over eight weeks, with measurements taken at St Thomas' Hospital. A pilot phase with the first nine infants will optimize a non‑invasive interstitial fluid (ISF) device for sampling skin cytokines. Main outcomes include changes in pro‑inflammatory cytokines in ISF, skin barrier measurements, and skin bacterial diversity. Parents will attend clinic visits for device sampling and barrier tests while caregivers perform the prescribed massage regimen at home.
Who should consider this trial
Good fit: Healthy, term infants up to 6 months old whose parents or guardians can give written consent and follow the study procedures are ideal candidates.
Not a fit: Babies with a personal history of inflammatory skin disease (such as atopic dermatitis), those born preterm, or those already enrolled in another interventional study are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the results could show that simple, regular skin massage supports healthy skin immune signaling and barrier development in early life, informing caregiver practices.
How similar studies have performed: Previous work suggests massage can improve blood flow and caregiver bonding and may affect immune outcomes, but direct effects on the skin's cutaneous immune response and barrier in infants have not been studied and this approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Healthy babies born at term up to 6 months old 2. Ability of parents/guardians/caregivers to provide written informed consent for study participation 3. Willingness of parents/guardians/caregivers to comply with all study requirements. Exclusion Criteria: 1. Parents/guardians/caregivers unable to give informed consent. 2. Personal history of inflammatory skin disease (in particular atopic dermatitis) 3. Active involvement in another interventional research study
Where this trial is running
London
- St. Thomas' Hospital — London, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Carsten Flohr — Guy's and St Thomas' NHS Foundation Trust
- Study coordinator: Preeti Khurana
- Email: gstt.cutie.study@nhs.net
- Phone: 020 7188 7188
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.