How skin massage affects babies' skin immune system
Official title: A Randomised Controlled Trial to Investigate How Regular Skin Massage Impacts the Immune System in Early Life
Run by King's College London · NCT07228728 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 0 Months to 6 Months |
| Sex | All |
| Enrollment | 109 (estimated) |
| Sponsor | King's College London Academic / other |
| Locations | 1 site (London) |
| Status | Recruiting |
| Started | January 2, 2026 |
| Main results expected | March 30, 2027 |
| Study ends | April 30, 2027 |
| Registry record updated | February 11, 2026 |
| Trial ID | NCT07228728 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.