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Clinical Trials in the UK / NCT07719309
Recruiting Observational

Exploratory Study of Peristomal and Non-Peristomal Skin Barrier Characteristics in People With a Stoma

NCT07719309 · tracked via the Priya Life Science UK tracker
Sponsor
Salts Healthcare
Phase
Observational
Started
2026-09
Last updated
2026-10-09

Condition(s) studied

Colostomy - StomaIleostomy - StomaUrostomy

Study summary

The purpose of this exploratory study is to obtain preliminary data on peristomal and non-peristomal skin barrier characterisation in people living with a stoma. The main questions it aims to answer are:

* Is there a difference/similarity in skin barrier characterisation of peristomal and non-peristomal skin in people living with a stoma?
* Is there a difference/similarity in peristomal skin barrier function of different stoma types (colostomy, ileostomy and urostomy)?
* Does a stoma type/function, influence skin barrier characterisation of peristomal skin?

Participants will:

* Attend a 1-hour study appointment
* Undergo non-invasive skin procedures

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adult 18 years or over * Have a stoma (colostomy, ileostomy or urostomy) * Have healthy peristomal skin * Have the ability to provide informed consent * Are independently mobile * Can stop using any stoma paste, cream, sprays or lotions on peristomal skin 1 day (24hrs) prior to the study appointment * Are independent with stoma care management * Are able to attend study appointment in Birmingham, UK Exclusion Criteria: * Have a current skin condition, such as eczema, psoriasis, or infection around the skin test site areas * Have bleeding or broken peristomal skin * Are currently taking any of the following medications: steroids, nicotine patches, acne medication (e.g., Accutane), any medication know to affect the properties of the skin * Use patches on your abdomen, such as HRT patches * Are receiving or have had radiotherapy or chemotherapy in the last 2 months * Are taking or have had antibiotic treatment in the last 4 weeks * Are currently receiving any stoma care treatment under a stoma care nurse specialist * Have tattoos in the skin test site areas * Are pregnant * Have excessive hair on your abdomen * Have participated in another skin testing study within the last 8 weeks

Primary outcome measure(s)

  • Assessment description of skin microbial composition of peristomal and non-peristomal skin — Study appointment (1 hour)
    Each participant will provide four skin swab samples for microbiome profiling: two swabs from the peristomal (experimental) test site area and two swabs from the non-peristomal (control) test site area, on the opposite side of the abdomen. To Identify microbial species, present in peristomal and non-peristomal area using Metagenomic Shotgun Sequencing
  • Assessment of skin barrier chemical composition including water (mass-%), ceramides & fatty acids urea, lactate, protein, natural moisturising factors (NMF) and stratum corneum (SC) thickness of peristomal and non-peristomal skin — Study Appointment (1 hour)
    6 High Wavenumber profiles of water (mass%) and SC thickness (Microns) and 6 Fingerprint profiles of ceramides \& fatty acids urea, lactate, protein and natural moisturising factors (NMF) from peristomal skin (experimental) test site area and non-peristomal (control) skin test site area, using the Raman spectrometer
  • Biophysical skin properties including Transepidermis water loss (TEWL), redness and skin colour, elasticity, sebum and pH of peristomal and non-peristomal skin — Study Appointment (1 hour)
    Measurement of Transepidermal water loss (TEWL) with Tewameter, skin colour (melanin) and skin redness (erythema) with Mexameter, elasticity and firmness with Cutometer, sebum level with Subumeter and pH with pH Meter from peristomal area (experimental) skin test and non-peristomal (control) skin test area

Trial sites (1)

FacilityCityRegionStatus
Salts Healthcare Birmingham United Kingdom Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07719309 on ClinicalTrials.gov ↗ ← All trials in the UK