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

NCT07719309 | Not Yet Recruiting

• 1 other identifier: 26/HRA/1622
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Colostomy - Stoma; Ileostomy - Stoma; Urostomy

Keywords

Peristomal skin; Skin Barrier Characterisation; People Living with a Stoma; Exploratory Study; Peristomal Skin Health

Outcome Measures

Primary Outcomes (3)

• Assessment description of skin microbial composition of peristomal and non-peristomal skin

  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

  Study appointment (1 hour)

• 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

  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

  Study Appointment (1 hour)

• Biophysical skin properties including Transepidermis water loss (TEWL), redness and skin colour, elasticity, sebum and pH of peristomal and non-peristomal skin

  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

  Study Appointment (1 hour)

Secondary Outcomes (3)

• Compare microbiota analysis of each peristomal skin stoma type (Colostomy, Ileostomy and Urostomy)

  Study Appointment (1 hour)

• Compare skin barrier chemical composition including water (mass-%), ceramides & fatty acids urea, lactate, protein, natural moisturising factors (NMF) and stratum corneum (SC) thickness of each stoma type peristomal skin

  Study Appointment (1 hour)

• Compare biophysical skin properties including Transepidermis water loss (TEWL), redness and skin colour, elasticity, sebum and pH of stoma type (Colostomy, Ileostomy and Urostomy) peristomal skin

  Study Appointment (1 hour)

Other Outcomes (1)

• Correlation between peristomal skin barrier characterisation and stoma type/function and management

  Study Appointment (1 hour)

Study Arms (1)

People Living with a Stoma

Colostomy, Ileostomy, Urostomy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be recruited from Birmingham UK and the surrounding areas (up to a distance of 150 miles)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Salts Healthcare: lead

Study Sites (1)

Salts Healthcare

Birmingham, B7 4AA, United Kingdom

Location

Study Officials

• Mireille Hamson

  Salts Healthcare

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samantha Jarvis

CONTACT

01213332015; samantha.jarvis@salts.co.uk

Mireille Hamson

CONTACT

mireille.hamson@salts.co.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 22, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)