Not Yet RecruitingNot Applicable

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

United Kingdom108 participantsStarted 2026-09

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 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

Timeframe: 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

Timeframe: Study Appointment (1 hour)

Trial details

NCT IDNCT07719309

SponsorSalts Healthcare

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2028-05

Contact for this trial

Samantha Jarvis

01213332015 samantha.jarvis@salts.co.uk

View on ClinicalTrials.gov More Colostomy - Stoma trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: Study appointment (1 hour)

Timeframe: 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

Timeframe: Study Appointment (1 hour)