Impact of the Microbiome on outcomes following HAUL transplantation
Research type
Research Study
Full title
Do changes in the Microbiome Correlate with Outcomes Following Hand and Upper Limb Transplantation?
IRAS ID
332621
Contact name
David Alan Leonard
Contact email
Sponsor organisation
Leeds Teaching Hospitals NHS Trust
Duration of Study in the UK
0 years, 5 months, 31 days
Research summary
Upper limb loss through trauma or disease can have a severe impact on an individual’s psychology, function and quality of life. The use of a prosthesis can be a helpful treatment for many upper limb amputees, but for those who don't find them suitable, a hand transplant provides an alternative option and can prove to be life-changing.
As with all transplants, hand transplant patients must take lifelong immunosuppressant medication. These medicines lower the body’s ability to reject the transplant, but despite this, patients’ immune systems attack the transplant and can cause rejection. This is treated with extra immunosuppressant medication and can cause increased side effects. Some transplant patients reject more than others and it is not fully understood why.
Many essential bacteria live on all of us, and keep us healthy. Research has shown that these bacteria change with illness and medication, and even effect how transplants work. This study will discover how our passenger bacteria impact hand transplants. This will help early diagnosis of rejection in hand transplant patients, so it can be treated with less medicine and fewer side effects.
Patients who have received a hand transplant in the UK will be invited to participate in this observational study. Samples of skin and gut bacteria will be sampled at 2 timepoints to assess for any change in bacteria over time. Repeat sampling will take place triggered by a rejection episode. Samples will also be compared to those taken from healthy volunteers.
This study will be used as a pilot for a larger multicentre study, which aims to analyse results from both patients who have already had a hand transplant and new patients to include both pre and post-transplant timepoints.REC name
East of England - Cambridge South Research Ethics Committee
REC reference
24/EE/0048
Date of REC Opinion
1 Mar 2024
REC opinion
Further Information Favourable Opinion