GEMIT Study
Research type
Research Study
Full title
Crohn’s disease-related polymorphisms in intestinal transplantation
IRAS ID
291900
Contact name
Sofie Vets
Contact email
Sponsor organisation
UZ Leuven
Duration of Study in the UK
0 years, 6 months, 2 days
Research summary
Intestinal transplantation (ITx) is a life-saving procedure for patients with irreversible intestinal failure. These patients have insufficient working intestine to support life and require intravenous nutrition. However, due to the high concentration of immunological cells (such as lymphocytes) and bacteria, ITx has the highest rejection rate and lowest 5-year survival rates (±50%) of any organ transplant. The key cells are the Paneth Cells, which release products to maintain normal bacterial levels inside the gut. Recent research has shown that if these cells dysfunction, this can lead to Crohn’s disease (CD), a severe inflammatory disease in the intestine. Genetic research in patients with CD has demonstrated that there are more than 70 known genetic risk factors; termed CD-related polymorphisms. Early studies in ITx patients show an unusually high rate of CD-related polymorphisms and that those patients have a higher rate of rejection and poorer outcomes.
The aim of this study is to look at 9 known CD-related polymorphisms in adult ITx patients. We will look at the genetic information of both the donor and the recipient. We will then study the outcomes, including rejection rates and survival. This will allow us to: 1/identify genetic variants that increase rejection risks and 2/allow donor organs and recipients to be better matched in the future.
The genetic information will be recovered from donor samples stored at the NHS Blood & Transplant. ITx patients will be asked to submit a blood sample to recover DNA at their treatment centers as they undergo routine follow-up. It will take 6 months to analyze the results. At the end of the study, the individual results will be shared with patients. Eventually this will allow for patient specific anti-rejection therapy that is just high enough to avoid rejection while reducing long-term complications of the medications.REC name
London - Chelsea Research Ethics Committee
REC reference
20/PR/0947
Date of REC Opinion
17 Feb 2021
REC opinion
Further Information Favourable Opinion