Institut de Recerca Hospital Vall d´Hebron
Barcelona, 08035, Spain
NCT Number: NCT02223468
The microbiota represents the collections of microbial communities that colonize a host. In health, the microbiota protects against pathogens and maturation of the immune system. In return, the immune system determines the composition of the microbiota. Altered microbial composition (dysbiosis) has been correlated with a number of diseases in humans. The real role of the microbiota in transplant recipients is still unknown even though we suspect that it may be affected directly or indirectly by immunosuppressive drugs and antimicrobial prophylaxis taken by transplant patients, as well as by inflammatory process secondary to ischemia/reperfusion injury.
A number of studies have investigated the impact of liver transplantation on the intestinal microbiota. In a recent analysis of stool flora (Microb Ecol 2013; 65: 781-791) in 12 liver transplant recipients, changes in the microbiota were correlated to post-transplant infections. The authors suggested that the shift to pathogenic strains of bacteria due to the use of prophylactic antibiotics may be contributing to post-transplant complications. In a larger study, Wu et al (Hepatobiliary Pancreat Dis Int 2012; 11: 40-50) demonstrated marked changes in the gut microbiota post-transplantation with an increase in Enterobacteriaceae and Enterococcus, and reduction in Eubacteria, Bifidobacterium and Lactobacillus species. These changes, however, resolved over time such that by 6 months, at times when bacterial prophylaxis ends and immunosuppression is reduced.
A better characterization of the impact of post-transplant therapy on the human microbiota has the potential to improve our understanding of the infection process and translate into development of new therapeutic strategies.
The main goal of this study is to characterize intestinal microbiota and confirm the same bacterial DNA in peripheral blood and portal lymph nodes in patients affected with end-stage chronic liver disease, and to analyze its evolution from the moment of inclusion in waiting list throughout the first year after liver transplantation. For each patient, a healthy CONTROL with a similar age (± 10 years) will be selected from the same family setting, in whom just one sample will be obtained during the enrollment phase.
The second goal is to analyze the potential associations between microbiota flora and transplant outcomes during the same period.
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Notify Me18 year–68 year
All sexes
Observational
Barcelona, 08035, Spain
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Before transplant, 1st, 3rd, 7th, 14th and 28th post-transplant and 3rd, 6th, 9th and 12th months post-transplant
Stool samples will be obtained from the liver transplant recipient following the time frame described above.
A healthy CONTROL with a similar age (± 10 years) will be selected from the same family setting, in whom just one sample will be obtained during the enrollment phase
Time frame: Evaluation at 3rd, 6th, 9th and 12th months post-trasplant
If liver dysfunction is observed, percutaneous liver biopsy will be performed and histological severity will be searching following the Banff criteria
Time frame: Evaluation at 3rd, 6th, 9th and 12th months post-trasplant
Time frame: 12 months post-trasplant
Time frame: 12 months post-transplant
Time frame: Evaluation at 3rd, 6th, 9th and 12th months post-trasplant
Time frame: Evaluation at 3rd, 6th, 9th and 12th months post-trasplant
Hospital Vall d'Hebron
Other
Prospective Study To Characterize The Human Microbiota In Liver Transplantation And Its Impact On Early Outcome
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