An interventional study of Microbiota autotransplantation and Control in Renal Transplant, sponsored by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-13.
Sponsored by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · Not applicable, Interventional, and Prevention
ACKGROUND: The development of new molecular techniques, in recent years, has increasing the knowledge of the composition and functionality of the intestinal microbiota. In the area of kidney transplantation, observational studies have described a change in the intestinal microbiota during the immediate post-transplantation period that seems to be related to the appearance of clinical outcomes such as diarrhea, repeated urinary tract infections, the need for adjustment of immunosuppressive treatment or acute rejection. However, intervention studies on this subject are necessary to determine how far the microbiota can influence in the development of these events.
OBJECTIVE: To clarify the influence of maintaining the composition and functionality of the intestinal microbiota on post-transplant clinical outcomes such as diarrhea, urinary tract infections, kidney graft rejection and the need for dose adjustment of immunosuppressive therapy.
MATERIALS AND METHODS: single-center, randomized, interventional pilot study with 50 deceased kidney donor transplant patients at low immunological risk. Each patient will be randomized at the time of inclusion in the study to one of the 2 branches of the study: 1) Intervention group: 25 patients who will receive a autologous fecal matter transfer during the first 6 months post-transplantation, 2) Control group: 25 renal transplant patients with the same characteristics who will not receive any type of intervention in addition to the immunosuppressive treatment indicated according to hospital protocol.
ACKGROUND: The development of new molecular techniques, in recent years, has increasing the knowledge of the composition and functionality of the intestinal microbiota. In the area of kidney transplantation, observational studies have described a change in the intestinal microbiota during the immediate post-transplantation period that seems to be related to the appearance of clinical outcomes such as diarrhea, repeated urinary tract infections, the need for adjustment of immunosuppressive treatment or acute rejection. However, intervention studies on this subject are necessary to determine how far the microbiota can influence in the development of these events.
OBJECTIVE: To clarify the influence of maintaining the composition and functionality of the intestinal microbiota on post-transplant clinical outcomes such as diarrhea, urinary tract infections, kidney graft rejection and the need for dose adjustment of immunosuppressive therapy.
MATERIALS AND METHODS: single-center, randomized, interventional pilot study with 50 deceased kidney donor transplant patients at low immunological risk. Each patient will be randomized at the time of inclusion in the study to one of the 2 branches of the study: 1) Intervention group: 25 patients who will receive a autologous fecal matter transfer during the first 6 months post-transplantation, 2) Control group: 25 renal transplant patients with the same characteristics who will not receive any type of intervention in addition to the immunosuppressive treatment indicated according to hospital protocol.
544 studies on the registry are indexed under Disease Progression; 144 are open to participants now.
This study's planned enrollment of 50 is below the median of 87 across 266 interventional studies indexed under Disease Progression.
Browse Disease Progression studies →Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal is the lead sponsor of 82 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients of this branch will not have autotransplantation of gut microbiota in capsules and will follow their usual post-transplant treatment
Dietary Supplement: Control
Patients in this branch will receive autotransplantation of intestinal microbiota in capsules for 6 months post-transplantation
Dietary Supplement: Microbiota autotransplantation
Patients received microbiota autotransplantation in capsules (1g per day) for 6 months
Patients will not received microbiota autotransplantation in capsules and will received usual medical care
Evaluate the occurrence of diarrhea
Evaluate the occurrence of diarrhea regardless of its cause, between the intervention and control groups. Diarrhea will be defined as three or more bowel movements per day (or more frequently than normal for the individual), and presence of loose or liquid stools, following WHO definition
Time frame: 6 months after transplantation
Occurrence of post-transplant urinary tract infections
Evaluate the occurrence of post-transplant urinary tract infections (UTI), defined as positive urine culture with associated voiding symptoms or fever, as well as positive urine cultures until removal of the double J catheter, given that they will receive antibiotic treatment as if it were a UTI. Positive urine cultures or asymptomatic bacteriuria after removal of the double J catheter (usually at one-month post-transplantation) will not be included in the definition.
Time frame: 6 months after transplantation
Evaluate the dose/level ratio of immunosuppressive drugs
Evaluate the dose/level ratio of immunosuppressive drugs (tacrolimus or everolimus) administered in the intervention groups with respect to the control group
Time frame: 6 months after transplantation
Evaluate the proportion of acute rejection episodes
Evaluate the proportion of acute rejection episodes between the two groups in the follow-up period
Time frame: 6 months after transplantation
Determined Treg lymphocyte populations
Evaluate whether there are differences between the Treg lymphocyte populations in peripheral blood by flow cytometry between the two groups
Time frame: 6 months after transplantation compared to pre transplant situation
Systemic inflammation
Measurement of inflammatory markers in serum by automated systems, such as C-reactive protein
Time frame: 6 months after transplantation
Production of bacterial metabolites
Determination of the short-chain fatty acids (SCFA) concentration as bacterial metabolites in feces and urine by LC-MS/MS as indicators of the functionality of the microbiota
Time frame: 6 months after transplantation compared to pre transplant situation
Analysis of the bacteria composing the microbiota
Analysis of the bacteria composing the microbiota by massive sequencing of the 16S rDNA gene
Time frame: 6 months after transplantation compared to pre transplant situation
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Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal