Impact of gut bacteria on kidney transplant outcomes
Influence of the Intestinal Microbiota on the Clinical Course of Renal Transplantation
NA · Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · NCT04874896
This study is testing if improving gut bacteria through a special treatment can help kidney transplant patients have fewer complications and recover better.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal (other) |
| Drugs / interventions | basiliximab |
| Locations | 1 site (Madrid) |
| Trial ID | NCT04874896 on ClinicalTrials.gov |
What this trial studies
This study investigates how the composition and functionality of intestinal microbiota affect clinical outcomes in patients undergoing kidney transplantation. It is a single-center, randomized pilot study involving 50 patients who will be divided into two groups: one receiving autologous fecal matter transfer and the other receiving standard care without intervention. The aim is to determine if maintaining a healthy microbiota can reduce complications such as diarrhea, urinary tract infections, and kidney graft rejection. The study will provide insights into the potential role of gut health in post-transplant recovery.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old receiving a deceased donor kidney transplant with low immunological risk.
Not a fit: Patients with high immunological risk or those with a history of significant intestinal pathology may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of kidney transplant patients by minimizing complications and enhancing graft survival.
How similar studies have performed: While observational studies have indicated a link between microbiota changes and post-transplant outcomes, this interventional approach is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Recipients of deceased donor kidney transplantation over 18 years of age, able to understand the informed consent form and who have agreed to participate in the study. Only patients with low immunological risk, whose induction for kidney transplantation was performed with basiliximab will be included, regardless of the maintenance immunosuppression combination Exclusion Criteria: * Recipients of deceased donor kidney transplant with high immunological risk (within the PATHI kidney transplant program). * Kidney transplant recipients receiving pretransplant induction with thymoglobulin or polyclonal lymphocyte antiglobulin agents. * Living donor kidney transplant recipients. * Patients with a history of intestinal pathology such as: ulcerative colitis, Crohn's disease or malabsorptive syndrome or irritable colon prior to their inclusion in the kidney transplant waiting list. * Patients with dysphagia, history of aspiration pneumonia or neutropenia prior to transplantation. * Patients who, even if they meet the inclusion criteria, upon analysis of pretransplant stool, are found to be carriers of enterotoxigenic or potentially pathogenic strains such as Clostridioides difficile, or multiresistant bacteria (BLEE and/or carbapenemase-producing).
Where this trial is running
Madrid
- Hospital Ramón y Cajal — Madrid, Spain (RECRUITING)
Study contacts
- Study coordinator: Esmeralda Castillo Rodríguez, MD
- Email: esmeralda.castle@gmail.com
- Phone: 913368018
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Renal Transplant