Influence of the Intestinal Microbiota on the Clinical Course of Renal Transplantation

NCT04874896 | Unknown

• 1 other identifier: Microbiota TX (010-20)
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Renal Transplant

Outcome Measures

Primary Outcomes (1)

• 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

  6 months after transplantation

Secondary Outcomes (7)

• Occurrence of post-transplant urinary tract infections

  6 months after transplantation

• Evaluate the dose/level ratio of immunosuppressive drugs

  6 months after transplantation

• Evaluate the proportion of acute rejection episodes

  6 months after transplantation

• Determined Treg lymphocyte populations

  6 months after transplantation compared to pre transplant situation

• Systemic inflammation

  6 months after transplantation

Study Arms (2)

Control

ACTIVE COMPARATOR

Patients of this branch will not have autotransplantation of gut microbiota in capsules and will follow their usual post-transplant treatment

Dietary Supplement: Control

Microbiota autotransplantation

ACTIVE COMPARATOR

Patients in this branch will receive autotransplantation of intestinal microbiota in capsules for 6 months post-transplantation

Dietary Supplement: Microbiota autotransplantation

Interventions

Microbiota autotransplantation DIETARY_SUPPLEMENT

Patients received microbiota autotransplantation in capsules (1g per day) for 6 months

Microbiota autotransplantation

Control DIETARY_SUPPLEMENT

Patients will not received microbiota autotransplantation in capsules and will received usual medical care

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 dysphagia, history of aspiration pneumonia or neutropenia prior to transplantation.

Sponsors & Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal: lead

Study Sites (1)

Hospital Ramón y Cajal

Madrid, 28034, Spain

RECRUITING

Central Study Contacts

Esmeralda Castillo Rodríguez, MD

CONTACT

913368018; esmeralda.castle@gmail.com

Andrea Collado Alsina, PhD

CONTACT

913368018; macolladoalsina@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center, randomized, intervention pilot study with a sample size of 50 patients (25 patients in intervention group who will receive gut microbiota autotransplantation and 25 group in control group without intervention) for a follow-up time of 6 months

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: May 6, 2021
• Study Start: December 1, 2020
• Primary Completion: December 1, 2024
• Study Completion: September 1, 2025
• Last Updated: September 13, 2023

Record last verified: 2023-05

Locations

ES (1)