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Innovative Approach to Fecal Microbiota Transplantation (FMT) Applied for Chronic Kidney Disease (CKD)

NCT04222153 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2023-02-08

No results posted yet for this study

Summary

The aim of this PhD project focuses on the relationship between intestinal microbiota and health in the background of Chronic Kidney Disease (CKD). Many pathologies, including the CKD, display a dysbiosis of the intestinal microbiota, which is at the same time a consequence of CKD and contributes to its progression and complication. In a variety of chronic-degenerative and infectious diseases, the "fecal microbiota transplantation" (FMT) is being tested in recent years in addition with the application of both probiotics and prebiotics. FMT is indeed currently successfully used in the eradication of recurrent Clostridium difficile infections, with success rates of 90%, thus recent evidence suggests that FMT could be applied in other diseases characterized by microbiota dysbiosis, such as CKD and diabetes, in which the FMT has never been previously tested.

This project will allow to study:

i) the prototypal production of the encapsulated suspension of healthy microbiota tested in a minimally invasive FMT procedure (by oral administration);

ii) the efficacy of the innovative prototype for colonization and modulation of intestinal microbiota following FMT;

iii) the experimental and clinical feedback of this suspension, by in vivo studies.

Conditions

  • Healthy
  • Chronic Kidney Diseases

Sponsors & Collaborators

  • University of Bari Aldo Moro

    collaborator OTHER

  • Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

    lead OTHER

Principal Investigators

  • Loreto Gesualdo, MD Full Prof · Nephrology, Dialysis and Transplantation Unit "Aldo Moro" University of Bari

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-26
Primary Completion
2020-02-26
Completion
2021-12-26

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04222153 on ClinicalTrials.gov