Completed

Fecal Microbiota Transplantation for Chronic Kidney Disease: Formulation and In Vivo Studies

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Study Aim

This observational study aims to enroll healthy volunteers, following the FMT01 protocol, to collect fecal samples for Fecal Microbiota Transplantation in Chronic Kidney Disease, ensuring the donors are free from potentially transmittable diseases.

What is being collected

Data Collection

Collected at a single point in time - Cross-sectional
Who is being recruted

Urogenital Diseases+9

+ Chronic Disease

+ Female Urogenital Diseases and Pregnancy Complications

From 18 to 50 Years
+24 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other

Utilizing specific methods not covered by standard models in order to address unique research questions.
Observational
Study Start: November 2019
See protocol details

Summary

Principal SponsorAzienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 26, 2019

Actual date on which the first participant was enrolled.

This study is about trying a new approach to fecal microbiota transplantation for chronic kidney disease (CKD). The main goal is to create a pharmaceutical formulation of fecal suspensions from healthy volunteers. This is important because it could potentially improve the treatment of CKD by modulating the intestinal microbiota, which may affect renal function and levels of uremic toxins. The study focuses on healthy volunteers who will donate their fecal samples for this purpose. The study begins with collecting fecal samples from healthy volunteers, after they have been screened and enrolled. The screening process involves two interviews and laboratory tests to ensure the donors are healthy and free from potentially transmittable diseases. Once the best product design is determined, a prototype will be produced. This prototype will then be tested on a CKD mouse model to evaluate its effects on renal function, uremic toxin levels, intestinal microbiota, and microbiota composition. The study aims to enroll 10 healthy volunteers according to the FMT01 protocol. The volunteers will be selected carefully to avoid any potential risks.

Official TitleApproccio Innovativo di Trapianto di Microbiota Fecale Applicato Alla Malattia Renale Cronica
Principal SponsorAzienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other

Some studies use unique or mixed approaches that don't fit standard categories. These may include innovative observational methods or studies tailored to specific research questions.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 50 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesChronic DiseaseFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsUrologic DiseasesDisease AttributesRenal Insufficiency, ChronicRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

24 exclusion criteria prevent from participating
Health workers (to exclude the risk of transmission of multi-resistant organisms)

Type 2 diabetes mellitus

Hypertension

Chronic liver disease

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

AUO Policlinico Consorziale

Bari, ItalyOpen AUO Policlinico Consorziale in Google Maps
CompletedOne Study Center