Fecal Microbiota Transplantation for Chronic Kidney Disease: Formulation and In Vivo Studies
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.
Data Collection
Collected at a single point in time - Cross-sectionalUrogenital Diseases+9
+ Chronic Disease
+ Female Urogenital Diseases and Pregnancy Complications
Other
Utilizing specific methods not covered by standard models in order to address unique research questions.Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.10 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.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