An observational study in Healthy and Chronic Kidney Diseases, sponsored by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari. Completed at 1 site in Italy. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-08.
Sponsored by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari · Observational
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.
This project will allow to experiment the Fecal microbiota transplantation in the CKD model and to set up a pharmaceutical formulation of fecal suspensions of microbiota.
Firstly, a collection of fecal samples from healthy volunteers will be set up, with the aim to collect biological samples. Screening and enrollment of healthy volunteers, gathering personal and clinical information together with eating habits, will be performed.
The best product design in efficacy, stability over time as well as suitable excipients and any other active components able to perform a synergistic action will be evaluated. After defining the pharmaceutical formulation, the production of the prototype will be finalized.
In a second time in vivo studies on a model of CKD (uremic mouse with CKD induced by 5/6 nephrectomy) will be designed and carried on. The CKD model will be used to evaluate the effects and the outcomes of FMT on clinical parameters such as renal function, circulating levels of uremic toxins, state and function of the intestinal microbiota, intestinal permeability and microbiota composition. This step will be necessary to establish the efficacy of the innovative prototype for the colonization and the modulation of intestinal microbiota following FMT.
3,224 studies on the registry are indexed under Renal Insufficiency, Chronic; 706 are open to participants now.
This study's enrollment of 10 is below the median of 200 across 889 observational studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari is the lead sponsor of 47 studies on the registry; 11 are open to participants now.
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The study population is composed by healthy volunteers, aged between 18 and 50, with normal BMI and characterized by omnivorous diet.
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Criteria: Healthy volunteers
Inclusion Criteria:
Exclusion Criteria:
Number of healthy volunteers enrolled according to the procedures of the FMT01 protocol
A final number of 10 healthy volunteers will be selected to collect their fecal samples, according to the protocol FMT01 (ref. Cammarota G et al. Gut 2017 doi:10.1136/gutjnl-2016-313017): 1. Preliminary interview - anamnestic interview to exclude people with history of disease and risk factors 2. Secondary interview - anamnestic interview (on the day of donation) to exclude donors with recently appeared harmful issues 3. Sample collection - blood and stool testing to verify the presence of potentially transmittable disease: Cytomegalovirus, Epstein-Barr virus, Hepatitis A, HBV, HCV, Syphilis, HIV-1 and HIV-2, Faecal Helicobacter pylori, Faecal occult blood testing, Fecal ova and parasites Steps 1 and 2 will be analyzed by the physician in order to exclude people, after enrollment, at risk of potential harmful issues. People passing steps 1 and 2 will undergo blood and fecal laboratory screening. Positivity to one or more of the tested factor will result in volunteer exclusion.
Time frame: 2 months
Plan to share: Undecided
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This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Renal Insufficiency, Chronic →
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari