NCT03815786

NATURE 3.1_New Approach for the Reduction of REnal Uremic Toxins

XUANRO4 - NATURE 3.1 - Nuovo Approccio Per la Riduzione Delle Tossine Uremiche Renali, REGIONE PUGLIA FSC 2007-2013 Ricerca. Intervento Cluster Tecnologici Regionali

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari · Academic / Other
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The objective of the pilot study is to validate the clinical use of an innovative symbiotic in patients with chronic kidney disease (CKD) stage 3b-4 and in healthy subjects. The study aims at evaluating the effects of a symbiotic, consisting of a mixture of probiotics (Lactobacilli and Bifidobacteria), prebiotics (fructooligosaccharides and inulin) and natural antioxidants (a mix of quercetin, resveratrol and proanthocyanidins), by achieving two objectives: 1. Reduction of the serum levels of microbiota-derived uremic toxins, involved in a variety of cardiovascular complications in CKD 2. Reduction of intestinal permeability, inflammatory markers and oxidative stress

Conditions

• Chronic Kidney Diseases
• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Symbiotic	2-months oral administration of the symbiotic supplement (2 bags/day) + 1 month washout
DIETARY_SUPPLEMENT	Placebo	2-months oral administration of the placebo (2 bags/day) + 1 month washout

Timeline

• Start date: 2017-05-24
• Primary completion: 2017-10-17
• Completion: 2017-10-17
• First posted: 2019-01-24
• Last updated: 2022-02-15

Locations

1 site across 1 country: Italy