NCT03946176

NATURE 3.2_New Approach for the Reduction of REnal Uremic Toxins

XUANRO4 - NATURE 3.2 - 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: 16 (actual)
• Sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari · Academic / Other
• Sex: All
• Age: 30 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The objective of the pilot study is to validate a combined approach based on the use of an innovative symbiotic and an innovative dialysis cartridge in patients on hemodialysis (HD). The symbiotic consists of a mixture of probiotics (Lactobacilli and Bifidobacteria), prebiotics (fructoligosaccharides and inulin) and natural antioxidants (a mix of quercetin, resveratrol and proanthocyanidins). The cartridge is composed of a divinylbenzene (DVB) adsorbing resine, expected to have high affinity to protein-bound uremic toxins pCS and IS, on the basis of its chemical structure. This combined approach will be aimed at achieving two main objectives: 1. reduction of blood levels of microbial-derived uremic toxins, involved in cardiovascular complications 2. reduction of inflammation markers and oxidative stress and reduction of intestinal permeability

Conditions

• Hemodialysis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Symbiotic	HD patients follow a 8-weeks oral administration of the symbiotic supplement (2 bags/day)
DIETARY_SUPPLEMENT	Placebo	HD patients follow a 8-weeks oral administration of the placebo (2 bags/day)
DEVICE	DVB cartridge	On the last week of the symbiotic/placebo period, patients undergo 3 dialytic sessions with the DVB cartridge

Timeline

• Start date: 2017-05-17
• Primary completion: 2017-10-27
• Completion: 2017-10-27
• First posted: 2019-05-10
• Last updated: 2019-05-10

Locations

1 site across 1 country: Italy