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NATURE 3.2_New Approach for the Reduction of REnal Uremic Toxins

NCT03946176 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2019-05-10

No results posted yet for this study

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

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

Sponsors & Collaborators

  • University of Bari Aldo Moro

    collaborator OTHER

  • Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

    lead OTHER

Principal Investigators

  • Loreto Gesualdo, MD Full Prof · Nephrology, Dialysis and Transplantation Unit "Aldo Moro" University of Bari

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-17
Primary Completion
2017-10-27
Completion
2017-10-27

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03946176 on ClinicalTrials.gov