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NATURE 3.1_New Approach for the Reduction of REnal Uremic Toxins

NCT03815786 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-02-15

No results posted yet for this study

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

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

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
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-24
Primary Completion
2017-10-17
Completion
2017-10-17

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 NCT03815786 on ClinicalTrials.gov