NATURE 3.1_New Approach for the Reduction of REnal Uremic Toxins (NATURE31)

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Status: Completed

Conditions: Chronic Kidney Diseases; Healthy

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Symbiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT03815786

XUANRO4-NATURE 3.1

Details and patient eligibility

About

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

Enrollment: 50 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

CKD patients

Inclusion Criteria:

• CKD patients stage 3b-4 not on dialysis
• Aged between 30 to 65
• BMI between 18.5 and 29.9
• Controlled diet
• Informed consent signed

Exclusion Criteria:

• Type 2 diabetes mellitus
• Use of antibiotics or probiotics up to 30 days prior to recruitment
• Chronic gastrointestinal disorders
• Systemic inflammatory diseases
• Suspicion or clinical diagnosis of malignancy
• Chronic liver disease
• Treatment with corticosteroids or immunosuppressive drugs
• Previous acute cardiovascular diseases (myocardial infarction, stroke)
• Psychiatric conditions reducing the compliance to treatment protocols

Healthy volunteers

Inclusion Criteria:

• Healthy subjects
• Aged between 35 to 60
• BMI between 18.5 and 29.9
• Medium score of adherence to Mediterranean Diet (PREDIMED score between 6 and 9)
• Informed consent signed

Exclusion Criteria:

• Type 2 diabetes mellitus
• Use of antibiotics or probiotics up to 30 days prior to recruitment
• Chronic gastrointestinal disorders
• Systemic inflammatory diseases
• Suspicion or clinical diagnosis of malignancy
• Chronic liver disease
• Treatment with corticosteroids or immunosuppressive drugs
• Previous acute cardiovascular diseases (myocardial infarction, stroke)
• Psychiatric conditions reducing the compliance to treatment protocols

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

CKD patients

Experimental group

Description:

CKD patients stage 3b-4 will follow a 2-months supplementation of either symbiotic or placebo

Treatment:

Dietary Supplement: Symbiotic

Dietary Supplement: Placebo

Controls

Other group

Description:

Healthy volunteers will follow a 2-months supplementation of either symbiotic or placebo

Treatment:

Dietary Supplement: Symbiotic

Dietary Supplement: Placebo