Clinical trial NCT03815786: NATURE 3.1_New Approach for the Reduction of REnal Uremic Toxins
Official title: XUANRO4 - NATURE 3.1 - Nuovo Approccio Per la Riduzione Delle Tossine Uremiche Renali, REGIONE PUGLIA FSC 2007-2013 Ricerca. Intervento Cluster Tecnologici Regionali
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Diseases
Healthy
Keywords: gut microbiota dysbiosis
uremic toxins
symbiotic
Lead sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Sponsor class: OTHER
Collaborators: name: University of Bari Aldo Moro
First posted: 2019-01-24
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility 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

Primary outcomes:
measure: Change of serum concentration of pCS
timeFrame: 3 months
Secondary outcomes:
measure: Change of serum concentration of IS
timeFrame: 3 months
measure: Change of serum concentration of D-lactate
timeFrame: 3 months
measure: Change of serum concentration of LPS
timeFrame: 3 months
measure: Change of percentage of sugar urinary recovery
timeFrame: 3 months
measure: Change of serum concentration of inflammatory markers
timeFrame: 3 months
measure: Change of serum concentration of NO
timeFrame: 3 months
Other outcomes:
measure: Gut microbiota
timeFrame: 3 months
measure: Change of GI symptoms
timeFrame: 3 months
measure: Change of stool type
timeFrame: 3 months
measure: Change of serum concentration of TMAO
timeFrame: 3 months
Locations:
city: Bari
country: Italy
facility: AUO Policlinico Consorziale
state: BA
Study officials:
affiliation: Nephrology, Dialysis and Transplantation Unit "Aldo Moro" University of Bari
name: Loreto Gesualdo, MD Full Prof
role: PRINCIPAL_INVESTIGATOR
References: