Clinical trial NCT03946176: NATURE 3.2_New Approach for the Reduction of REnal Uremic Toxins
Official title: XUANRO4 - NATURE 3.2 - 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: Hemodialysis
Keywords: uremic toxins
gut microbiota dysbiosis
symbiotic
divinylbenzene cartridge
Lead sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Sponsor class: OTHER
Collaborators: name: University of Bari Aldo Moro
First posted: 2019-05-10
Enrollment: 16
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: Inclusion Criteria:

* CKD patients on bicarbonate hemodialysis
* Aged between 30 to 65
* BMI between 18.5 and 29.9
* Omnivore diet
* Informed consent signed

Exclusion Criteria:

* 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
* Psychiatric conditions reducing the compliance to treatment protocols

Primary outcomes:
measure: Change of serum concentration of pCS
timeFrame: 8 weeks
Secondary outcomes:
measure: Change of serum concentration of IS
timeFrame: 8 weeks
measure: Change of serum concentration of D-lactate
timeFrame: 8 weeks
measure: Change of serum concentration of LPS
timeFrame: 8 weeks
measure: Change of serum concentration of inflammatory markers
timeFrame: 8 weeks
measure: Change of serum concentration of NO
timeFrame: 8 weeks
Other outcomes:
measure: Gut microbiota
timeFrame: 8 weeks
measure: Change of GI symptoms
timeFrame: 8 weeks
measure: Change of stool type
timeFrame: 8 weeks
measure: Change of serum concentration of TMAO
timeFrame: 8 weeks
Locations:
city: Bari
country: Italy
facility: AOUConsorziale Policlinico Di Bari
Study officials:
affiliation: Nephrology, Dialysis and Transplantation Unit "Aldo Moro" University of Bari
name: Loreto Gesualdo, MD Full Prof
role: PRINCIPAL_INVESTIGATOR
References: