NATURE 3.2_New Approach for the Reduction of REnal Uremic Toxins

Hemodialysis Clinical Trial

— NATURE32  

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"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03946176
• Other study ID #: XUANRO4-NATURE 3.2
• Status: Completed
• Phase: N/A
• Start date: May 17, 2017
• Est. completion date: October 27, 2017

Study information

• Verified date: January 2019
• Source: Azienda Ospedaliero-Universitaria Consorziale
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: October 27, 2017
• Est. primary completion date: October 27, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemodialysis

Intervention

Dietary Supplement:
• Symbiotic
HD patients follow a 8-weeks oral administration of the symbiotic supplement (2 bags/day)
• 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

Locations

Country	Name	City	State
Italy	AOUConsorziale Policlinico Di Bari	Bari

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria Consorziale	Università degli Studi di Bari Aldo Moro

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gut microbiota	Change of the relative abundance (%) of Operational Taxonomic Units (OTUs) of Firmicutes, Bacteroidetes,Proteobacteria, Verrucomicrobia, Actinobacteria, Synergistetes, Cyanobacteria, Euryarchaeota, Chloroflexi, Nitrospirae, Tenericutes, Fusobacteria, Thermotogae, Acidobacteria evaluated by fecal bacterial DNA genome sequencing.	8 weeks
Other	Change of GI symptoms	Change of gastrointestinal symptoms evaluated by Gastrointestinal Symptoms Rating Scale (GSRS) questionnaire (15 items scored 1-7 each, 1 representing the best and 7 the worse outcome for each item)	8 weeks
Other	Change of stool type	Change of stool type evaluated by BRISTOL Stool Scale (range 1-7, lower and higher values representing worse outcome, middle values representing better outcome)	8 weeks
Other	Change of serum concentration of TMAO	Change of trimethylamine-N-oxide (TMAO) serum concentrations assessed by liquid chromatography/mass spectrometry	8 weeks
Primary	Change of serum concentration of pCS	Change of p-cresyl sulfate (pCS) serum concentrations assessed by liquid chromatography/mass spectrometry	8 weeks
Secondary	Change of serum concentration of IS	Change of indoxyl sulfate (IS) serum concentrations assessed by liquid chromatography/mass spectrometry	8 weeks
Secondary	Change of serum concentration of D-lactate	Change of D-lactate serum concentration (uM)	8 weeks
Secondary	Change of serum concentration of LPS	Change of lipopolysaccharide (LPS) serum concentration (EU/ml)	8 weeks
Secondary	Change of serum concentration of inflammatory markers	Change of interleukin (IL)IL10, IL17, pentraxin3 (PTX3) serum concentrations (pg/ml) evaluated by ELISA	8 weeks
Secondary	Change of serum concentration of NO	Change of nitric oxide (NO) serum concentration (uM) evaluated by spectrometry	8 weeks