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Completed

NCT Number: NCT03946176

NATURE 3.2_New Approach for the Reduction of REnal Uremic Toxins

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

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Key information

Conditions

Hemodialysis

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AOUConsorziale Policlinico Di Bari

Bari, 70124, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Symbiotic

Dietary Supplement

HD patients follow a 8-weeks oral administration of the symbiotic supplement (2 bags/day)

Placebo

Dietary Supplement

HD patients follow a 8-weeks oral administration of the placebo (2 bags/day)

DVB cartridge

Device

On the last week of the symbiotic/placebo period, patients undergo 3 dialytic sessions with the DVB cartridge

Primary outcomes

  1. Change of serum concentration of pCS

    Time frame: 8 weeks

    Change of p-cresyl sulfate (pCS) serum concentrations assessed by liquid chromatography/mass spectrometry

Secondary outcomes

  1. Change of serum concentration of IS

    Time frame: 8 weeks

    Change of indoxyl sulfate (IS) serum concentrations assessed by liquid chromatography/mass spectrometry

  2. Change of serum concentration of D-lactate

    Time frame: 8 weeks

    Change of D-lactate serum concentration (uM)

  3. Change of serum concentration of LPS

    Time frame: 8 weeks

    Change of lipopolysaccharide (LPS) serum concentration (EU/ml)

  4. Change of serum concentration of inflammatory markers

    Time frame: 8 weeks

    Change of interleukin (IL)IL10, IL17, pentraxin3 (PTX3) serum concentrations (pg/ml) evaluated by ELISA

  5. Change of serum concentration of NO

    Time frame: 8 weeks

    Change of nitric oxide (NO) serum concentration (uM) evaluated by spectrometry

Other outcomes

  1. Gut microbiota

    Time frame: 8 weeks

    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.

  2. Change of GI symptoms

    Time frame: 8 weeks

    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)

  3. Change of stool type

    Time frame: 8 weeks

    Change of stool type evaluated by BRISTOL Stool Scale (range 1-7, lower and higher values representing worse outcome, middle values representing better outcome)

  4. Change of serum concentration of TMAO

    Time frame: 8 weeks

    Change of trimethylamine-N-oxide (TMAO) serum concentrations assessed by liquid chromatography/mass spectrometry

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Other

Collaborators

  • University of Bari Aldo Moro

Registry information

Official study title

XUANRO4 - NATURE 3.2 - Nuovo Approccio Per la Riduzione Delle Tossine Uremiche Renali, REGIONE PUGLIA - FSC 2007-2013 Ricerca. Intervento "Cluster Tecnologici Regionali"

Acronym: NATURE32

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 10, 2019
Registry last updated
May 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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