NATURE 3.2_New Approach for the Reduction of REnal Uremic Toxins
NCT ID: NCT03946176
Last Updated: 2019-05-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
16 participants
INTERVENTIONAL
2017-05-17
2017-10-27
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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Symbiotic
HD patients with 7 weeks symbiotic administration + 1 week overlapping with the 3 dialytic sessions with the DVB cartridge
Symbiotic
HD patients follow a 8-weeks oral administration of the symbiotic supplement (2 bags/day)
DVB cartridge
On the last week of the symbiotic/placebo period, patients undergo 3 dialytic sessions with the DVB cartridge
Placebo
HD patients with 7 weeks placebo administration + 1 week overlapping with the 3 dialytic sessions with the DVB cartridge
Placebo
HD patients follow a 8-weeks oral administration of the placebo (2 bags/day)
DVB cartridge
On the last week of the symbiotic/placebo period, patients undergo 3 dialytic sessions with the DVB cartridge
Interventions
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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)
DVB cartridge
On the last week of the symbiotic/placebo period, patients undergo 3 dialytic sessions with the DVB cartridge
Eligibility Criteria
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Inclusion Criteria
* Aged between 30 to 65
* BMI between 18.5 and 29.9
* Omnivore diet
* Informed consent signed
Exclusion Criteria
* 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
30 Years
65 Years
ALL
No
Sponsors
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University of Bari Aldo Moro
OTHER
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
OTHER
Responsible Party
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Principal Investigators
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Loreto Gesualdo, MD Full Prof
Role: PRINCIPAL_INVESTIGATOR
Nephrology, Dialysis and Transplantation Unit "Aldo Moro" University of Bari
Locations
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AOUConsorziale Policlinico Di Bari
Bari, , Italy
Countries
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Other Identifiers
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XUANRO4-NATURE 3.2
Identifier Type: -
Identifier Source: org_study_id
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