NATURE 3.1_New Approach for the Reduction of REnal Uremic Toxins
NCT ID: NCT03815786
Last Updated: 2022-02-15
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
50 participants
INTERVENTIONAL
2017-05-24
2017-10-17
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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CKD patients
CKD patients stage 3b-4 will follow a 2-months supplementation of either symbiotic or placebo
Symbiotic
2-months oral administration of the symbiotic supplement (2 bags/day) + 1 month washout
Placebo
2-months oral administration of the placebo (2 bags/day) + 1 month washout
Controls
Healthy volunteers will follow a 2-months supplementation of either symbiotic or placebo
Symbiotic
2-months oral administration of the symbiotic supplement (2 bags/day) + 1 month washout
Placebo
2-months oral administration of the placebo (2 bags/day) + 1 month washout
Interventions
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Symbiotic
2-months oral administration of the symbiotic supplement (2 bags/day) + 1 month washout
Placebo
2-months oral administration of the placebo (2 bags/day) + 1 month washout
Eligibility Criteria
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Inclusion Criteria
* Aged between 30 to 65
* BMI between 18.5 and 29.9
* Controlled diet
* Informed consent signed
* 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
* 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
* 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
30 Years
65 Years
ALL
Yes
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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AUO Policlinico Consorziale
Bari, BA, Italy
Countries
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References
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Vacca M, Celano G, Calabrese FM, Rocchetti MT, Iacobellis I, Serale N, Calasso M, Gesualdo L, De Angelis M. In vivo evaluation of an innovative synbiotics on stage IIIb-IV chronic kidney disease patients. Front Nutr. 2023 Jun 15;10:1215836. doi: 10.3389/fnut.2023.1215836. eCollection 2023.
Other Identifiers
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XUANRO4-NATURE 3.1
Identifier Type: -
Identifier Source: org_study_id
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