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Completed

NCT Number: NCT03815786

NATURE 3.1_New Approach for the Reduction of REnal Uremic Toxins

The objective of the pilot study is to validate the clinical use of an innovative symbiotic in patients with chronic kidney disease (CKD) stage 3b-4 and in healthy subjects.

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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Key information

Conditions

Chronic Kidney Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Healthy Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AUO Policlinico Consorziale

Bari, BA, 70125, Italy

Who can participate

Healthy volunteers accepted: Yes

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

CKD patients

Inclusion criteria

  • CKD patients stage 3b-4 not on dialysis
  • Aged between 30 to 65
  • BMI between 18.5 and 29.9
  • Controlled diet
  • Informed consent signed

Exclusion criteria

  • 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

Healthy volunteers

Inclusion criteria

  • 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

  • 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

Treatment and study plan

Symbiotic

Dietary Supplement

2-months oral administration of the symbiotic supplement (2 bags/day) + 1 month washout

Placebo

Dietary Supplement

2-months oral administration of the placebo (2 bags/day) + 1 month washout

Primary outcomes

  1. Change of serum concentration of pCS

    Time frame: 3 months

    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: 3 months

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

  2. Change of serum concentration of D-lactate

    Time frame: 3 months

    Change of D-lactate serum concentration (uM)

  3. Change of serum concentration of LPS

    Time frame: 3 months

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

  4. Change of percentage of sugar urinary recovery

    Time frame: 3 months

    Change of percentage (%) of urinary recovery of 4 sugars (lactulose, mannitol, sucrose and sucralose)

  5. Change of serum concentration of inflammatory markers

    Time frame: 3 months

    Change of interleukin (IL)6, IL10, IL17, pentraxin3 (PTX3) serum concentrations (pg/ml) evaluated by ELISA

  6. Change of serum concentration of NO

    Time frame: 3 months

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

Other outcomes

  1. Gut microbiota

    Time frame: 3 months

    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: 3 months

    Change of gastrointestinal symptoms evaluated by Gastrointestinal Symptoms Rating Scale (GSRS) questionnaire (15 items scored 0-3 each, 0 representing the best and 3 the worse outcome for each item)

  3. Change of stool type

    Time frame: 3 months

    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: 3 months

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

Acronym: NATURE31

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 24, 2019
Registry last updated
Feb 15, 2022

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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