NATURE 3.1_New Approach for the Reduction of REnal Uremic Toxins

Healthy Clinical Trial

— NATURE31  

Official title:

XUANRO4 - NATURE 3.1 - 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: NCT03815786
• Other study ID #: XUANRO4-NATURE 3.1
• Status: Completed
• Phase: N/A
• Start date: May 24, 2017
• Est. completion date: October 17, 2017

Study information

• Verified date: November 2018
• Source: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 17, 2017
• Est. primary completion date: October 17, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Healthy
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Dietary Supplement:
• 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

Locations

Country	Name	City	State
Italy	AUO Policlinico Consorziale	Bari	BA

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari	University of 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.	3 months
Other	Change of GI symptoms	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 months
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)	3 months
Other	Change of serum concentration of TMAO	Change of trimethylamine-N-oxide (TMAO) serum concentrations assessed by liquid chromatography/mass spectrometry	3 months
Primary	Change of serum concentration of pCS	Change of p-cresyl sulfate (pCS) serum concentrations assessed by liquid chromatography/mass spectrometry	3 months
Secondary	Change of serum concentration of IS	Change of indoxyl sulfate (IS) serum concentrations assessed by liquid chromatography/mass spectrometry	3 months
Secondary	Change of serum concentration of D-lactate	Change of D-lactate serum concentration (uM)	3 months
Secondary	Change of serum concentration of LPS	Change of lipopolysaccharide (LPS) serum concentration (EU/ml)	3 months
Secondary	Change of percentage of sugar urinary recovery	Change of percentage (%) of urinary recovery of 4 sugars (lactulose, mannitol, sucrose and sucralose)	3 months
Secondary	Change of serum concentration of inflammatory markers	Change of interleukin (IL)6, IL10, IL17, pentraxin3 (PTX3) serum concentrations (pg/ml) evaluated by ELISA	3 months
Secondary	Change of serum concentration of NO	Change of nitric oxide (NO) serum concentration (uM) evaluated by spectrometry	3 months