NCT03815786

Brief 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. 1.Reduction of the serum levels of microbiota-derived uremic toxins, involved in a variety of cardiovascular complications in CKD
  2. 2.Reduction of intestinal permeability, inflammatory markers and oxidative stress

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 24, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 23, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 24, 2019

Completed
Last Updated

February 15, 2022

Status Verified

November 1, 2018

Enrollment Period

5 months

First QC Date

November 23, 2018

Last Update Submit

February 1, 2022

Conditions

Chronic Kidney DiseasesHealthy

Keywords

gut microbiota dysbiosisuremic toxinssymbiotic

Outcome Measures

Primary Outcomes (1)

  • Change of serum concentration of pCS

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

    3 months

Secondary Outcomes (6)

  • Change of serum concentration of IS

    3 months

  • Change of serum concentration of D-lactate

    3 months

  • Change of serum concentration of LPS

    3 months

  • Change of percentage of sugar urinary recovery

    3 months

  • Change of serum concentration of inflammatory markers

    3 months

  • +1 more secondary outcomes

Other Outcomes (4)

  • Gut microbiota

    3 months

  • Change of GI symptoms

    3 months

  • Change of stool type

    3 months

  • +1 more other outcomes

Study Arms (2)

CKD patients

EXPERIMENTAL

CKD patients stage 3b-4 will follow a 2-months supplementation of either symbiotic or placebo

Dietary Supplement: SymbioticDietary Supplement: Placebo

Controls

OTHER

Healthy volunteers will follow a 2-months supplementation of either symbiotic or placebo

Dietary Supplement: SymbioticDietary Supplement: Placebo

Interventions

SymbioticDIETARY_SUPPLEMENT

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

CKD patientsControls
PlaceboDIETARY_SUPPLEMENT

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

CKD patientsControls

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AUO Policlinico Consorziale

Bari, BA, 70125, Italy

Location

Related Publications (1)

  • 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.

    PMID: 37396126DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Loreto Gesualdo, MD Full Prof

    Nephrology, Dialysis and Transplantation Unit "Aldo Moro" University of Bari

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2018

First Posted

January 24, 2019

Study Start

May 24, 2017

Primary Completion

October 17, 2017

Study Completion

October 17, 2017

Last Updated

February 15, 2022

Record last verified: 2018-11

Locations

IT(1)