NCT03946176

Brief Summary

The objective of the pilot study is to validate a combined approach based on the use of an innovative symbiotic and an innovative dialysis cartridge in patients on hemodialysis (HD). 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. 1.reduction of blood levels of microbial-derived uremic toxins, involved in cardiovascular complications
  2. 2.reduction of inflammation markers and oxidative stress and reduction of intestinal permeability

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 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 17, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 27, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2017

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 10, 2019

Completed
Last Updated

May 10, 2019

Status Verified

January 1, 2019

Enrollment Period

5 months

First QC Date

May 9, 2019

Last Update Submit

May 9, 2019

Conditions

Hemodialysis

Keywords

uremic toxinsgut microbiota dysbiosissymbioticdivinylbenzene cartridge

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

    8 weeks

Secondary Outcomes (5)

  • Change of serum concentration of IS

    8 weeks

  • Change of serum concentration of D-lactate

    8 weeks

  • Change of serum concentration of LPS

    8 weeks

  • Change of serum concentration of inflammatory markers

    8 weeks

  • Change of serum concentration of NO

    8 weeks

Other Outcomes (4)

  • Gut microbiota

    8 weeks

  • Change of GI symptoms

    8 weeks

  • Change of stool type

    8 weeks

  • +1 more other outcomes

Study Arms (2)

Symbiotic

EXPERIMENTAL

HD patients with 7 weeks symbiotic administration + 1 week overlapping with the 3 dialytic sessions with the DVB cartridge

Dietary Supplement: SymbioticDevice: DVB cartridge

Placebo

PLACEBO COMPARATOR

HD patients with 7 weeks placebo administration + 1 week overlapping with the 3 dialytic sessions with the DVB cartridge

Dietary Supplement: PlaceboDevice: DVB cartridge

Interventions

SymbioticDIETARY_SUPPLEMENT

HD patients follow a 8-weeks oral administration of the symbiotic supplement (2 bags/day)

Symbiotic
PlaceboDIETARY_SUPPLEMENT

HD patients follow a 8-weeks oral administration of the placebo (2 bags/day)

Placebo
DVB cartridgeDEVICE

On the last week of the symbiotic/placebo period, patients undergo 3 dialytic sessions with the DVB cartridge

PlaceboSymbiotic

Eligibility Criteria

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

You may qualify if:

  • CKD patients on bicarbonate hemodialysis
  • Aged between 30 to 65
  • BMI between 18.5 and 29.9
  • Omnivore diet
  • Informed consent signed

You may not qualify if:

  • 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
  • Psychiatric conditions reducing the compliance to treatment protocols

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AOUConsorziale Policlinico Di Bari

Bari, 70124, Italy

Location

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
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2019

First Posted

May 10, 2019

Study Start

May 17, 2017

Primary Completion

October 27, 2017

Study Completion

October 27, 2017

Last Updated

May 10, 2019

Record last verified: 2019-01

Locations

IT(1)