HemodialysisNATURE32NCT03946176
NATURE 3.2_New Approach for the Reduction of REnal Uremic Toxins
A study testing Symbiotic and DVB cartridge in people with Hemodialysis, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Hemodialysis
- What is being tested?
- Symbiotic and DVB cartridge
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteItaly
- Study dates
- 17 May 2017to 27 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CKD patients on bicarbonate hemodialysis
- Aged between 30 to 65
- BMI between 18.5 and 29.9
- Omnivore diet
- Informed consent signed
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: XUANRO4 - NATURE 3.2 - Nuovo Approccio Per la Riduzione Delle Tossine Uremiche Renali, REGIONE PUGLIA - FSC 2007-2013 Ricerca. Intervento "Cluster Tecnologici Regionali"
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).
Read more
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:
- reduction of blood levels of microbial-derived uremic toxins, involved in cardiovascular complications
- reduction of inflammation markers and oxidative stress and reduction of intestinal permeability
- Conditions
- Hemodialysis
- Being tested
- Symbiotic, Placebo, DVB cartridge
- Keywords
- uremic toxins, gut microbiota dysbiosis, symbiotic, divinylbenzene cartridge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SymbioticDietary supplement
HD patients follow a 8-weeks oral administration of the symbiotic supplement (2 bags/day)
PlaceboDietary supplement
HD patients follow a 8-weeks oral administration of the placebo (2 bags/day)
DVB cartridgeDevice
On the last week of the symbiotic/placebo period, patients undergo 3 dialytic sessions with the DVB cartridge
| Study group | Role | What they receive |
|---|---|---|
| Symbiotic | Experimental | HD patients with 7 weeks symbiotic administration + 1 week overlapping with the 3 dialytic sessions with the DVB cartridge Receives: Dietary Supplement: Symbiotic; Device: DVB cartridge |
| Placebo | Placebo comparator | HD patients with 7 weeks placebo administration + 1 week overlapping with the 3 dialytic sessions with the DVB cartridge Receives: Dietary Supplement: Placebo; Device: DVB cartridge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of serum concentration of pCS
Change of p-cresyl sulfate (pCS) serum concentrations assessed by liquid chromatography/mass spectrometry
Measured: 8 weeks
Secondary outcomes (5)
Change of serum concentration of IS
Change of indoxyl sulfate (IS) serum concentrations assessed by liquid chromatography/mass spectrometry
Measured: 8 weeks
Change of serum concentration of D-lactate
Change of D-lactate serum concentration (uM)
Measured: 8 weeks
Change of serum concentration of LPS
Change of lipopolysaccharide (LPS) serum concentration (EU/ml)
Measured: 8 weeks
Change of serum concentration of inflammatory markers
Change of interleukin (IL)IL10, IL17, pentraxin3 (PTX3) serum concentrations (pg/ml) evaluated by ELISA
Measured: 8 weeks
Change of serum concentration of NO
Change of nitric oxide (NO) serum concentration (uM) evaluated by spectrometry
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2019
- Study start17 May 2017
- Primary completion27 Oct 2017
- Study completion27 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bari Aldo Moro
- Responsible party
- Sponsor
- Investigators
- Loreto Gesualdo, MD Full Prof, Principal investigator, Nephrology, Dialysis and Transplantation Unit "Aldo Moro" University of Bari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03946176
- Sponsor's protocol ID
- XUANRO4-NATURE 3.2
- Acronym
- NATURE32
- Status last verified
- Jan 2019
- First submitted
- 9 May 2019
- Last updated
- 10 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- XUANRO4 - NATURE 3.2 - Nuovo Approccio Per la Riduzione Delle Tossine Uremiche Renali, REGIONE PUGLIA - FSC 2007-2013 Ricerca. Intervento "Cluster Tecnologici Regionali"
- ClinicalTrials.gov ID
- NCT03946176
- Acronym / sponsor ID
- NATURE32 / XUANRO4-NATURE 3.2
- Conditions
- Hemodialysis
- Keywords
- uremic toxins, gut microbiota dysbiosis, symbiotic, divinylbenzene cartridge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di BariUniversity, hospital or other
- Collaborators
- University of Bari Aldo Moro
- Study start
- 17 May 2017 (actual)
- Primary completion
- 27 Oct 2017 (actual)
- Study completion
- 27 Oct 2017 (actual)
- First posted
- 10 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- reduction of blood levels of microbial-derived uremic toxins, involved in cardiovascular complications
- reduction of inflammation markers and oxidative stress and reduction of intestinal permeability
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symbiotic | Experimental | Dietary Supplement: Symbiotic, Device: DVB cartridgeHD patients with 7 weeks symbiotic administration + 1 week overlapping with the 3 dialytic sessions with the DVB cartridge |
| Placebo | Placebo comparator | Dietary Supplement: Placebo, Device: DVB cartridgeHD patients with 7 weeks placebo administration + 1 week overlapping with the 3 dialytic sessions with the DVB cartridge |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- CKD patients on bicarbonate hemodialysis
- Aged between 30 to 65
- BMI between 18.5 and 29.9
- Omnivore diet
- Informed consent signed
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SymbioticHD patients follow a 8-weeks oral administration of the symbiotic supplement (2 bags/day) | Dietary supplement | Symbiotic |
| PlaceboHD patients follow a 8-weeks oral administration of the placebo (2 bags/day) | Dietary supplement | Placebo |
| DVB cartridgeOn the last week of the symbiotic/placebo period, patients undergo 3 dialytic sessions with the DVB cartridge | Device | Placebo, Symbiotic |
Primary outcome
Change of serum concentration of pCS
Time frame: 8 weeks
Change of p-cresyl sulfate (pCS) serum concentrations assessed by liquid chromatography/mass spectrometry
5 secondary outcomes
Change of serum concentration of IS
Time frame: 8 weeks
Change of serum concentration of D-lactate
Time frame: 8 weeks
Change of serum concentration of LPS
Time frame: 8 weeks
Change of serum concentration of inflammatory markers
Time frame: 8 weeks
Change of serum concentration of NO
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
- Individual participant dataSharing planned: Undecided
Related trials for Hemodialysis
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis
Intradialytic Nausea and Vomiting, Chronic Kidney Disease
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
Not yet recruitingPhase 1/2
Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis
End Stage Renal Disease, Fatigue
Active, not recruiting
Group Exercise Program Supported By Audiovisual Media During Hemodialysis
Chronic Kidney Failure, Hemodialysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Loreto Gesualdo, MD Full Prof principal investigator
Nephrology, Dialysis and Transplantation Unit "Aldo Moro" University of Bari
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Symbiotic and DVB cartridge in people with Hemodialysis, run by Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of serum concentration of pCS (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2019.