Chronic Kidney DiseasesNATURE31NCT03815786
NATURE 3.1_New Approach for the Reduction of REnal Uremic Toxins
A study testing Symbiotic in people with Chronic Kidney Diseases and Healthy, 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 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… Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases, Healthy
- What is being tested?
- Symbiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 24 May 2017to 17 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- Healthy subjects
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- 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
Who cannot join
- 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
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- Treatment with corticosteroids or immunosuppressive drugs
- Previous acute cardiovascular diseases (myocardial infarction, stroke)
- Psychiatric conditions reducing the compliance to treatment protocols
- Healthy volunteers
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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:
- Reduction of the serum levels of microbiota-derived uremic toxins, involved in a variety of cardiovascular complications in CKD
- Reduction of intestinal permeability, inflammatory markers and oxidative stress
- Conditions
- Chronic Kidney Diseases, Healthy
- Being tested
- Symbiotic, Placebo
- Keywords
- gut microbiota dysbiosis, uremic toxins, symbiotic
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SymbioticDietary supplement
2-months oral administration of the symbiotic supplement (2 bags/day) + 1 month washout
PlaceboDietary supplement
2-months oral administration of the placebo (2 bags/day) + 1 month washout
| Study group | Role | What they receive |
|---|---|---|
| CKD patients | Experimental | CKD patients stage 3b-4 will follow a 2-months supplementation of either symbiotic or placebo Receives: Dietary Supplement: Symbiotic; Dietary Supplement: Placebo |
| Controls | Other | Healthy volunteers will follow a 2-months supplementation of either symbiotic or placebo Receives: Dietary Supplement: Symbiotic; Dietary Supplement: Placebo |
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: 3 months
Secondary outcomes (6)
Change of serum concentration of IS
Change of indoxyl sulfate (IS) serum concentrations assessed by liquid chromatography/mass spectrometry
Measured: 3 months
Change of serum concentration of D-lactate
Change of D-lactate serum concentration (uM)
Measured: 3 months
Change of serum concentration of LPS
Change of lipopolysaccharide (LPS) serum concentration (EU/ml)
Measured: 3 months
Change of percentage of sugar urinary recovery
Change of percentage (%) of urinary recovery of 4 sugars (lactulose, mannitol, sucrose and sucralose)
Measured: 3 months
Change of serum concentration of inflammatory markers
Change of interleukin (IL)6, IL10, IL17, pentraxin3 (PTX3) serum concentrations (pg/ml) evaluated by ELISA
Measured: 3 months
Change of serum concentration of NO
Change of nitric oxide (NO) serum concentration (uM) evaluated by spectrometry
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start24 May 2017
- Primary completion17 Oct 2017
- Study completion17 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 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
- NCT03815786
- Sponsor's protocol ID
- XUANRO4-NATURE 3.1
- Acronym
- NATURE31
- Status last verified
- Nov 2018
- First submitted
- 23 Nov 2018
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37396126
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03815786
- Acronym / sponsor ID
- NATURE31 / XUANRO4-NATURE 3.1
- Conditions
- Chronic Kidney Diseases, Healthy
- Keywords
- gut microbiota dysbiosis, uremic toxins, symbiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di BariUniversity, hospital or other
- Collaborators
- University of Bari Aldo Moro
- Study start
- 24 May 2017 (actual)
- Primary completion
- 17 Oct 2017 (actual)
- Study completion
- 17 Oct 2017 (actual)
- First posted
- 24 Jan 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 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:
- Reduction of the serum levels of microbiota-derived uremic toxins, involved in a variety of cardiovascular complications in CKD
- Reduction of intestinal permeability, inflammatory markers and oxidative stress
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CKD patients | Experimental | Dietary Supplement: Symbiotic, Dietary Supplement: PlaceboCKD patients stage 3b-4 will follow a 2-months supplementation of either symbiotic or placebo |
| Controls | Other | Dietary Supplement: Symbiotic, Dietary Supplement: PlaceboHealthy volunteers will follow a 2-months supplementation of either symbiotic or placebo |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (19 listed)
- 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
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 |
|---|---|---|
| Symbiotic2-months oral administration of the symbiotic supplement (2 bags/day) + 1 month washout | Dietary supplement | CKD patients, Controls |
| Placebo2-months oral administration of the placebo (2 bags/day) + 1 month washout | Dietary supplement | CKD patients, Controls |
Primary outcome
Change of serum concentration of pCS
Time frame: 3 months
Change of p-cresyl sulfate (pCS) serum concentrations assessed by liquid chromatography/mass spectrometry
6 secondary outcomes
Change of serum concentration of IS
Time frame: 3 months
Change of serum concentration of D-lactate
Time frame: 3 months
Change of serum concentration of LPS
Time frame: 3 months
Change of percentage of sugar urinary recovery
Time frame: 3 months
Change of serum concentration of inflammatory markers
Time frame: 3 months
Change of serum concentration of NO
Time frame: 3 months
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 15 Feb 2022.
- Derived from this study: PubMed 37396126Vacca 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.
- Individual participant dataSharing planned: Undecided
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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 in people with Chronic Kidney Diseases and Healthy, 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 10 inclusion and 19 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 15 Feb 2022. 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. 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: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03815786, which also lists 1 linked publication.
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 15 Feb 2022.