AzTrials
AzTrials

Renal Failure ChronicProLowCKDNCT04204005

Probiotics and Low Protein Diet in Advanced Chronic Kidney Disease

A study testing Probiotics in people with Renal Failure Chronic, run by Probiotical S.p.A. at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Here the investigators will perform a double-blinded randomized placebo-controlled clinical trial to evaluate the synergic effect of low protein diet and prebiotics in reducing the microbial inflammatory uremic toxins. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Renal Failure Chronic
What is being tested?
Probiotics
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteItaly
Study dates
13 Mar 2017to 31 Dec 2020
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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • age 18-80 years
  • GFR < 20 ml/min/sqm
  • afferent to the outpatient clinic in the Nephrology and Dialysis Unit (Azienda Ospedaliero Universitaria Maggiore della Carità)
  • Drop out or Exclusion Criteria:
  • subject refusing to sign the informed consent
  • administration of prolonged antibacterial therapy
  • dialysis initiation
  • death

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

Italy1 site

  • Nephrology and Dialysis Unit, Azienda Ospedaliero Universitaria Maggiore della Carità

    Novara, 28100

Other trials in Italy

About this study

Official title: Probiotics-addicted Low-protein Diet for Microbiota Modulation in Patients With Advanced Chronic Kidney Disease (ProLowCKD): a Protocol of Placebo-controlled Randomized Trial

Here the investigators will perform a double-blinded randomized placebo-controlled clinical trial to evaluate the synergic effect of low protein diet and prebiotics in reducing the microbial inflammatory uremic toxins.

Read the detailed description

ProLowCKD is a single-centre, double-blind, placebo-controlled, randomised study. At enrolment (T0) participants were prescribed a LPD in addition to their ongoing pharmacological therapy and according to their comorbidities; after 2 months (T2) they were randomized in accordance to a 1:1 ratio to receive probiotics or placebo for other 3 months (T5) in addition to the continuation of LPD. Enrolled subjects are invited to assume two doses of probiotic/placebo for 1 month and 1 dose for 2 months.

Randomization is 1:1 to receive odd- or even envelopes, according to the odd- or even registration number at enrolment.

Neither the clinician nor the patient knows the content of the odd- and even envelopes.

The evaluations will be performed according to the following schedule: at T0 nephrological evaluation and biochemical analysis, dietary counselling, illustration of protocol and signing of the informed consent, administration of the SF36 questionnaire, body composition evaluation by bioimpedentiometry. At T0, T2, T5: blood biochemical parameters: haemoglobin, urea, creatinine, mean urea and creatinine clearance, CKD and MDRD calculation, sodium, potassium, uric acid, calcium, phosphate, PTH, acid-base balance, CRP, albumin, PC, IS, Lp-PLA2, LPS; 24h-urine biochemical parameters: urea, creatinine, sodium, proteins; microbial stools analysis; clinical nephrological and dietitian evaluation.

Being tested
Probiotics
Keywords
Low protein diet, Chronic kidney disease, Gut microbiota, Microbial uremic toxins, Probiotic bacteria, Intestinal dysbiosis
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.

  • ProbioticsDietary supplement

    Active composition: 5x109 of Bifidobacterium longum (mix DLBL), 1x 109 Lactobacillus reuteri LRE02 (DSM 23878) and maltodextrin (total 2 grams). The probiotic species employed were granted the Qualified Presumption of Safety (QPS) status by the European Food Safety Authority (EFSA) in 2007. Two envelopes per day and one envelope per day will be recommended for one and two months, respectively.

    Placebo composition: maltodextrin (2 grams). Two envelopes per day and one envelope per day will be recommended for one and two months, respectively.

Study groups in NCT04204005
Study groupRoleWhat they receive
ProbioticsActive comparatorComposition: 5x109 of Bifidobacterium longum (mix DLBL), 1x109 Lactobacillus reuteri LRE02 (DSM 23878) and maltodextrin (total 2 grams)
Receives: Dietary Supplement: Probiotics
PlaceboPlacebo comparatorComposition: maltodextrin (2 grams)
Receives: Dietary Supplement: Probiotics

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline of the microbial gut populations

    • Change from baseline of the concentration of proteolytic microbial groups (number of cells/gram of faeces);
    • Change from baseline of the concentration of saccharolytic microbial groups (number of cells/gram of faeces)

    Measured: 5 months

  2. Change from baseline of the microbial inflammatory uremic toxins

    Change from baseline of the serum concentration of PC (mcMOL) and IS (mcMOL), as markers of dysbiotic microbiota

    Measured: 5 months

  3. Change from baseline of the markers of cardiovascular diseases

    Change from baseline of the serum concentration of Lp-PLA2 (nmol/ml/min)

    Measured: 5 months

  4. Change from baseline of the markers of intestinal barrier permeability

    Change from baseline of the serum concentration of LPS (EU/ml)

    Measured: 5 months

Secondary outcomes (7)

  1. Evaluation of the renal function

    Change from baseline of ΔGFR (mL/min/m2 of body surface)

    Measured: 5 months

  2. Measurement of the urine protein excretion

    Change from baseline of 24-hour protein urine excretion (mg/24 hours)

    Measured: 5 months

  3. Evaluation of the anemia

    Change from baseline of haemoglobin (g/dL)

    Measured: 5 months

  4. Evaluation of the serum acid-base equilibrium

    Change from baseline of bicarbonatemia (mEq/l)

    Measured: 5 months

  5. Quantification of serum inflammatory markers

    Change from baseline of the serum concentration of C-reactive protein (CRP) (mg/dL)

    Measured: 5 months

  6. Evaluation of the body composition

    Change from baseline of fat-free body mass (kg), fat-body mass (kg), Hand Grip strength (kg), total body water (kg)

    Measured: 5 months

  7. Measurement of vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health (Quality of Life)

    Change from baseline of SF36 questionnaire score. The SF36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.

    Measured: 5 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2019
  2. Study start13 Mar 2017
  3. Primary completion31 Dec 2020
  4. Study completion31 Dec 2020

Resources

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
Model description
Single-centre, double-blind, placebo-controlled, randomised study.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04204005
Sponsor's protocol ID
215/CE n.CE 30\17
Acronym
ProLowCKD
Status last verified
Dec 2019
First submitted
29 Nov 2019
Last updated
5 Jul 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Marchesi JR, Adams DH, Fava F, Hermes GD, Hirschfield GM, Hold G, Quraishi MN, Kinross J, Smidt H, Tuohy KM, Thomas LV, Zoetendal EG, Hart A. The gut microbiota and host health: a new clinical frontier. Gut. 2016 Feb;65(2):330-9. doi: 10.1136/gutjnl-2015-309990. Epub 2015 Sep 2.

    PubMed 26338727

  • Ramezani A, Massy ZA, Meijers B, Evenepoel P, Vanholder R, Raj DS. Role of the Gut Microbiome in Uremia: A Potential Therapeutic Target. Am J Kidney Dis. 2016 Mar;67(3):483-98. doi: 10.1053/j.ajkd.2015.09.027. Epub 2015 Nov 15.

    PubMed 26590448

  • Mafra D, Fouque D. Gut microbiota and inflammation in chronic kidney disease patients. Clin Kidney J. 2015 Jun;8(3):332-4. doi: 10.1093/ckj/sfv026. Epub 2015 May 6.

    PubMed 26034597

  • Mafra D, Lobo JC, Barros AF, Koppe L, Vaziri ND, Fouque D. Role of altered intestinal microbiota in systemic inflammation and cardiovascular disease in chronic kidney disease. Future Microbiol. 2014;9(3):399-410. doi: 10.2217/fmb.13.165.

    PubMed 24762311

  • Rossi M, Klein K, Johnson DW, Campbell KL. Pre-, pro-, and synbiotics: do they have a role in reducing uremic toxins? A systematic review and meta-analysis. Int J Nephrol. 2012;2012:673631. doi: 10.1155/2012/673631. Epub 2012 Dec 19.

    PubMed 23316359

  • Vaziri ND. Effect of Synbiotic Therapy on Gut-Derived Uremic Toxins and the Intestinal Microbiome in Patients with CKD. Clin J Am Soc Nephrol. 2016 Feb 5;11(2):199-201. doi: 10.2215/CJN.13631215. Epub 2016 Jan 15. No abstract available.

    PubMed 26772192

  • Cooper TE, Khalid R, Chan S, Craig JC, Hawley CM, Howell M, Johnson DW, Jaure A, Teixeira-Pinto A, Wong G. Synbiotics, prebiotics and probiotics for people with chronic kidney disease. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD013631. doi: 10.1002/14651858.CD013631.pub2.

    PubMed 37870148

Questions about this trial

What is this clinical trial studying?

A study testing Probiotics in people with Renal Failure Chronic, run by Probiotical S.p.A. 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 8 inclusion and 0 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 5 Jul 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. 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 from baseline of the microbial gut populations (time frame: 5 months). The study lists 4 primary outcomes in all. 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 NCT04204005, which also lists 7 linked publications.

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 5 Jul 2022.

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