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Probiotics and Low Protein Diet in Advanced Chronic Kidney Disease (ProLowCKD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04204005
Recruitment Status : Unknown
Verified December 2019 by Probiotical S.p.A..
Recruitment status was:  Recruiting
First Posted : December 18, 2019
Last Update Posted : December 18, 2019
Sponsor:
Collaborator:
Azienda Ospedaliero Universitaria Maggiore della Carita
Information provided by (Responsible Party):
Probiotical S.p.A.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Renal Failure Chronic Dietary Supplement: Probiotics Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Single-centre, double-blind, placebo-controlled, randomised study.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : March 13, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Probiotics
Composition: 5x109 of Bifidobacterium longum (mix DLBL), 1x109 Lactobacillus reuteri LRE02 (DSM 23878) and maltodextrin (total 2 grams)
 Dietary Supplement: Probiotics

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.
Placebo Comparator: Placebo
Composition: maltodextrin (2 grams)
 Dietary Supplement: Probiotics

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.


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline of the microbial gut populations [ Time Frame: 5 months ]
    • 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)

  2. Change from baseline of the microbial inflammatory uremic toxins [ Time Frame: 5 months ]
    Change from baseline of the serum concentration of PC (mcMOL) and IS (mcMOL), as markers of dysbiotic microbiota

  3. Change from baseline of the markers of cardiovascular diseases [ Time Frame: 5 months ]
    Change from baseline of the serum concentration of Lp-PLA2 (nmol/ml/min)

  4. Change from baseline of the markers of intestinal barrier permeability [ Time Frame: 5 months ]
    Change from baseline of the serum concentration of LPS (EU/ml)


Secondary Outcome Measures :
  1. Evaluation of the renal function [ Time Frame: 5 months ]
    Change from baseline of ΔGFR (mL/min/m2 of body surface)

  2. Measurement of the urine protein excretion [ Time Frame: 5 months ]
    Change from baseline of 24-hour protein urine excretion (mg/24 hours)

  3. Evaluation of the anemia [ Time Frame: 5 months ]
    Change from baseline of haemoglobin (g/dL)

  4. Evaluation of the serum acid-base equilibrium [ Time Frame: 5 months ]
    Change from baseline of bicarbonatemia (mEq/l)

  5. Quantification of serum inflammatory markers [ Time Frame: 5 months ]
    Change from baseline of the serum concentration of C-reactive protein (CRP) (mg/dL)

  6. Evaluation of the body composition [ Time Frame: 5 months ]
    Change from baseline of fat-free body mass (kg), fat-body mass (kg), Hand Grip strength (kg), total body water (kg)

  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) [ Time Frame: 5 months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04204005


Contacts
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Contact: Andreana De Mauri, MD 003903213733918 andreanademauri@libero.it

Locations
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Italy
Nephrology and Dialysis Unit, Azienda Ospedaliero Universitaria Maggiore della Carità Recruiting
Novara, Italy, 28100
Contact: Andreana De Mauri, MD         
Sponsors and Collaborators
Probiotical S.p.A.
Azienda Ospedaliero Universitaria Maggiore della Carita
Investigators
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Principal Investigator: Andreana De Mauri Azienda Ospedaliero Universitaria Maggiore della Carità
More Information
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Publications:

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Responsible Party: Probiotical S.p.A.
ClinicalTrials.gov Identifier: NCT04204005    
Other Study ID Numbers: 215/CE n.CE 30\17
First Posted: December 18, 2019    Key Record Dates
Last Update Posted: December 18, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Probiotical S.p.A.:
Low protein diet
Chronic kidney disease
Gut microbiota
 Microbial uremic toxins
Probiotic bacteria
Intestinal dysbiosis
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency