Skip to main content
OpenTrials
Completed

NCT Number: NCT04204005

Probiotics and Low Protein Diet in Advanced Chronic Kidney Disease

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Renal Failure Chronic Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nephrology and Dialysis Unit, Azienda Ospedaliero Universitaria Maggiore della Carità

Novara, 28100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotics

Dietary 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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Probiotical S.p.A.

Industry

Collaborators

  • Azienda Ospedaliero Universitaria Maggiore della Carita

Registry information

Official study title

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

Acronym: ProLowCKD

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 18, 2019
Registry last updated
Jul 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.