Probiotics and Low Protein Diet in Advanced Chronic Kidney Disease
Probiotics-addicted Low-protein Diet for Microbiota Modulation in Patients With Advanced Chronic Kidney Disease (ProLowCKD): a Protocol of Placebo-controlled Randomized Trial
Lead Sponsor: Probiotical S.p.A.
Collaborator: Azienda Ospedaliero Universitaria Maggiore della Carita
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.
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.
|Start Date||March 13, 2017|
|Completion Date||December 31, 2020|
|Primary Completion Date||December 31, 2020|
Intervention Type: Dietary Supplement
Intervention Name: Probiotics
Description: 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.
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
- 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
Minimum Age: 18 Years
Maximum Age: 80 Years
Healthy Volunteers: No
Last Name: Andreana De Mauri, MD
Email: [email protected]
|Has Expanded Access||No|
|Number Of Arms||2|
Type: Active Comparator
Description: Composition: 5x109 of Bifidobacterium longum (mix DLBL), 1x109 Lactobacillus reuteri LRE02 (DSM 23878) and maltodextrin (total 2 grams)
Type: Placebo Comparator
Description: Composition: maltodextrin (2 grams)
|Study Design Info||
Intervention Model: Parallel Assignment
Intervention Model Description: Single-centre, double-blind, placebo-controlled, randomised study.
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)