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

Sponsors

Lead Sponsor: Probiotical S.p.A.

Collaborator: Azienda Ospedaliero Universitaria Maggiore della Carita

Source Probiotical S.p.A.
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.

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.

Overall Status Recruiting
Start Date March 13, 2017
Completion Date December 31, 2020
Primary Completion Date December 31, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change from baseline of the microbial gut populations 5 months
Change from baseline of the microbial inflammatory uremic toxins 5 months
Change from baseline of the markers of cardiovascular diseases 5 months
Change from baseline of the markers of intestinal barrier permeability 5 months
Secondary Outcome
Measure Time Frame
Evaluation of the renal function 5 months
Measurement of the urine protein excretion 5 months
Evaluation of the anemia 5 months
Evaluation of the serum acid-base equilibrium 5 months
Quantification of serum inflammatory markers 5 months
Evaluation of the body composition 5 months
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) 5 months
Enrollment 50
Condition
Intervention

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.

Eligibility

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Andreana De Mauri Principal Investigator Azienda Ospedaliero Universitaria Maggiore della Carità
Overall Contact

Last Name: Andreana De Mauri, MD

Phone: 003903213733918

Email: [email protected]

Location
Facility: Status: Contact: Nephrology and Dialysis Unit, Azienda Ospedaliero Universitaria Maggiore della Carità Andreana De Mauri, MD
Location Countries

Italy

Verification Date

December 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Probiotics

Type: Active Comparator

Description: Composition: 5x109 of Bifidobacterium longum (mix DLBL), 1x109 Lactobacillus reuteri LRE02 (DSM 23878) and maltodextrin (total 2 grams)

Label: Placebo

Type: Placebo Comparator

Description: Composition: maltodextrin (2 grams)

Acronym ProLowCKD
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Single-centre, double-blind, placebo-controlled, randomised study.

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov