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

Probiotical

Status: Completed

Conditions: Renal Failure Chronic

Treatments: Dietary Supplement: Probiotics

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04204005

215/CE n.CE 30\17

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups, including a placebo group

Probiotics

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Probiotics

Placebo

Placebo Comparator group

Description:

Composition: maltodextrin (2 grams)

Treatment:

Dietary Supplement: Probiotics