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Probiotics and Low Protein Diet in Advanced Chronic Kidney Disease

NCT04204005 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-07-05

No results posted yet for this study

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.

Conditions

  • Renal Failure Chronic

Interventions

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.

Sponsors & Collaborators

  • Probiotical S.p.A.

    lead INDUSTRY

  • Azienda Ospedaliero Universitaria Maggiore della Carita

    collaborator OTHER

Principal Investigators

  • Andreana De Mauri · Azienda Ospedaliero Universitaria Maggiore della Carità

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-13
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04204005 on ClinicalTrials.gov