Probiotics and Low Protein Diet in Advanced Chronic Kidney Disease

NCT04204005 | Completed

• 1 other identifier: 215/CE n.CE 30\17
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Failure Chronic

Keywords

Low protein diet; Chronic kidney disease; Gut microbiota; Microbial uremic toxins; Probiotic bacteria; Intestinal dysbiosis

Outcome Measures

Primary Outcomes (4)

• Change from baseline of the microbial gut populations

  * 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)

  5 months

• Change from baseline of the microbial inflammatory uremic toxins

  Change from baseline of the serum concentration of PC (mcMOL) and IS (mcMOL), as markers of dysbiotic microbiota

  5 months

• Change from baseline of the markers of cardiovascular diseases

  Change from baseline of the serum concentration of Lp-PLA2 (nmol/ml/min)

  5 months

• Change from baseline of the markers of intestinal barrier permeability

  Change from baseline of the serum concentration of LPS (EU/ml)

  5 months

Secondary Outcomes (7)

• 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

Study Arms (2)

Probiotics

ACTIVE COMPARATOR

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

Dietary Supplement: Probiotics

Placebo

PLACEBO COMPARATOR

Composition: maltodextrin (2 grams)

Dietary Supplement: Probiotics

Interventions

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.

Placebo; Probiotics

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• subject refusing to sign the informed consent
• administration of prolonged antibacterial therapy
• dialysis initiation
• death

Sponsors & Collaborators

• Probiotical S.p.A.: lead
• Azienda Ospedaliero Universitaria Maggiore della Carita: collaborator

Study Sites (1)

Nephrology and Dialysis Unit, Azienda Ospedaliero Universitaria Maggiore della Carità

Novara, 28100, Italy

Location

Related Publications (7)

• Marchesi JR, Adams DH, Fava F, Hermes GD, Hirschfield GM, Hold G, Quraishi MN, Kinross J, Smidt H, Tuohy KM, Thomas LV, Zoetendal EG, Hart A. The gut microbiota and host health: a new clinical frontier. Gut. 2016 Feb;65(2):330-9. doi: 10.1136/gutjnl-2015-309990. Epub 2015 Sep 2.

  PMID: 26338727 BACKGROUND

• Ramezani A, Massy ZA, Meijers B, Evenepoel P, Vanholder R, Raj DS. Role of the Gut Microbiome in Uremia: A Potential Therapeutic Target. Am J Kidney Dis. 2016 Mar;67(3):483-98. doi: 10.1053/j.ajkd.2015.09.027. Epub 2015 Nov 15.

  PMID: 26590448 BACKGROUND

• Mafra D, Fouque D. Gut microbiota and inflammation in chronic kidney disease patients. Clin Kidney J. 2015 Jun;8(3):332-4. doi: 10.1093/ckj/sfv026. Epub 2015 May 6.

  PMID: 26034597 BACKGROUND

• Mafra D, Lobo JC, Barros AF, Koppe L, Vaziri ND, Fouque D. Role of altered intestinal microbiota in systemic inflammation and cardiovascular disease in chronic kidney disease. Future Microbiol. 2014;9(3):399-410. doi: 10.2217/fmb.13.165.

  PMID: 24762311 BACKGROUND

• Rossi M, Klein K, Johnson DW, Campbell KL. Pre-, pro-, and synbiotics: do they have a role in reducing uremic toxins? A systematic review and meta-analysis. Int J Nephrol. 2012;2012:673631. doi: 10.1155/2012/673631. Epub 2012 Dec 19.

  PMID: 23316359 BACKGROUND

• Vaziri ND. Effect of Synbiotic Therapy on Gut-Derived Uremic Toxins and the Intestinal Microbiome in Patients with CKD. Clin J Am Soc Nephrol. 2016 Feb 5;11(2):199-201. doi: 10.2215/CJN.13631215. Epub 2016 Jan 15. No abstract available.

  PMID: 26772192 BACKGROUND

• Cooper TE, Khalid R, Chan S, Craig JC, Hawley CM, Howell M, Johnson DW, Jaure A, Teixeira-Pinto A, Wong G. Synbiotics, prebiotics and probiotics for people with chronic kidney disease. Cochrane Database Syst Rev. 2023 Oct 23;10(10):CD013631. doi: 10.1002/14651858.CD013631.pub2.

  PMID: 37870148 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Probiotics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Andreana De Mauri

  Azienda Ospedaliero Universitaria Maggiore della Carità

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: November 29, 2019
• First Posted: December 18, 2019
• Study Start: March 13, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: July 5, 2022

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)