Renal Failure Chronic Clinical Trial
— ProLowCKDOfficial title:
Probiotics-addicted Low-protein Diet for Microbiota Modulation in Patients With Advanced Chronic Kidney Disease (ProLowCKD): a Protocol of Placebo-controlled Randomized Trial
Verified date | December 2019 |
Source | Probiotical S.p.A. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | December 31, 2020 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Nephrology and Dialysis Unit, Azienda Ospedaliero Universitaria Maggiore della Carità | Novara |
Lead Sponsor | Collaborator |
---|---|
Probiotical S.p.A. | Azienda Ospedaliero Universitaria Maggiore della Carita |
Italy,
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. — View Citation
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. Review. — View Citation
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. Review. — View Citation
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. Review. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | Change from baseline of the markers of cardiovascular diseases | Change from baseline of the serum concentration of Lp-PLA2 (nmol/ml/min) | 5 months | |
Primary | Change from baseline of the markers of intestinal barrier permeability | Change from baseline of the serum concentration of LPS (EU/ml) | 5 months | |
Secondary | Evaluation of the renal function | Change from baseline of ?GFR (mL/min/m2 of body surface) | 5 months | |
Secondary | Measurement of the urine protein excretion | Change from baseline of 24-hour protein urine excretion (mg/24 hours) | 5 months | |
Secondary | Evaluation of the anemia | Change from baseline of haemoglobin (g/dL) | 5 months | |
Secondary | Evaluation of the serum acid-base equilibrium | Change from baseline of bicarbonatemia (mEq/l) | 5 months | |
Secondary | Quantification of serum inflammatory markers | Change from baseline of the serum concentration of C-reactive protein (CRP) (mg/dL) | 5 months | |
Secondary | Evaluation of the body composition | Change from baseline of fat-free body mass (kg), fat-body mass (kg), Hand Grip strength (kg), total body water (kg) | 5 months | |
Secondary | 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) | Change from baseline of SF36 questionnaire score. The SF36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability. | 5 months |
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