search
Back to results

Effect of Probiotics and Prebiotics in Renal Function in Septic Acute Kidney Injury Patients

Primary Purpose

Acute Kidney Injury, Probiotics, Sepsis

Status
Unknown status
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
Probiotics
Placebo
Sponsored by
Hospital Civil de Guadalajara
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Kidney Injury focused on measuring Acute kidney injury, Probiotics, Sepsis, Shock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Sepsis by SOFA
  • Acute kidney injury by KDIGO

Exclusion Criteria:

  • No presence of sepsis
  • No presence of AKI
  • Age below 18 years
  • Inability or contraindication for oral capsules or probiotics by nasogastric tube

Sites / Locations

  • HCGRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotics. Intervention patients

Placebo group

Arm Description

This patients will receive 2 doses of oral probiotics a day, for seven days

This patients will receive 2 doses of oral placebo a day, for seven days

Outcomes

Primary Outcome Measures

Serum creatinine
Number of participants with significative reduction of serum creatinine concentration from beginning of the intervention

Secondary Outcome Measures

Death
Number of defunctions among the subjects
Renal replacement therapy
Number of participants that initiate renal replacement therapy
Final creatinine
Last recorded serum creatinine concentration
Urinary output (final)
Quantification of urinary output in ml/Kg/hour
Shock days
Use of vasopressor therapy during hospitalization
Recuperation of basal creatinine
Serum creatinine reduction to 25% from basal creatinine
Length of hospitalization
Days of hospitalization

Full Information

First Posted
March 12, 2019
Last Updated
August 24, 2021
Sponsor
Hospital Civil de Guadalajara
search

1. Study Identification

Unique Protocol Identification Number
NCT03877081
Brief Title
Effect of Probiotics and Prebiotics in Renal Function in Septic Acute Kidney Injury Patients
Official Title
Effect of Probiotics and Prebiotics in Renal Function in Septic Acute Kidney Injury Patients, Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 4, 2019 (Actual)
Primary Completion Date
September 4, 2022 (Anticipated)
Study Completion Date
February 4, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Civil de Guadalajara

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Septic acute kidney injury is a condition associated with highly related to inflammatory molecules. Prebiotics and probiotics have shown to improve inflammatory cascade in animal model; In this study, the investigators propose the use of probiotics to improve the clinical evolution of septic acute kidney injury patients.
Detailed Description
Acute kidney injury is most commonly caused by sepsis, where endotoxemia and an expanding inflammatory reaction play a key role in its pathogenesis, when this condition is present it is highly related to poor clinical outcomes and higher mortality rates. There is no current specific treatment, and the therapeutic approach is more orientated to complication management. In this study, the investigators propose the use of probiotics to improve the clinical evolution of septic acute kidney injury patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Kidney Injury, Probiotics, Sepsis
Keywords
Acute kidney injury, Probiotics, Sepsis, Shock

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Double blind randomized controlled trial
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probiotics. Intervention patients
Arm Type
Experimental
Arm Description
This patients will receive 2 doses of oral probiotics a day, for seven days
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
This patients will receive 2 doses of oral placebo a day, for seven days
Intervention Type
Biological
Intervention Name(s)
Probiotics
Intervention Description
Administration of oral probiotics with 2 doses a day
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Administration of oral placebo with 2 doses a day
Primary Outcome Measure Information:
Title
Serum creatinine
Description
Number of participants with significative reduction of serum creatinine concentration from beginning of the intervention
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Death
Description
Number of defunctions among the subjects
Time Frame
7 days
Title
Renal replacement therapy
Description
Number of participants that initiate renal replacement therapy
Time Frame
7 days
Title
Final creatinine
Description
Last recorded serum creatinine concentration
Time Frame
7 days
Title
Urinary output (final)
Description
Quantification of urinary output in ml/Kg/hour
Time Frame
7 days
Title
Shock days
Description
Use of vasopressor therapy during hospitalization
Time Frame
7 days
Title
Recuperation of basal creatinine
Description
Serum creatinine reduction to 25% from basal creatinine
Time Frame
7 days
Title
Length of hospitalization
Description
Days of hospitalization
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Sepsis by SOFA Acute kidney injury by KDIGO Exclusion Criteria: No presence of sepsis No presence of AKI Age below 18 years Inability or contraindication for oral capsules or probiotics by nasogastric tube
Facility Information:
Facility Name
HCG
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44240
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Samuel Chavez
Phone
3313299609
Email
jonarchi_10@hotmail.com
First Name & Middle Initial & Last Name & Degree
Jonathan S Chavez-Iniguez, MD
First Name & Middle Initial & Last Name & Degree
Guillermo Garcia-Garcia, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23727171
Citation
Lameire NH, Bagga A, Cruz D, De Maeseneer J, Endre Z, Kellum JA, Liu KD, Mehta RL, Pannu N, Van Biesen W, Vanholder R. Acute kidney injury: an increasing global concern. Lancet. 2013 Jul 13;382(9887):170-9. doi: 10.1016/S0140-6736(13)60647-9. Epub 2013 May 31.
Results Reference
background
PubMed Identifier
25229340
Citation
Siew ED, Davenport A. The growth of acute kidney injury: a rising tide or just closer attention to detail? Kidney Int. 2015 Jan;87(1):46-61. doi: 10.1038/ki.2014.293. Epub 2014 Sep 17.
Results Reference
background
PubMed Identifier
20032961
Citation
Murugan R, Karajala-Subramanyam V, Lee M, Yende S, Kong L, Carter M, Angus DC, Kellum JA; Genetic and Inflammatory Markers of Sepsis (GenIMS) Investigators. Acute kidney injury in non-severe pneumonia is associated with an increased immune response and lower survival. Kidney Int. 2010 Mar;77(6):527-35. doi: 10.1038/ki.2009.502. Epub 2009 Dec 23.
Results Reference
background
PubMed Identifier
23291734
Citation
Nisula S, Kaukonen KM, Vaara ST, Korhonen AM, Poukkanen M, Karlsson S, Haapio M, Inkinen O, Parviainen I, Suojaranta-Ylinen R, Laurila JJ, Tenhunen J, Reinikainen M, Ala-Kokko T, Ruokonen E, Kuitunen A, Pettila V; FINNAKI Study Group. Incidence, risk factors and 90-day mortality of patients with acute kidney injury in Finnish intensive care units: the FINNAKI study. Intensive Care Med. 2013 Mar;39(3):420-8. doi: 10.1007/s00134-012-2796-5. Epub 2013 Jan 5. Erratum In: Intensive Care Med. 2013 Apr;39(4):798.
Results Reference
background
PubMed Identifier
17962378
Citation
Bagshaw SM, George C, Dinu I, Bellomo R. A multi-centre evaluation of the RIFLE criteria for early acute kidney injury in critically ill patients. Nephrol Dial Transplant. 2008 Apr;23(4):1203-10. doi: 10.1093/ndt/gfm744. Epub 2007 Oct 25.
Results Reference
background
PubMed Identifier
17581483
Citation
Ostermann M, Chang RW. Acute kidney injury in the intensive care unit according to RIFLE. Crit Care Med. 2007 Aug;35(8):1837-43; quiz 1852. doi: 10.1097/01.CCM.0000277041.13090.0A.
Results Reference
background
PubMed Identifier
16696865
Citation
Hoste EA, Clermont G, Kersten A, Venkataraman R, Angus DC, De Bacquer D, Kellum JA. RIFLE criteria for acute kidney injury are associated with hospital mortality in critically ill patients: a cohort analysis. Crit Care. 2006;10(3):R73. doi: 10.1186/cc4915. Epub 2006 May 12.
Results Reference
background
PubMed Identifier
26162677
Citation
Hoste EA, Bagshaw SM, Bellomo R, Cely CM, Colman R, Cruz DN, Edipidis K, Forni LG, Gomersall CD, Govil D, Honore PM, Joannes-Boyau O, Joannidis M, Korhonen AM, Lavrentieva A, Mehta RL, Palevsky P, Roessler E, Ronco C, Uchino S, Vazquez JA, Vidal Andrade E, Webb S, Kellum JA. Epidemiology of acute kidney injury in critically ill patients: the multinational AKI-EPI study. Intensive Care Med. 2015 Aug;41(8):1411-23. doi: 10.1007/s00134-015-3934-7. Epub 2015 Jul 11.
Results Reference
background
PubMed Identifier
16424713
Citation
Vincent JL, Sakr Y, Sprung CL, Ranieri VM, Reinhart K, Gerlach H, Moreno R, Carlet J, Le Gall JR, Payen D; Sepsis Occurrence in Acutely Ill Patients Investigators. Sepsis in European intensive care units: results of the SOAP study. Crit Care Med. 2006 Feb;34(2):344-53. doi: 10.1097/01.ccm.0000194725.48928.3a.
Results Reference
background
PubMed Identifier
21430640
Citation
Chawla LS, Amdur RL, Amodeo S, Kimmel PL, Palant CE. The severity of acute kidney injury predicts progression to chronic kidney disease. Kidney Int. 2011 Jun;79(12):1361-9. doi: 10.1038/ki.2011.42. Epub 2011 Mar 23.
Results Reference
background
PubMed Identifier
22473149
Citation
Wang HE, Muntner P, Chertow GM, Warnock DG. Acute kidney injury and mortality in hospitalized patients. Am J Nephrol. 2012;35(4):349-55. doi: 10.1159/000337487. Epub 2012 Apr 2.
Results Reference
background
PubMed Identifier
21566052
Citation
Zarjou A, Agarwal A. Sepsis and acute kidney injury. J Am Soc Nephrol. 2011 Jun;22(6):999-1006. doi: 10.1681/ASN.2010050484. Epub 2011 May 12.
Results Reference
background
PubMed Identifier
24346647
Citation
Gomez H, Ince C, De Backer D, Pickkers P, Payen D, Hotchkiss J, Kellum JA. A unified theory of sepsis-induced acute kidney injury: inflammation, microcirculatory dysfunction, bioenergetics, and the tubular cell adaptation to injury. Shock. 2014 Jan;41(1):3-11. doi: 10.1097/SHK.0000000000000052.
Results Reference
background
PubMed Identifier
21152901
Citation
Mehta RL, Bouchard J, Soroko SB, Ikizler TA, Paganini EP, Chertow GM, Himmelfarb J; Program to Improve Care in Acute Renal Disease (PICARD) Study Group. Sepsis as a cause and consequence of acute kidney injury: Program to Improve Care in Acute Renal Disease. Intensive Care Med. 2011 Feb;37(2):241-8. doi: 10.1007/s00134-010-2089-9. Epub 2010 Dec 9.
Results Reference
background
PubMed Identifier
30075798
Citation
Peters E, Antonelli M, Wittebole X, Nanchal R, Francois B, Sakr Y, Vincent JL, Pickkers P. A worldwide multicentre evaluation of the influence of deterioration or improvement of acute kidney injury on clinical outcome in critically ill patients with and without sepsis at ICU admission: results from The Intensive Care Over Nations audit. Crit Care. 2018 Aug 3;22(1):188. doi: 10.1186/s13054-018-2112-z.
Results Reference
background
PubMed Identifier
28364303
Citation
Bellomo R, Kellum JA, Ronco C, Wald R, Martensson J, Maiden M, Bagshaw SM, Glassford NJ, Lankadeva Y, Vaara ST, Schneider A. Acute kidney injury in sepsis. Intensive Care Med. 2017 Jun;43(6):816-828. doi: 10.1007/s00134-017-4755-7. Epub 2017 Mar 31.
Results Reference
background
PubMed Identifier
27661757
Citation
Gomez H, Kellum JA. Sepsis-induced acute kidney injury. Curr Opin Crit Care. 2016 Dec;22(6):546-553. doi: 10.1097/MCC.0000000000000356.
Results Reference
background
PubMed Identifier
26976392
Citation
Dellepiane S, Marengo M, Cantaluppi V. Detrimental cross-talk between sepsis and acute kidney injury: new pathogenic mechanisms, early biomarkers and targeted therapies. Crit Care. 2016 Mar 15;20:61. doi: 10.1186/s13054-016-1219-3.
Results Reference
background
PubMed Identifier
18364044
Citation
Mariano F, Cantaluppi V, Stella M, Romanazzi GM, Assenzio B, Cairo M, Biancone L, Triolo G, Ranieri VM, Camussi G. Circulating plasma factors induce tubular and glomerular alterations in septic burns patients. Crit Care. 2008;12(2):R42. doi: 10.1186/cc6848. Epub 2008 Mar 25.
Results Reference
background
PubMed Identifier
28138736
Citation
Pickkers P, Ostermann M, Joannidis M, Zarbock A, Hoste E, Bellomo R, Prowle J, Darmon M, Bonventre JV, Forni L, Bagshaw SM, Schetz M. The intensive care medicine agenda on acute kidney injury. Intensive Care Med. 2017 Sep;43(9):1198-1209. doi: 10.1007/s00134-017-4687-2. Epub 2017 Jan 30.
Results Reference
background
PubMed Identifier
27553986
Citation
Cigarran Guldris S, Gonzalez Parra E, Cases Amenos A. Gut microbiota in chronic kidney disease. Nefrologia. 2017 Jan-Feb;37(1):9-19. doi: 10.1016/j.nefro.2016.05.008. Epub 2016 Aug 21. English, Spanish.
Results Reference
background
PubMed Identifier
25815173
Citation
Vanholder R, Glorieux G. The intestine and the kidneys: a bad marriage can be hazardous. Clin Kidney J. 2015 Apr;8(2):168-79. doi: 10.1093/ckj/sfv004. Epub 2015 Feb 10.
Results Reference
background
PubMed Identifier
19558344
Citation
Ranganathan N, Friedman EA, Tam P, Rao V, Ranganathan P, Dheer R. Probiotic dietary supplementation in patients with stage 3 and 4 chronic kidney disease: a 6-month pilot scale trial in Canada. Curr Med Res Opin. 2009 Aug;25(8):1919-30. doi: 10.1185/03007990903069249.
Results Reference
background
PubMed Identifier
24290319
Citation
Icaza-Chavez ME. [Gut microbiota in health and disease]. Rev Gastroenterol Mex. 2013 Oct-Dec;78(4):240-8. doi: 10.1016/j.rgmx.2013.04.004. Epub 2013 Nov 28. Spanish.
Results Reference
background
PubMed Identifier
22992469
Citation
Vaziri ND, Wong J, Pahl M, Piceno YM, Yuan J, DeSantis TZ, Ni Z, Nguyen TH, Andersen GL. Chronic kidney disease alters intestinal microbial flora. Kidney Int. 2013 Feb;83(2):308-15. doi: 10.1038/ki.2012.345. Epub 2012 Sep 19.
Results Reference
background
PubMed Identifier
25147806
Citation
Natarajan R, Pechenyak B, Vyas U, Ranganathan P, Weinberg A, Liang P, Mallappallil MC, Norin AJ, Friedman EA, Saggi SJ. Randomized controlled trial of strain-specific probiotic formulation (Renadyl) in dialysis patients. Biomed Res Int. 2014;2014:568571. doi: 10.1155/2014/568571. Epub 2014 Jul 24.
Results Reference
background
PubMed Identifier
24559003
Citation
Miranda Alatriste PV, Urbina Arronte R, Gomez Espinosa CO, Espinosa Cuevas Mde L. Effect of probiotics on human blood urea levels in patients with chronic renal failure. Nutr Hosp. 2014 Mar 1;29(3):582-90. doi: 10.3305/nh.2014.29.3.7179.
Results Reference
background
PubMed Identifier
26376131
Citation
Koppe L, Mafra D, Fouque D. Probiotics and chronic kidney disease. Kidney Int. 2015 Nov;88(5):958-66. doi: 10.1038/ki.2015.255. Epub 2015 Sep 16.
Results Reference
background
PubMed Identifier
28104104
Citation
Wanchai K, Pongchaidecha A, Chatsudthipong V, Chattipakorn SC, Chattipakorn N, Lungkaphin A. Role of Gastrointestinal Microbiota on Kidney Injury and the Obese Condition. Am J Med Sci. 2017 Jan;353(1):59-69. doi: 10.1016/j.amjms.2016.11.019. Epub 2016 Nov 17.
Results Reference
background
PubMed Identifier
26487672
Citation
Yoshifuji A, Wakino S, Irie J, Tajima T, Hasegawa K, Kanda T, Tokuyama H, Hayashi K, Itoh H. Gut Lactobacillus protects against the progression of renal damage by modulating the gut environment in rats. Nephrol Dial Transplant. 2016 Mar;31(3):401-12. doi: 10.1093/ndt/gfv353. Epub 2015 Oct 20.
Results Reference
background
PubMed Identifier
15648012
Citation
Taki K, Takayama F, Niwa T. Beneficial effects of Bifidobacteria in a gastroresistant seamless capsule on hyperhomocysteinemia in hemodialysis patients. J Ren Nutr. 2005 Jan;15(1):77-80. doi: 10.1053/j.jrn.2004.09.028.
Results Reference
background
PubMed Identifier
12612972
Citation
Takayama F, Taki K, Niwa T. Bifidobacterium in gastro-resistant seamless capsule reduces serum levels of indoxyl sulfate in patients on hemodialysis. Am J Kidney Dis. 2003 Mar;41(3 Suppl 1):S142-5. doi: 10.1053/ajkd.2003.50104.
Results Reference
background
PubMed Identifier
14737993
Citation
Ando Y, Miyata Y, Tanba K, Saito O, Muto S, Kurosu M, Homma S, Kusano E, Asano Y. [Effect of oral intake of an enteric capsule preparation containing Bifidobacterium longum on the progression of chronic renal failure]. Nihon Jinzo Gakkai Shi. 2003;45(8):759-64. Japanese.
Results Reference
background
PubMed Identifier
25874106
Citation
Ogawa T, Shimada M, Nagano N, Ito K, Ando T, Shimomura Y, Ando Y, Otsuka K. Oral administration of Bifidobacterium longum in a gastro-resistant seamless capsule decreases serum phosphate levels in patients receiving haemodialysis. Clin Kidney J. 2012 Aug;5(4):373-4. doi: 10.1093/ckj/sfs072. No abstract available.
Results Reference
background
PubMed Identifier
26300782
Citation
Yang J, Summanen PH, Henning SM, Hsu M, Lam H, Huang J, Tseng CH, Dowd SE, Finegold SM, Heber D, Li Z. Xylooligosaccharide supplementation alters gut bacteria in both healthy and prediabetic adults: a pilot study. Front Physiol. 2015 Aug 7;6:216. doi: 10.3389/fphys.2015.00216. eCollection 2015.
Results Reference
background
PubMed Identifier
24513849
Citation
Finegold SM, Li Z, Summanen PH, Downes J, Thames G, Corbett K, Dowd S, Krak M, Heber D. Xylooligosaccharide increases bifidobacteria but not lactobacilli in human gut microbiota. Food Funct. 2014 Mar;5(3):436-45. doi: 10.1039/c3fo60348b.
Results Reference
background
PubMed Identifier
23394211
Citation
Kellum JA, Lameire N; KDIGO AKI Guideline Work Group. Diagnosis, evaluation, and management of acute kidney injury: a KDIGO summary (Part 1). Crit Care. 2013 Feb 4;17(1):204. doi: 10.1186/cc11454.
Results Reference
background

Learn more about this trial

Effect of Probiotics and Prebiotics in Renal Function in Septic Acute Kidney Injury Patients

We'll reach out to this number within 24 hrs