Kidney Injury Clinical Trial
Official title:
Does Probiotic Supplementation Prevent Kidney Injury During Strenuous Physical Exercise?
Severe heat strain arising from intense physical work under climate conditions that does not allow sufficient heat dissipation may lead to heat stroke. This severe conditions is hypothesized to be secondary to increased gut permeability and leakage of bacterial toxins across the gut membrane, stimulating a systematic inflammatory response and associated organ injury. Repeated such sub-clinical increases in gut permeability has been suggested to contribute to the high burden of chronic kidney disease among heat-stressed workers. Many marathon runners experience a transient increase in kidney injury biomarkers while running. Probiotics have been studied as a way to decrease gut permeability and reduce systemic inflammation in many settings, including in athletes . However, no study has measured renal outcomes among workers or athletes performing strenuous activity. This is of interest as it could test the hypothesis that gut-induced inflammation is a driver of kidney injury during heat stress, and could point to a possible intervention to add on to efforts to relieve heat strain. In the present study, recreational or professional runners will be randomized to take a probiotic supplement or placebo during a 4 week period preceding a strenuous physical exercise (minimum 21 km run). Urine samples will be taken before and after the run, and analyzed for markers of renal injury and inflammation.
Participants registered to run in organised half-marathons, marathons and ultramarathons in Southern Sweden will be recruited. They will be asked to abstain from probiotic supplementation (including functional foods with probiotics) for 2 weeks, and then commence a 4-week period of probiotic or placebo supplementation. At the end of the 4 week treatment period, the participants run the race. Urine samples are taken before and after the race and analysed for kidney injury markers. Stool samples are taken by participants at the initiation of the treatment period, last stool before the race, and first stool after the race. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03550794 -
Thiamine as a Renal Protective Agent in Septic Shock
|
Phase 2 | |
Terminated |
NCT04051957 -
Isosorbide Mononitrate For Anti-Vascular Endothelial Growth Factor (VEGF) Induced Kidney Injury
|
Phase 2 | |
Completed |
NCT04933604 -
LPN in Patients With High-complex Renal Tumors
|
||
Recruiting |
NCT05229328 -
Study on the Establishment of a System for Early Warning and Prognostic Evaluation of Patients With Sepsis
|
||
Completed |
NCT02242006 -
Antimicrobial Pharmacokinetics in Critically Ill Adults During Sustained Low Efficiency Dialysis (SLED)
|
||
Terminated |
NCT05747053 -
Personalization of Immunosuppressive Treatment for Organ Transplant Recipients
|
||
Completed |
NCT03407573 -
Restrictive vs Liberal Transfusion Strategy on Cardiac Injury in Patients Undergoing Surgery for Fractured Neck Of Femur
|
N/A | |
Withdrawn |
NCT00793013 -
Airway Pressure Release Ventilation (APRV) Compared to ARDSnet Ventilation
|
Phase 2 | |
Not yet recruiting |
NCT06108765 -
Acute Kidney Injury in Poly Trauma Patients
|
||
Recruiting |
NCT05155358 -
Study on the Establishment of a System for Early Warning and Prognostic Evaluation of Patients With Heat Stroke
|
||
Completed |
NCT06008223 -
Clinical Analysis of Vitamin B6 in Sepsis
|
N/A | |
Completed |
NCT04869462 -
DS Titanium Ligation Clip in Urology (Prostatectomy and Nephrectomy)
|
||
Recruiting |
NCT04626323 -
Randomized Study Comparing Metabolic Surgery With Intensive Medical Therapy to Treat Diabetic Kidney Disease
|
Phase 2 | |
Active, not recruiting |
NCT02037321 -
Meta-Analyses of the Effect of Vegetable Protein for Animal Protein on Cardiometabolic Risk
|
N/A | |
Completed |
NCT00819871 -
Nuclear Factor Kappa-B (NFKB1) Polymorphism and Organ Injury After Cardiac Surgery
|
N/A | |
Recruiting |
NCT05812755 -
SGC Stimulation, Perioperative Vascular Reactivity, and Organ Injury in Cardiac Surgery
|
Phase 4 | |
Recruiting |
NCT04902846 -
Immune Checkpoint Inhibitors Nephrotoxicity
|
||
Recruiting |
NCT04752293 -
Pediatric Hypertension and the Renin-Angiotensin SystEm (PHRASE)
|
||
Completed |
NCT03139123 -
Prevalence of Hypotension Associated With Preload Dependence During Continuous Renal Replacement Therapy
|
||
Completed |
NCT04386564 -
Kidney Injury Severity and COVID-19
|