NCT04390347 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Graham-Brown MP, March DS, Churchward DR, Young HM, Dungey M, Lloyd S, Brunskill NJ, Smith AC, McCann GP, Burton JO
Design and methods of CYCLE-HD: improving cardiovascular health in patients with end stage renal disease using a structured programme of exercise: a randomised control trial. BMC Nephrol. 2016 Jul 8;17(1):69. doi: 10.1186/s12882-016-0294-7.
Wang IK, Wu YY, Yang YF, Ting IW, Lin CC, Yen TH, Chen JH, Wang CH, Huang CC, Lin HC
The effect of probiotics on serum levels of cytokine and endotoxin in peritoneal dialysis patients: a randomised, double-blind, placebo-controlled trial. Benef Microbes. 2015;6(4):423-30. doi: 10.3920/BM2014.0088. Epub 2015 Feb 12.

Daily Intake of Lactobacillus Casei Shirota (LcS) Modulates Intestinal Permeability and Decreases Circulating Levels of Endotoxin That Associate With Both Cardiovascular and All-cause Mortality in Haemodialysis Patients

Details for clinical trial NCT04390347

Clinical trial NCT04390347 - References