Track topics on Twitter Track topics that are important to you
The study will compare achieved levels of protein-bound uremic toxins with dialysis using a medium cut-off membrane compared to the treatment by online haemodiafiltration with a high-flux dialysis membrane. In the second phase of the study dietary fiber and short-chain fatty acid intake will be increased to verify a possible additional reduction in the levels of protein bound uremic toxins.
The investigators will carry out a prospective interventional randomised study to compare achieved serum concentrations of selected protein bound uremic toxins by dialysis with a medium cut-off membrane (Theranova, Baxter AG, USA) and online hemodiafiltration with a standard "high-flux" dialysis membrane. In the second phase, both dialysis purification methods will be supplemented by a change in the diet with increase of the daily intake of dietary fiber to 30g and addition of a short-chain fatty acid propionate in the dose of 1 g daily.
The main outcome of the study is the serum concentration of p-cresol sulphate. Secondary outcome is the serum concentration of indoxyl-sulphate and trimethylamine-N-oxide (TMAO). Serum albumin concentration and lean body weight of patients represent safety outcomes for this study.
This investigator-initiated research project has been entirely planned and will be conducted by the clinical researchers in a tertiary University Medical Center Ljubljana.
The study will include 50 chronic prevalent stable dialysis patients in the following periods:
- 2 weeks of wash-in period with standard bicarbonate haemodialysis and standard high-flux dialysis membrane,
- then the patients will be randomized in a 1:1 ratio to either one of the two study arms:
- (interventional study arm) 4 weeks of dialysis with medium cut-off (Theranova) membrane (first phase), then dialysis for 4 weeks with the same membrane and increased fiber intake (second phase),
- (control study arm) 4 weeks of dialysis with a high-flux membrane using on-line haemodiafiltration (first phase) and 4 weeks of high-flux membrane haemodiafiltration and increased fiber intake (second phase),
- finally, all patients will undergo a 4 week wash-out period with a standard bicarbonate haemodialysis using standard high-flux dialysis membrane identical to wash-in period.
Measurement of the study end-points will be carried out at the end of 2-week wash-in period, each 4-week period and at the end of 4 week wash-out period.
End Stage Renal Disease
medium cut-off (MCO) dialysis membrane, Dietary fiber mixture (Plantago Psyllium and Inulin), Sodium propionate
University Medical Center ljubljana
Not yet recruiting
University Medical Centre Ljubljana
Published on BioPortfolio: 2020-02-04T15:51:50-0500
Our purpose is to investigate the impact of the simultaneous use of a new dialysis membrane with higher permeability for medium and protein bound uraemic toxins (medium cut-off dialysis me...
The purpose of this pilot study is to assess the feasibility of a 3-month dietary fiber intervention: 1) engaging adolescents in regularly consuming a dietary fiber preparation (psyllium p...
A double-blind, randomized, placebo-controlled clinical trial examining the efficacy and safety of Fecal Microbiota Transplantation (FMT) and high fiber supplementation in patients with ac...
The purpose of this trial is to study the effect of the association levodopa/carbidopa with plantago ovata husk in Parkinson´s disease patients of recent diagnostic, that are being treate...
The aim of this study is to - Measure the effect on gene expression in leukocytes from a meal rich in oat bran - Investigate the postprandial glucose, insulin and triglyceride resp...
Polysaccharides isolated from natural products, have raised an increasing interest due to their variety of beneficial health effects. Plantago spp., a valuable Chinese herbal plant, has a long history...
The hollow fiber membrane bioreactor (HFMB) has been investigated for the cultivation of mammalian Chinese hamster ovary cell expansion. The experiments were carried out in Petri's dishes and in the h...
A water-soluble polysaccharide (PSPC) was extracted from the seeds of Plantago ciliata Desf., a spontaneous Algerian Saharan plant by a hot aqueous extraction then purified by successive ethanolic pre...
Although antibiotics are commonly used to treat infectious diseases, emergence of antibiotic resistant strains highlights the necessity for developing novel alternative approaches. Meanwhile, clinical...
Glycemic load (GL) reflects the quantity and quality of carbohydrates in the diet; dietary fiber and added sugar are components of GL. Few epidemiologic studies have assessed the association between t...
Dried, ripe seeds of Plantago psyllium, P. indica, and P. ovata (Plantaginaceae). Plantain seeds swell in water and are used as demulcents and bulk laxatives.
A plant genus of the family Plantaginaceae, order Plantaginales, subclass Asteridae, class Magnoliopsida. The small plants usually have a dense tuft of basal leaves and long, leafless stalks bearing a terminal spike of small flowers. The seeds, known as PSYLLIUM, swell in water and are used as laxatives. The leaves have been used medicinally.
Therapy for the insufficient cleansing of the BLOOD by the kidneys based on dialysis and including hemodialysis, PERITONEAL DIALYSIS, and HEMODIAFILTRATION.
Dietary recommendations that promote reduction in or prevention of high blood pressure. Recommendations include increasing intake of fruits and vegetables, and high-fiber, low-fat foods and reducing the intake of DIETARY SODIUM and high fat foods.
Portable peritoneal dialysis using the continuous (24 hours a day, 7 days a week) presence of peritoneal dialysis solution in the peritoneal cavity except for periods of drainage and instillation of fresh solution.
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...
In medicine, dialysis is a process for removing waste and excess water from the blood, and is primarily used to provide an artificial replacement for lost kidney function in people with renal failure. Dialysis may be used for those with an acute disturba...