Randomized clinical trial of the effect of synbiotics on gut flora and uremia in end-stage renal disease patients
- Conditions
- chronic kidney disease
- Registration Number
- JPRN-UMIN000033020
- Lead Sponsor
- ShonanKamakura General Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 76
Not provided
1) Patients who received antibacterial treatment by oral or intravenous administration within 1 week before the introduction of dialysis 2) Patients who ingested the study drug of this study or similar substances within 1 week before the introduction of dialysis 3) Patients who received or ingested lactic acid bacteria-containing preparations or oligosaccharide preparations manufactured by Yakult Co., Ltd. within 2 weeks before the introduction of dialysis. 4) Patients who used an intestinal regulator or an oral medical spherical adsorption charcoal within 2 weeks before the introduction of dialysis 5) Patients taking immunosuppressive agents within 6 months before the introduction of dialysis 6) Patients with acute renal failure 7) Patients who have had a kidney transplant before 8) Patients with irritable bowel syndrome, Crohn's disease, ulcerative colitis 9) Patients who have been allergic to milk 10) Pregnant or potentially pregnant women 11) Breastfeeding women 12) Patients who received another study drug or study drug within 3 months before the start of administration of the study drug
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The variation in blood concentrations of p-cresol is measured before initiation of dialysis and four weeks after initiation. Participants are randomized to symbiotic intake or no treatment. After four weeks intervention, the changes in blood P cresol values are compared.
- Secondary Outcome Measures
Name Time Method