Effect of AST-120 and synbiotics on the gut microbiome and the muscle health in dialysis independent chronic kidney disease patients, a randomized-controlled trial

Seoul Metropolitan Government Seoul National University Boramae Medical Center0 个研究点目标入组 180 人开始时间: 待定最近更新: 2022年11月28日

试验速览

暂无简介。

•include only if all of the following criteria apply
•1) age = 20 years
•2) all cause of chronic kidney disease patients with the serum creatinine level between 2.0 and 5.0 mg/dl
•3) measured or anticipated change of estimated GFR < 6 ml/min/1.73m2
•4) naive to oral carboneceous adsorbent (AST-120), prebiotics, probiotics, synbiotics, and postbiotics 4 weeks prior to the screening
•5) written informed consents

•exclude for any of the following reasons
•1) BMI = 30 or < 18.5 (kg/m2)
•2) HbA1c > 10%
•3) spot urine protein/creatinine ratio > 5,000 mg/g Cr
•4) gastrointestinal transit disorder or uncontrolled constipation
•5) irritable bowel syndrome, Crohn's disease, or ulcerative colitis
•6) severe malnutrition determined by the investigator
•7) taking immunosuppressants due to kidney transplantation or other diseases
•8) history of radiation therapy to the area including colons or underwent the colectomy
•9) expected to receive dialysis or kidney transplantation within 6 months after the enrollment
•10) received antibiotics treatment 1 month prior to the screening
•11) active infection
•12) malignancies (except for malignancies which did not recur more than 5 years after the completion of treatment or regular follow up without any treatment after complete remission)
•13) pregnant or lactating woman, or woman who did not agree with the contraception during the study period
•14) participation in another clinical study
•15) researcher’s decision regarding inappropriateness of enrollment in the study

发起方

Seoul Metropolitan Government Seoul National University Boramae Medical Center