The effect of carboneceous oral adsorbent and synbiotics on the gut microbiome and muscle health in chronic kidney disease patients

Not Applicable

Conditions: Diseases of the genitourinary system

Registration Number: KCT0007834

Lead Sponsor: Seoul Metropolitan Government Seoul National University Boramae Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 180

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: Interventional Study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change of gut microbiome

Secondary Outcome Measures

Name	Time	Method
gait speed, uremic toxins in the serum (indoxyl sulfate, p-cresyl sulfate), markers of inflammation and oxidative stress (TNF- a, IL-6, myostatin, MDA (malondialdehyde)), physical activity, quality of life