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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0007834

Enrollment

180

Registered

2022-10-21

Start date

2023-01-02

Completion date

Unknown

Last updated

2022-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug, Dietary Supplement : Control group: conventional treatment for dialysis-independent chronic kidney disease patients AST-120 group: AST-120 (Kremezin®, HK inno.N, Corp., 6 g/day) ingestion combi

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: exclude for any of the following reasons 1) BMI = 30 or 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

Design outcomes

Primary

Measure	Time frame
Change of gut microbiome	—

Secondary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public ContactRan-hui Cha

National Medical Center

reginaprayer@gmail.com+82-2-2262-4885

Outcome results