Chronic kidney disease patients with haemodialysis Urological and Genital Diseases
Conditions
Interventions
This is an interventional study without treatment given to subjects. Stool, plasma and stratum corneum (SC) samples will be collected from 20 healthy subjects and 20 CKD patients undergoing haemodialy
7 days +/- 2 days after V1) reaches 20 in each group and all samples can be collected.
The concentration of putrefactive compounds/uremic toxins, indole, indoxyl sulfate (IS), p-cresol (pCS), trimet
Sponsors
Yakult Honsha (Japan)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent obtained before any study-related activities 2. Female or male aged 18 years or older 3. Only for CKD patients: CKD patients with haemodialysis 4. Is willing and able to collect stool at home 0-5 days before V2, store the samples in appropriate conditions and return the samples within the required timeframe 5. Understand the French language (reading, writing, speaking)
Exclusion criteria
Exclusion criteria: 1. Language barrier, mental or legal incapacity, unwillingness or inability to understand or not being able to participate in the study 2. Has any severe skin disorders such as but not limited to psoriasis, atopic dermatitis, eczema 3. Applied cosmetics to the body sites, which are used as the sampling and analysis area, within 12 hours prior to sampling day (V2) 4. Only for CKD patients: CKD patients without haemodialysis 5. Has an active infection as judged by the investigator 6. Has immunosuppressive therapy 7. Has a body mass index > 35 kg/m2 8. Has inflammatory bowel disease 9. Has an active malignancy 10. Has experienced a cardiovascular event in the past three months prior to V1 11. Has had a transplantation 12. Has used non-steroidal anti-inflammatory drugs within the past one month prior to screening (V1) 13. Has used AST-120 within the past three months prior to V1 14. Use of disallowed concomitant medications and concomitant products 15. Females of child-bearing potential who are pregnant, breastfeeding or are not using adequate contraceptive methods (e.g., oral contraceptive, intrauterine device, abstinence) 16. Any clinically significant disease which in the Investigator’s opinion could interfere with the safety of the study subject or with the results of the study 17. Participation in another interventional clinical study or receipt of any investigational product within 1 month prior to V1 18. Patients who received agents containing cathartic ingredients, such as antibiotics and laxative drugs, within 4 weeks prior to V1 19. Subject has smoking habits (more than 5 cigarettes per day) or alcohol abuse (more than 21 units of alcohol per week) 20. Subject used a chemical peel containing retinoic acid, hydroxy acid, salicylic acid and glycolic acid within one month prior to V2 21. Subjects are vegan 22. Anything that can make SC sample collection difficult (such as having a beard to collect the SC sample from the left cheek)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The concentration of trimethylamine N-oxide (TMAO) and indoxyl sulfate (IS) in SC samples in healthy subjects and CKD patients using ELISA kit and CE-TOF MS and so on at day 0 (V2) | — |
Secondary
| Measure | Time frame |
|---|---|
| The concentration of TMAO and IS in plasma samples in healthy subjects and CKD patients using ELISA kit and CE-TOF MS and so on at day 0 (V2) | — |
Countries
Belgium
Contacts
Public ContactDaisuke Niwa
Outcome results
None listed