End stage kidney disease patients undergoing hemodialysis with chronic constipation Constipation, Hemodialysis patients, Elobixibat, P-cresol
Conditions
Interventions
Elobixibat (15 mg) 2 tablets once daily,Placebo 2 tablets once daily
Active Comparator Drug,Placebo Comparator Drug
Elobixibat,Placebo
Sponsors
Phramongkutklao Hospital
Eligibility
Sex/Gender
All
Age
20 Years to 80 Years
Inclusion criteria
Inclusion criteria: Age >=20 years ESKD on hemodialysis > 3 months Adequate dialysis (spKT/V>1.2) Consistent with the ROME IV criteria for the diagnosis of functional constipation Signed informed consent
Exclusion criteria
Exclusion criteria: Organic constipation such as mechanical gut obstruction, spinal cord injury Irritable bowel syndrome History of abdominal radiation Medical illness: cancer, cirrhosis, biliary tract obstruction, sepsis Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stool form 2 weeks Bristol stool form scale chart | — |
Secondary
| Measure | Time frame |
|---|---|
| Stool form 12 weeks Bristol stool form scale,Frequency of spontaneous bowel movement 12 weeks Interview,Frequency of complete spontaneous bowel movement 12 weeks Interview,Hematologic and biochemical test 12 weeks Blood test,P-cresol level 2 and 12 weeks Blood test,Adverse event 2 and 12 weeks interview | — |
Countries
Thailand
Contacts
Public ContactKrisanapol Jenaksornkul
Phramongkutklao hospital
Outcome results
None listed