Efficacy and safety of elobixibat on constipation in end stage kidney disease patients undergoing hemodialysis: a randomized controlled trial
Phase 3
Completed
- Conditions
- End stage kidney disease patients undergoing hemodialysis with chronic constipationConstipation, Hemodialysis patients, Elobixibat, P-cresol
- Registration Number
- TCTR20230317007
- Lead Sponsor
- Phramongkutklao Hospital
- Brief Summary
Elobixibat is effective and safe for improving constipation symptoms and LDL in ESKD patients undergoing hemodialysis with chronic constipation
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 43
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Stool form 2 weeks Bristol stool form scale chart
- Secondary Outcome Measures
Name Time Method 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