Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-01-01 @ 8:14 AM
Study NCT ID:
NCT05061992
Status:
COMPLETED
Last Update Posted:
2023-11-21
First Post:
2021-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Trial to Improve Quality of Life in People With Cirrhosis
Sponsor:
University of Michigan
Organization:
Study Overview
Official Title:
A Trial to Improve Quality of Life in People With Cirrhosis - the Michigan Kristalose Trial
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial is being completed to evaluate whether a crystallized form of lactulose (Kristalose) will improve quality of life, sleep and cognitive function in patients with cirrhosis that have not been diagnosed with Hepatic Encephalopathy (HE), but report reduced quality of life.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: