Status:
COMPLETED
Effect of Brief Dietary Intervention on Ammonia Levels
Lead Sponsor:
Hunter Holmes Mcguire Veteran Affairs Medical Center
Conditions:
Cirrhosis
Hepatic Encephalopathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Study the impact of differing meal contents on venous ammonia levels over time in patients with cirrhosis. Patients will be given specific meals and venous ammonia analyzed over time after those meals...
Detailed Description
Patient will be instructed to collect stool for baseline assessments. After a fast (\>4h from last meal) a venous blood sample will be drawn for analysis of baseline laboratory tests and spot venous a...
Eligibility Criteria
Inclusion
- Cirrhosis
- Able and willing to voluntarily complete the informed consent process
- Available for and agree to all study procedures
- Consistent non-vegetarian Western dietary patterns for at least a month prior to the study assessed by dietary interview
Exclusion
- MELD score \> 23
- Unclear diagnosis of cirrhosis
- History of liver transplant
- Body mass index \< 18.5 or ≥ 40 kg/m2
- Prior transjugular intrahepatic portosystemic shunt placement
- Treatment with systemic (e.g., oral or intravenous) antibiotic (apart from rifaximin) within 4 weeks prior to enrollment
- For those with HE: stable dose of medications (lactulose or rifaximin) without a recent (\<1 month episode of HE)
- Current use of valproate, corticosteroids, or cytotoxic drugs.
- Apart from chronic liver disease, any acute or chronic medical, surgical, psychiatric, or social condition including history of cerebrovascular disease (stroke, transient ischemic attack) or dementia, that may increase the subject risk associated with study participation, compromise adherence to study procedures and requirements, confound interpretation of the results, and, in the judgment of the investigator, make the subject inappropriate for enrollment.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05376488
Start Date
May 1 2022
End Date
April 20 2023
Last Update
February 13 2025
Active Locations (1)
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1
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States, 23249