Cirrhosis Clinical Trial
Official title:
Characterization of Venous Ammonia Levels in Fasted and Fed State in Patients With Cirrhosis After Vegetarian, Vegan and Non-Vegetarian Meals
NCT number | NCT05376488 |
Other study ID # | BAJAJ030 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2022 |
Est. completion date | April 20, 2023 |
Verified date | September 2023 |
Source | Hunter Holmes Mcguire Veteran Affairs Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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. The subjects will also provide stool for microbiome and serum, urine and plasma for metabolomics during this one-time study. Total duration=4 hours
Status | Completed |
Enrollment | 30 |
Est. completion date | April 20, 2023 |
Est. primary completion date | December 20, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Cirrhosis 2. Able and willing to voluntarily complete the informed consent process 3. Available for and agree to all study procedures 4. Consistent non-vegetarian Western dietary patterns for at least a month prior to the study assessed by dietary interview Exclusion Criteria: 1. MELD score > 23 2. Unclear diagnosis of cirrhosis 3. History of liver transplant 4. Body mass index < 18.5 or = 40 kg/m2 5. Prior transjugular intrahepatic portosystemic shunt placement 6. Treatment with systemic (e.g., oral or intravenous) antibiotic (apart from rifaximin) within 4 weeks prior to enrollment 7. For those with HE: stable dose of medications (lactulose or rifaximin) without a recent (<1 month episode of HE) 8. Current use of valproate, corticosteroids, or cytotoxic drugs. 9. 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. |
Country | Name | City | State |
---|---|---|---|
United States | Hunter Holmes McGuire VA Medical Center | Richmond | Virginia |
Lead Sponsor | Collaborator |
---|---|
Hunter Holmes Mcguire Veteran Affairs Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Venous ammonia level | Change in these levels hourly from baseline | 3 hours | |
Secondary | Venous ammonia level | Change in these levels from baseline to hour 1 | 1 hour | |
Secondary | Venous ammonia level | Change in these levels from baseline to hour 2 | 2 hours | |
Secondary | Venous ammonia level | Change in these levels from baseline to hour 3 | 3 hours |
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