Longitudinal Monitoring of Stool Characteristics
Completed
Conditions studied: Cirrhosis, Liver
In brief
In patients with cirrhosis and healthy controls to determine the utility of an App to classify BSS compared to assessment made by the patients themselves using the BSS and correlate these with other stool characteristics and gut microbiota.
Key facts
- Study ID
- NCT05604274
- Run by
- Hunter Holmes Mcguire Veteran Affairs Medical Center
- People needed
- 60
- Starts
- 2022-10-28
- Expected to finish
- 2023-10-28
- Last updated by the study team
- 2025-02-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- For cirrhosis subjects must meet all of the following inclusion criteria to be eligible:
- Male and female subjects aged ≥ 18 years.
- Cirrhosis
- Able and willing to voluntarily complete the informed consent process
- Familiar with smartphone technology
- Available for and agree to all study procedures, including taking the pictures of the stool and collection of stool
- For controls :
- Male and female subjects aged ≥ 18 years.
- Absence of chronic diseases requiring prescription medications
- Able and willing to voluntarily complete the informed consent process
- Familiar with smartphone technology
- Available for and agree to all study procedures, including taking the pictures of the stool and collection of stool for microbiome analysis
You may not qualify if…
- Subjects with cirrhosis meeting any of the following criteria are not eligible for study enrollment:
- Unclear diagnosis of cirrhosis
- History of liver transplant
- For those on lactulose, they need to be on it for at least 2 weeks
- Unfamiliar with smartphones
- 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.
- For healthy controls
- Any chronic disease requiring prescription medications
- Unfamiliar with smartphones
Where it is running
- Hunter Holmes McGuire VA Medical Center — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
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