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Recruiting NCT05604274

Longitudinal Monitoring of Stool Characteristics

Conditions: Cirrhosis, Liver

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: 1
Enrollment: 60
Sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center

Location: United States

Summary

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.

Eligibility Criteria

Inclusion Criteria:For cirrhosis subjects must meet all of the following inclusion criteria to be eligible:Male and female subjects aged ≥ 18 years.CirrhosisAble and willing to voluntarily complete the informed consent processFamiliar with smartphone technologyAvailable for and agree to all study procedures, including taking the pictures of the stool and collection of stoolFor controls :Male and female subjects aged ≥ 18 years.Absence of chronic diseases requiring prescription medicationsAble and willing to voluntarily complete the informed consent processFamiliar with smartphone technologyAvailable for and agree to all study procedures, including taking the pictures of the stool and collection of stool for microbiome analysisExclusion Criteria:Subjects with cirrhosis meeting any of the following criteria are not eligible for study enrollment:Unclear diagnosis of cirrhosisHistory of liver transplantFor those on lactulose, they need to be on it for at least 2 weeksUnfamiliar with smartphonesApart 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 controlsAny chronic disease requiring prescription medicationsUnfamiliar with smartphones

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05604274). StuddyBuddy aggregates publicly available trial information.