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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.
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. Patients with cirrhosis are often treated with lactulose, that needs monitoring of bowel movement numbers and is overall not acceptable to a majority of patients. The estimation of this number is not completely accurate and varies day by day. In addition, recent work has shown that consistency of the stools with the Bristol Stool Scale (BSS) may be another important metric to determine who will respond well to lactulose versus not. In addition to the issue of remembering exact details of bowel movement frequency, it is often hard for patients, especially with HE, to remember details of their daily function. Additionally, insight into the impact of the disease. Traditionally, patients assess stool form and consistency using the Bristol stool score and chart, which classifies stool into one of seven types. A challenge with this is that the assessment is subjective and may vary from patient to patient. This is seen in patients without cognitive dysfunction such as those with irritable bowel syndrome (IBS). Therefore, it is likely that patients with cirrhosis, who often have cognitive dysfunction, could be worse in estimating stool consistency. In addition, microbiome structure and function, which is often dependent on stool consistency may be measured differently based on personal vs app-generated BSS values. Thus, method to better estimate stool characteristics, which could better inform patient management through telemedicine is needed. Aim: Monitor patients using a mobile health application designed for monitoring and assessing patients with digestive diseases.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States
Start Date
October 28, 2022
Primary Completion Date
October 28, 2023
Completion Date
October 28, 2023
Last Updated
February 13, 2025
60
ACTUAL participants
App to monitor stool consistency and symptoms
OTHER
Lead Sponsor
Hunter Holmes Mcguire Veteran Affairs Medical Center
NCT07343037
NCT05982769
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT03208868