Longitudinal Monitoring of Stool Characteristics

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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Longitudinal Monitoring of Stool Characteristics

Conditions
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Cirrhosis, Liver

Intervention / Treatment
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* Other: App to monitor stool consistency and symptoms


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy controls<br> | Other: App to monitor stool consistency and symptoms<br>* App to monitor stool consistency and symptoms<br>|
| Patients with cirrhosis on lactulose<br> | Other: App to monitor stool consistency and symptoms<br>* App to monitor stool consistency and symptoms<br>|
| Patients with cirrhosis on rifaximin<br> | Other: App to monitor stool consistency and symptoms<br>* App to monitor stool consistency and symptoms<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| App use comfort measured by survey | A survey designed to assess acceptability of this App at baseline and at 2 weeks; higher score=good | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life using Sickness Impact Profile | we will test association of the stool characteristics with quality of life; higher=good | 2 weeks | 
| Cognitive testing using PHES | we will test association of the stool characteristics with PHES values; higher=good | 2 weeks | 
| Alpha diversity using Shannon index of microbiome | we will test association of the stool characteristics with microbial characteristics | 2 weeks | 
| Bristol stool scale by subjects | we will test association of the stool characteristics gauged through the App versus the Bristol stool scale by subjects | 2 weeks |