Longitudinal Monitoring of Stool Characteristics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-28

Study Completion Date

2023-10-28

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.

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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.

Conditions

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Cirrhosis, Liver

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy controls

App to monitor stool consistency and symptoms

Intervention Type OTHER

App to monitor stool consistency and symptoms

Patients with cirrhosis on lactulose

App to monitor stool consistency and symptoms

Intervention Type OTHER

App to monitor stool consistency and symptoms

Patients with cirrhosis on rifaximin

App to monitor stool consistency and symptoms

Intervention Type OTHER

App to monitor stool consistency and symptoms

Interventions

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App to monitor stool consistency and symptoms

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Male and female subjects aged ≥ 18 years.
2. Cirrhosis
3. Able and willing to voluntarily complete the informed consent process
4. Familiar with smartphone technology
5. Available for and agree to all study procedures, including taking the pictures of the stool and collection of stool

For controls :

1. Male and female subjects aged ≥ 18 years.
2. Absence of chronic diseases requiring prescription medications
3. Able and willing to voluntarily complete the informed consent process
4. Familiar with smartphone technology
5. 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:

1. Unclear diagnosis of cirrhosis
2. History of liver transplant
3. For those on lactulose, they need to be on it for at least 2 weeks
4. Unfamiliar with smartphones
5. 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

1. Any chronic disease requiring prescription medications
2. Unfamiliar with smartphones

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes