Longitudinal Monitoring of Stool Characteristics
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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, we need a method to better estimate stool characteristics, which could better inform patient management through telemedicine. Our aim is to monitor patients using a mobile health application designed for monitoring and assessing patients with digestive diseases.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Healthy controls
|
Other: App to monitor stool consistency and symptoms
App to monitor stool consistency and symptoms
|
| Patients with cirrhosis on lactulose
|
Other: App to monitor stool consistency and symptoms
App to monitor stool consistency and symptoms
|
| Patients with cirrhosis on rifaximin
|
Other: App to monitor stool consistency and symptoms
App to monitor stool consistency and symptoms
|
Outcome Measures
Primary Outcome Measures
- App use comfort measured by TAM survey [2 weeks]
A survey designed to assess acceptability of this App at baseline and at 2 weeks
Secondary Outcome Measures
- Quality of life using Sickness Impact Profile [2 weeks]
we will test association of the stool characteristics with quality of life
- Cognitive testing using PHES [2 weeks]
we will test association of the stool characteristics with PHES values
- Alpha diversity using Shannon index of microbiome [2 weeks]
we will test association of the stool characteristics with microbial characteristics
- Bristol stool scale by subjects [2 weeks]
we will test association of the stool characteristics gauged through the App versus the Bristol stool scale by subjects
Eligibility Criteria
Criteria
Inclusion Criteria:
- For cirrhosis subjects must meet all of the following inclusion criteria to be eligible:
-
Male and female subjects aged ≥ 18 years.
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Cirrhosis
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Able and willing to voluntarily complete the informed consent process
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Familiar with smartphone technology
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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.
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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:
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Unclear diagnosis of cirrhosis
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History of liver transplant
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For those on lactulose, they need to be on it for at least 2 weeks
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Unfamiliar with smartphones
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hunter Holmes McGuire VA Medical Center | Richmond | Virginia | United States | 23249 |
Sponsors and Collaborators
- Hunter Holmes Mcguire Veteran Affairs Medical Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BAJAJ033