Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy controls |
| ||
| Patients with cirrhosis on lactulose |
| ||
| Patients with cirrhosis on rifaximin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| App to monitor stool consistency and symptoms | Other | App to monitor stool consistency and symptoms |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
For cirrhosis subjects must meet all of the following inclusion criteria to be eligible:
For controls :
Exclusion Criteria:
Subjects with cirrhosis meeting any of the following criteria are not eligible for study enrollment:
For healthy controls
Not provided
Not provided
Not provided
Subjects will be identified through word of mouth or through clinic evaluations and approached to participate in this study. Their medications, clinical and medical history will be recorded to determine eligibility.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunter Holmes McGuire VA Medical Center | Richmond | Virginia | 23249 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38153339 | Derived | Fagan A, Gallagher ML, Mousel T, Davis BC, Fuchs M, Puri P, Anstey J, Tiede D, Simonetto DA, Kraus A, Bajaj JS. Artificial Intelligence Evaluation of Stool Quality Guides Management of Hepatic Encephalopathy Using a Smartphone App. Am J Gastroenterol. 2024 May 1;119(5):977-981. doi: 10.14309/ajg.0000000000002646. Epub 2023 Dec 28. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 7, 2023 | Oct 23, 2024 | ICF_000.pdf |
Not provided
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
Microbiome analysis
| 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |