Longitudinal Monitoring of Stool Characteristics

Cirrhosis, Liver Clinical Trial

Official title:

Longitudinal Monitoring of Stool Characteristics

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05604274
• Other study ID #: BAJAJ033
• Status: Recruiting
• Start date: October 28, 2022
• Est. completion date: October 28, 2023

Study information

• Verified date: October 2022
• Source: Hunter Holmes Mcguire Veteran Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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, 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 28, 2023
• Est. primary completion date: October 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• For cirrhosis subjects must meet all of the following inclusion criteria to be eligible:

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

Related Conditions & MeSH terms

• Cirrhosis, Liver
• Liver Cirrhosis

Intervention

Other:
• App to monitor stool consistency and symptoms
App to monitor stool consistency and symptoms

Locations

Country	Name	City	State
United States	Hunter Holmes McGuire VA Medical Center	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Hunter Holmes Mcguire Veteran Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quality of life using Sickness Impact Profile	we will test association of the stool characteristics with quality of life; higher=good	2 weeks
Secondary	Cognitive testing using PHES	we will test association of the stool characteristics with PHES values; higher=good	2 weeks
Secondary	Alpha diversity using Shannon index of microbiome	we will test association of the stool characteristics with microbial characteristics	2 weeks
Secondary	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