Longitudinal Monitoring of Stool Characteristics

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.

Study Overview

• Status: Recruiting
• Conditions: Cirrhosis, Liver
• Intervention / Treatment: Other: App to monitor stool consistency and symptoms

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, 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.

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23249
      • Recruiting
      • Hunter Holmes McGuire VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

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
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
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

Collaborators and Investigators

• Sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2022
• Primary Completion (Anticipated): October 28, 2023
• Study Completion (Anticipated): October 28, 2023

Study Registration Dates

• First Submitted: October 28, 2022
• First Submitted That Met QC Criteria: October 28, 2022
• First Posted (Actual): November 3, 2022

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 27, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: BAJAJ033

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No