Longitudinal Monitoring of Stool Characteristics

NCT05604274 | Completed

• 1 other identifier: BAJAJ033
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Cirrhosis, Liver

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Quality of life using Sickness Impact Profile

  2 weeks

• Cognitive testing using PHES

  2 weeks

• Alpha diversity using Shannon index of microbiome

  2 weeks

• Bristol stool scale by subjects

  2 weeks

Study Arms (3)

Healthy controls

Other: App to monitor stool consistency and symptoms

Patients with cirrhosis on lactulose

Other: App to monitor stool consistency and symptoms

Patients with cirrhosis on rifaximin

Other: App to monitor stool consistency and symptoms

Interventions

App to monitor stool consistency and symptoms OTHER

App to monitor stool consistency and symptoms

Healthy controls; Patients with cirrhosis on lactulose; Patients with cirrhosis on rifaximin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Male and female subjects aged ≥ 18 years.
• Cirrhosis
• 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 controls :
• Male and female subjects aged ≥ 18 years.
• 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

You may not qualify if:

• Subjects with cirrhosis meeting any of the following criteria are not eligible for study enrollment:
• Unclear diagnosis of cirrhosis
• History of liver transplant
• For those on lactulose, they need to be on it for at least 2 weeks
• Unfamiliar with smartphones
• 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

Sponsors & Collaborators

• Hunter Holmes Mcguire Veteran Affairs Medical Center: lead

Study Sites (1)

Hunter Holmes McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Location

Related Publications (1)

• 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.

  PMID: 38153339 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Microbiome analysis

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 3, 2022
• Study Start: October 28, 2022
• Primary Completion: October 28, 2023
• Study Completion: October 28, 2023
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)