Clinical trial NCT05604274: Longitudinal Monitoring of Stool Characteristics
Official title: Longitudinal Monitoring of Stool Characteristics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cirrhosis, Liver
Lead sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center
Sponsor class: FED
First posted: 2022-11-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: App use comfort measured by survey
timeFrame: 2 weeks
Secondary outcomes:
measure: Quality of life using Sickness Impact Profile
timeFrame: 2 weeks
measure: Cognitive testing using PHES
timeFrame: 2 weeks
measure: Alpha diversity using Shannon index of microbiome
timeFrame: 2 weeks
measure: Bristol stool scale by subjects
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Hunter Holmes McGuire VA Medical Center
state: Virginia
Study officials:
References: