Cirrhosis, LiverNCT05604274
Longitudinal Monitoring of Stool Characteristics
An observational study of Cirrhosis, Liver, run by Hunter Holmes Mcguire Veteran Affairs Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cirrhosis, Liver
- What is being tested?
- App to monitor stool consistency and symptoms
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2022to 28 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- For cirrhosis subjects must meet all of the following inclusion criteria to be eligible:
- 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
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- 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
Who cannot join
- 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.
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- For healthy controls
- Any chronic disease requiring prescription medications
- Unfamiliar with smartphones
Trial locations and contacts
1 site in 1 country.
United States1 site
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249
About this study
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.
Read the 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.
- Conditions
- Cirrhosis, Liver
- Being tested
- App to monitor stool consistency and symptoms
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App to monitor stool consistency and symptomsOther
App to monitor stool consistency and symptoms
| Study group | Role | What they receive |
|---|---|---|
| Healthy controls | Not described Receives: Other: App to monitor stool consistency and symptoms | |
| Patients with cirrhosis on lactulose | Not described Receives: Other: App to monitor stool consistency and symptoms | |
| Patients with cirrhosis on rifaximin | Not described Receives: Other: App to monitor stool consistency and symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
App use comfort measured by survey
A survey designed to assess acceptability of this App at baseline and at 2 weeks; higher score=good
Measured: 2 weeks
Secondary outcomes (4)
Quality of life using Sickness Impact Profile
we will test association of the stool characteristics with quality of life; higher=good
Measured: 2 weeks
Cognitive testing using PHES
we will test association of the stool characteristics with PHES values; higher=good
Measured: 2 weeks
Alpha diversity using Shannon index of microbiome
we will test association of the stool characteristics with microbial characteristics
Measured: 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
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start28 Oct 2022
- Primary completion28 Oct 2023
- Study completion28 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cirrhosis, LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hunter Holmes Mcguire Veteran Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604274
- Sponsor's protocol ID
- BAJAJ033
- Status last verified
- Feb 2025
- First submitted
- 28 Oct 2022
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38153339
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Monitoring of Stool Characteristics
- ClinicalTrials.gov ID
- NCT05604274
- Acronym / sponsor ID
- BAJAJ033
- Conditions
- Cirrhosis, Liver
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hunter Holmes Mcguire Veteran Affairs Medical CenterUS federal agency
- Study start
- 28 Oct 2022 (actual)
- Primary completion
- 28 Oct 2023 (actual)
- Study completion
- 28 Oct 2023 (actual)
- First posted
- 3 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- For cirrhosis subjects must meet all of the following inclusion criteria to be eligible:
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| App to monitor stool consistency and symptomsApp to monitor stool consistency and symptoms | Other | Healthy controls, Patients with cirrhosis on lactulose, Patients with cirrhosis on rifaximin |
Primary outcome
App use comfort measured by survey
Time frame: 2 weeks
A survey designed to assess acceptability of this App at baseline and at 2 weeks; higher score=good
4 secondary outcomes
Quality of life using Sickness Impact Profile
Time frame: 2 weeks
Cognitive testing using PHES
Time frame: 2 weeks
Alpha diversity using Shannon index of microbiome
Time frame: 2 weeks
Bristol stool scale by subjects
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Derived from this study: PubMed 38153339Fagan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis, Liver, run by Hunter Holmes Mcguire Veteran Affairs Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
App use comfort measured by survey (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05604274, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.