Prevention of Hepatic Encephalopathy With Mobile Application Based Lactulose Titration

August 16, 2023 updated by: Douglas (Doug) A. Simonetto, Mayo Clinic

Mobile Application Based Lactulose Titration for Prevention of Hepatic Encephalopathy

This study is being done to assess the safety and efficacy of using mobile application-based Bristol stool scale to titrate lactulose in prevention episodes of hepatic encephalopathy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Ability to provide written, informed consent.
  • Currently taking lactulose daily for prevention of hepatic encephalopathy.

Exclusion Criteria:

  • Recent change in dosing of opioid medication.
  • Previous Colorectal Surgery.
  • Active diarrheal illness.
  • Lack of smartphone or other smart device at home.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mobile application-based Bristol stool scale
Subjects with cirrhosis who are taking lactulose for the treatment of hepatic encephalopathy will download the Dieta mobile application on their mobile device and take a photo of each bowel movement using the Dieta application
Other: Dieta mobile application
Mobile application that functions on mobile phones and allows for tracking of symptoms, dietary intake, and stool characteristics using logs and pictures. Users of the application track symptoms by completing questionnaires regarding stool frequency, consistency, and mental status changes. Users can track dietary intake and stool characteristics by taking time-stamped photos of all dietary intake and bowel movements.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Achievement of daily stool goal
Time Frame: 4 weeks
Number of subject to achieve daily stool goal, determined if use of the mobile application leads to improved rates of meeting daily stool goal (3-4 stools per day of Bristol Stool Scale 3-4)
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Douglas Simonetto, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2022

Primary Completion (Actual)

July 8, 2023

Study Completion (Actual)

July 8, 2023

Study Registration Dates

First Submitted

August 31, 2022

First Submitted That Met QC Criteria

August 31, 2022

First Posted (Actual)

September 2, 2022

Study Record Updates

Last Update Posted (Actual)

August 18, 2023

Last Update Submitted That Met QC Criteria

August 16, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-006646

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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