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Prevention of Hepatic Encephalopathy With Mobile Application Based Lactulose Titration

Primary Purpose

Hepatic Encephalopathy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dieta mobile application
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hepatic Encephalopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mobile application-based Bristol stool scale

Arm Description

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

Outcomes

Primary Outcome Measures

Achievement of daily stool goal
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)

Secondary Outcome Measures

Full Information

First Posted
August 31, 2022
Last Updated
August 16, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05526404
Brief Title
Prevention of Hepatic Encephalopathy With Mobile Application Based Lactulose Titration
Official Title
Mobile Application Based Lactulose Titration for Prevention of Hepatic Encephalopathy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 14, 2022 (Actual)
Primary Completion Date
July 8, 2023 (Actual)
Study Completion Date
July 8, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Encephalopathy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mobile application-based Bristol stool scale
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Dieta mobile application
Intervention Description
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.
Primary Outcome Measure Information:
Title
Achievement of daily stool goal
Description
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)
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas Simonetto, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Prevention of Hepatic Encephalopathy With Mobile Application Based Lactulose Titration

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