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Prevention of Hepatic Encephalopathy With Mobile Application Based Lactulose Titration

Mobile Application Based Lactulose Titration for Prevention of Hepatic Encephalopathy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05526404
Enrollment
50
Registered
2022-09-02
Start date
2022-09-14
Completion date
2023-07-08
Last updated
2023-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Encephalopathy

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.

Interventions

OTHERDieta 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.

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Achievement of daily stool goal4 weeksNumber 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)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026