Prevention of Hepatic Encephalopathy With Mobile Application Based Lactulose Titration

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.

Completed

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Key information

Conditions

Hepatic Encephalopathy Brain Diseases Brain Diseases, Metabolic Central Nervous System Diseases Digestive System Diseases Hepatic Insufficiency Liver Diseases Liver Failure Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dieta mobile application

Other

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 outcomes

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)

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Mobile Application Based Lactulose Titration for Prevention of Hepatic Encephalopathy

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Sep 2, 2022
Registry last updated: Aug 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed