Prevention of Hepatic Encephalopathy With Mobile Application Based Lactulose Titration

NCT05526404 | Completed

• 1 other identifier: 22-006646
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatic Encephalopathy

Outcome Measures

Primary Outcomes (1)

• 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)

  4 weeks

Study Arms (1)

Mobile application-based Bristol stool scale

EXPERIMENTAL

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

Interventions

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.

Mobile application-based Bristol stool scale

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Hepatic Encephalopathy

Condition Hierarchy (Ancestors)

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

Study Officials

• Douglas Simonetto, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 31, 2022
• First Posted: September 2, 2022
• Study Start: September 14, 2022
• Primary Completion: July 8, 2023
• Study Completion: July 8, 2023
• Last Updated: August 18, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)