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NCT05526404 Clinical Trial

Prevention of Hepatic Encephalopathy With Mobile Application Based Lactulose Titration

Hepatic Encephalopathy Clinical Trial

Official title:
Mobile Application Based Lactulose Titration for Prevention of Hepatic Encephalopathy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05526404
Other study ID # 22-006646
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 14, 2022
Est. completion date July 8, 2023

Study information
Verified date August 2023
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date July 8, 2023
Est. primary completion date July 8, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Mayo Clinic Rochester Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
See also
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Withdrawn NCT02086825 - A Randomized Comparison of Rifaximin Versus Lactulose in Hospitalized Cirrhotic Patients With Renal Failure Phase 3
Completed NCT01446523 - S. Endotoxin, Inflammatory Mediators and MRS Before and After Treatment in MHE N/A
Completed NCT01218568 - Rifaximin Plus Lactulose Versus Lactulose Alone for the Treatment of Hepatic Encephalopathy: a Double Blind Randomized Trial N/A
Completed NCT01008293 - Effect of Probiotics in Treatment of Minimal Hepatic Encephalopathy (MHE) and Health Related Quality of Life Phase 2/Phase 3

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