Prevention of Hepatic Encephalopathy With Mobile Application Based Lactulose Titration

NCT ID: NCT05526404

Last Updated: 2023-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-14

Study Completion Date

2023-07-08

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatic Encephalopathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Mobile application-based Bristol stool scale

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

Group Type EXPERIMENTAL

Dieta mobile application

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Douglas (Doug) A. Simonetto

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Douglas Simonetto, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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22-006646

Identifier Type: -

Identifier Source: org_study_id

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