Hepatic Encephalopathy Management Via Smartphone Application-Enabled Stool Monitoring
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 23-009055
About this study
The purspoe of this study is to determine whether a smartphone-enabled application with stool imaging technology allows patients with decompensated cirrhosis and hepatic encephalopathy on lactulose, to achieve and maintain the recommended number of daily BMs and Bristol stool type more often than they would otherwise, thereby helping them more effectively prevent HE and reduce healthcare utilization.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Patients ±18 years of age.
- Ability to provide written, informed consent.
- Confirmed decompensated cirrhosis of any etiology.
- Currently taking lactulose daily for management of hepatic encephalopathy.
- Participant has a smartphone device with access to internet connection.
Exclusion Criteria:
- Recent change in dosing of opioid medication (within 30 days of consenting).
- Inflammatory Bowel Disease or presence of intestinal obstruction.
- Previous Colorectal Surgery.
- Active diarrheal illness.
- Lack of smartphone or other smart device at home.
- Presence of overt HE at the time of enrollment.
- Lactulose intolerance.
- History of cognitive impairment.
Note: Other protocol defined Inclusion/Exclusion Criteria may apply.
Eligibility last updated 9/13/23. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Douglas Simonetto, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available