Effect of Lactose in Patients With Chronic Liver Disease and Minimal Hepatic Encephalopathy (NCT01113567) | Clinical Trial Compass
TerminatedNot Applicable
Effect of Lactose in Patients With Chronic Liver Disease and Minimal Hepatic Encephalopathy
Stopped: erminated \[The study was withdrawn because of the reconversion of the hospital to care for patients with COVID19. For this reason, it was not possible to continue recruiting and monitoring patients for this clinical study.\]
Mexico18 participantsStarted 2010-07
Plain-language summary
Two groups of patients with minimal hepatic encephalopathy will be studied. The treatment group (n=17) will receive whole milk (24 g lactose) and the control group (n=17) will receive "lactose-free" milk (3.5 g of lactose) two times a day for 21 days. Clinical history, nutritional assessment, biochemical studies, psychometric tests, critical flicker frequency and a quality of life questionnaire will be performed. The patient will be assessed weekly 21 days. An external monitor will control the randomization process in order to allocate the patients into both study group and will not share the assignation codes with anyone until the end of the study.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of chronic liver disease of whichever etiology
* Minimal hepatic encephalopathy
* Lactose maldigestion
Exclusion Criteria:
* Patients with clinical manifestations of hepatic encephalopathy
* Recent use of antibiotics or psychotropic drugs
* Recent use of alcohol abuse
* Gastrointestinal bleeding
* Others neurological disorders that affect the psychometric test
* Chronic renal failure
* Congestive heart failure
* Chronic Obstructive Pulmonary Disease
* Severe symptoms of lactose intolerance
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reversion of Minimal Hepatic Encephalopathy (MHE) in patients with cirrosis
Timeframe: 30 days after intervention
Trial details
NCT IDNCT01113567
SponsorCoordinación de Investigación en Salud, Mexico