Hepatic EncephalopathyNCT01113567
Effect of Lactose in Patients With Chronic Liver Disease and Minimal Hepatic Encephalopathy
A study testing Lactose-free milk and Whole milk in people with Hepatic Encephalopathy and Liver Cirrhosis, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatic Encephalopathy, Liver Cirrhosis
- What is being tested?
- Lactose-free milk and Whole milk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteMexico
- Study dates
- Jul 2010to 26 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of chronic liver disease of whichever etiology
- Minimal hepatic encephalopathy
- Lactose maldigestion
Who cannot join
- 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
Show all 9Show fewer
- Congestive heart failure
- Chronic Obstructive Pulmonary Disease
- Severe symptoms of lactose intolerance
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Mexicano del Seguro Social
Mexico City, Mexico City, 06725
About this study
Official title: Effect of Lactose in Patients With Chronic Liver Disease and Minimal Hepatic Encephalopathy. Double- Blind, Randomized, Controlled Clinical Trial
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.
Read the detailed description
Mortality due to chronic liver disease is among the first five causes of mortality related to digestive tract and liver diseases in patients on productive age. One of the most frequent complications of chronic liver insufficiency is minimal hepatic encephalopathy (MHE), which affects the quality of life and predisposes to the development of clinical hepatic encephalopathy. There are few evidences on the therapeutic alternatives for minimal hepatic encephalopathy. The administration of non-absorbable disaccharides has been proven to ameliorate MHE. Lactose maldigestion may justify the use of lactose in patients with chronic liver disease as a non-absorbable disaccharide for the treatment of MHE.
The aim of our study is to evaluate the efficacy of lactose administration in patients with minimal hepatic encephalopathy.
- Conditions
- Hepatic Encephalopathy, Liver Cirrhosis
- Being tested
- Lactose-free milk, Whole milk
- Keywords
- Hepatic Encephalopathy, Liver Cirrhosis, Disaccharides, Lactose, Quality of Life
- Medical subject headings
- Hepatic Encephalopathy, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lactose-free milkDietary supplement
3.5 g of lactose
Whole milkDietary supplement
Whole milk with 24 g lactose
| Study group | Role | What they receive |
|---|---|---|
| Diet and lactose-free milk | Placebo comparator | Lactose-free milk Receives: Dietary Supplement: Lactose-free milk |
| Diet and whole milk | Active comparator | Whole milk with lactose Receives: Dietary Supplement: Whole milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reversion of Minimal Hepatic Encephalopathy (MHE) in patients with cirrosis
Improve in Psychometric Hepatic Encephalopathy Score (PHES). The PHES includes five psychometric test: number connectiontests A and B; the digit symbol test; the line tracing test and the serial dotting test. To calculate th PHES, the validated equations for Mexican population will be used. Patients will be diagnosed with MHE when the PHES will be less than -4 points.
Measured: 30 days after intervention
Secondary outcomes (1)
Quality of life in patients with cirrhosis and minimal hepatic encephalopathy
Analyze the number of patients who improve the record of quality of life, that will be evaluated with the Chronic Liver Disease Questionnaire (CLDQ). The score of the six domains and the overall CLDQ was calculated with answers presented on a 7-point likert scale, where number 1 referred to the maximum frequency (always) and 7 to the lowest frequency (never). A change of 0.5 on the 1-7 scale aproximates the important difference in questionnaire score.
Measured: 30 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2010 (estimated)
- Study startJul 2010
- Primary completion26 Jul 2021
- Study completion26 Jul 2021
Why it stopped: erminated \[The study was withdrawn because of the reconversion of the hospital to care for patients with COVID19. For this reason, it was not possible to continue recruiting and monitoring patients for this clinical study.\]
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic EncephalopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Segundo Moran Villota, Coordinación de Investigación en Salud, Mexico
- Investigators
- Segundo Moran, MD, Principal investigator, Instituto Mexicano del Seguro Social
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01113567
- Sponsor's protocol ID
- 2010-785-016
- Status last verified
- Feb 2023
- First submitted
- 28 Apr 2010
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lactose in Patients With Chronic Liver Disease and Minimal Hepatic Encephalopathy. Double- Blind, Randomized, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT01113567
- Acronym / sponsor ID
- 2010-785-016
- Conditions
- Hepatic Encephalopathy, Liver Cirrhosis
- Keywords
- Hepatic Encephalopathy, Liver Cirrhosis, Disaccharides, Lactose, Quality of Life
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: erminated \[The study was withdrawn because of the reconversion of the hospital to care for patients with COVID19. For this reason, it was not possible to continue recruiting and monitoring patients for this clinical study.\]
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Study start
- Jul 2010 (actual)
- Primary completion
- 26 Jul 2021 (actual)
- Study completion
- 26 Jul 2021 (actual)
- First posted
- 30 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Mortality due to chronic liver disease is among the first five causes of mortality related to digestive tract and liver diseases in patients on productive age. One of the most frequent complications of chronic liver insufficiency is minimal hepatic encephalopathy (MHE), which affects the quality of life and predisposes to the development of clinical hepatic encephalopathy. There are few evidences on the therapeutic alternatives for minimal hepatic encephalopathy. The administration of non-absorbable disaccharides has been proven to ameliorate MHE. Lactose maldigestion may justify the use of lactose in patients with chronic liver disease as a non-absorbable disaccharide for the treatment of MHE.
The aim of our study is to evaluate the efficacy of lactose administration in patients with minimal hepatic encephalopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet and lactose-free milk | Placebo comparator | Dietary Supplement: Lactose-free milkLactose-free milk |
| Diet and whole milk | Active comparator | Dietary Supplement: Whole milkWhole milk with lactose |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of chronic liver disease of whichever etiology
- Minimal hepatic encephalopathy
- Lactose maldigestion
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lactose-free milk3.5 g of lactose | Dietary supplement | Diet and lactose-free milk |
| Whole milkWhole milk with 24 g lactose | Dietary supplement | Diet and whole milk |
Primary outcome
Reversion of Minimal Hepatic Encephalopathy (MHE) in patients with cirrosis
Time frame: 30 days after intervention
Improve in Psychometric Hepatic Encephalopathy Score (PHES). The PHES includes five psychometric test: number connectiontests A and B; the digit symbol test; the line tracing test and the serial dotting test. To calculate th PHES, the validated equations for Mexican population will be used. Patients will be diagnosed with MHE when the PHES will be less than -4 points.
1 secondary outcome
Quality of life in patients with cirrhosis and minimal hepatic encephalopathy
Time frame: 30 days after intervention
Results and safety
The study was stopped early (reason given: erminated \[The study was withdrawn because of the reconversion of the hospital to care for patients with COVID19. For this reason, it was not possible to continue recruiting and monitoring patients for this clinical study.\]). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Instituto Mexicano del Seguro SocialLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Segundo Moran, MD principal investigator
Instituto Mexicano del Seguro Social
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactose-free milk and Whole milk in people with Hepatic Encephalopathy and Liver Cirrhosis, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: erminated \[The study was withdrawn because of the reconversion of the hospital to care for patients with COVID19. For this reason, it was not possible to continue recruiting and monitoring patients for this clinical study.\]). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reversion of Minimal Hepatic Encephalopathy (MHE) in patients with cirrosis (time frame: 30 days after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2023; AzTrials last refreshed its copy on 8 Nov 2026.