Minimal Hepatic EncephalopathyPhase 2MHENCT00811434
Study of Lactulose in Children With Chronic Liver Disease
A Phase 2 study testing Lactulose in people with Minimal Hepatic Encephalopathy, run by Indiana University at 1 site in United States.
Trial summary
Pediatric patients with chronic liver disease may have Minimal Hepatic Encephalopathy(MHE)which can cause changes in behavior,intelligence and neurological function.By utilizing cognitive and developmental testing we will determine if patients have MHE. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Minimal Hepatic Encephalopathy
- What is being tested?
- Lactulose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Nov 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Clinical diagnosis of MHE as result of cognitive, developmental testing, pediatric pt. with cirrhosis as evidenced by imaging/biopsy
Who cannot join
- patients with neurological,psychiatric or unstable medical conditions which may contribute to impaired cognitive function.
- patients with known hearing or vision difficulties.
- those patients who do not speak English will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
James Whitcomb Riley Hospital for Children
Indianapolis, Indiana, 46202
About this study
Official title: Improvement of Cognitive Function and Healthcare -Related Quality of Life After Lactulose Treatment in Children With Chronic Liver Disease
Pediatric patients with chronic liver disease may have Minimal Hepatic Encephalopathy(MHE)which can cause changes in behavior,intelligence and neurological function.By utilizing cognitive and developmental testing we will determine if patients have MHE. If so, we will trial 3 months of blinded placebo or Lactulose treatment followed by a washout period with no treatment. At this time patients are re-tested and then begin another three month period switching to the opposite treatment of first 3 months.Final cognitive/developmental testing will determine if Lactulose treatment has any effect on MHE.
Read the detailed description
In addition ,serum ammonia levels will be obtained at beginning of study,post-washout and at end of study to evaluate Lactulose effect on serum ammonia.
- Conditions
- Minimal Hepatic Encephalopathy
- Being tested
- Lactulose, placebo
- Keywords
- encephalopathy, pediatric liver disease, pediatric cirrhosis, serum ammonia levels
- Medical subject headings
- Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LactuloseDrug
1.5cc/kg/day po for three months
placeboDrug
1.5 ml sugar water/kg day for three months
| Study group | Role | What they receive |
|---|---|---|
| Lactulose | Active comparator | 3 months of Lactulose therapy based on pt. weight Receives: Drug: Lactulose |
| placebo | Placebo comparator | 1.5 ml/kg day po of sugar water placebo for three months Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Minimal Hepatic Encephalopathy (MHE) in Children With Cirrhosis
failure of one cognitive function test indicates presence of MHE
Measured: baseline
Secondary outcomes (2)
Health Related Quality of Life (HRQOL)
HRQOL administered to parents prior to treatment
Measured: baseline
Effeccts of Lactulose Treatment on MHE as Measaured by Cognitive Function
MHE as measured by failure of one or more cognitive test
Measured: before and after each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionNov 2010
- Study completionNov 2010
Why it stopped: funding period ended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Minimal Hepatic EncephalopathyStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Girish Subbarao, M.D., Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00811434
- Sponsor's protocol ID
- 0808-19
- Other IDs
- Clarian Grant VFR-279
- Acronym
- MHE
- Status last verified
- Feb 2014
- First submitted
- 18 Dec 2008
- Last updated
- 10 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improvement of Cognitive Function and Healthcare -Related Quality of Life After Lactulose Treatment in Children With Chronic Liver Disease
- ClinicalTrials.gov ID
- NCT00811434
- Acronym / sponsor ID
- MHE / 0808-19
- Conditions
- Minimal Hepatic Encephalopathy
- Keywords
- encephalopathy, pediatric liver disease, pediatric cirrhosis, serum ammonia levels
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: funding period ended
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 19 Dec 2008 (estimated)
- Results
- Posted 10 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pediatric patients with chronic liver disease may have Minimal Hepatic Encephalopathy(MHE)which can cause changes in behavior,intelligence and neurological function.By utilizing cognitive and developmental testing we will determine if patients have MHE. If so, we will trial 3 months of blinded placebo or Lactulose treatment followed by a washout period with no treatment. At this time patients are re-tested and then begin another three month period switching to the opposite treatment of first 3 months.Final cognitive/developmental testing will determine if Lactulose treatment has any effect on MHE.
Detailed description
In addition ,serum ammonia levels will be obtained at beginning of study,post-washout and at end of study to evaluate Lactulose effect on serum ammonia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lactulose | Active comparator | Drug: Lactulose3 months of Lactulose therapy based on pt. weight |
| placebo | Placebo comparator | Drug: placebo1.5 ml/kg day po of sugar water placebo for three months |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of MHE as result of cognitive, developmental testing, pediatric pt. with cirrhosis as evidenced by imaging/biopsy
Key exclusion criteria (3 listed)
- patients with neurological,psychiatric or unstable medical conditions which may contribute to impaired cognitive function.
- patients with known hearing or vision difficulties.
- those patients who do not speak English will be excluded.
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 |
|---|---|---|
| Lactulose1.5cc/kg/day po for three months | Drug | Lactulose |
| placebo1.5 ml sugar water/kg day for three months | Drug | placebo |
Primary outcome
Incidence of Minimal Hepatic Encephalopathy (MHE) in Children With Cirrhosis
Time frame: baseline
failure of one cognitive function test indicates presence of MHE
2 secondary outcomes
Health Related Quality of Life (HRQOL)
Time frame: baseline
Effeccts of Lactulose Treatment on MHE as Measaured by Cognitive Function
Time frame: before and after each treatment period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Electronic PHES vs Paper-based PHES for Hepatic Encephalopathy
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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.
Girish Subbarao, M.D. principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lactulose in people with Minimal Hepatic Encephalopathy, run by Indiana University at 1 site in United States.
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 1 inclusion and 3 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 10 Feb 2014. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of Minimal Hepatic Encephalopathy (MHE) in Children With Cirrhosis (time frame: baseline). 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 10 Feb 2014.