Study of Lactulose in Children With Chronic Liver Disease (MHE)
This study has been completed.
Sponsor:
Indiana University
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT00811434
First received: December 18, 2008
Last updated: March 26, 2012
Last verified: March 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Minimal Hepatic Encephalopathy |
Drug: Lactulose Drug: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Improvement of Cognitive Function and Healthcare -Related Quality of Life After Lactulose Treatment in Children With Chronic Liver Disease |
Resource links provided by NLM:
MedlinePlus related topics:
Liver Diseases
Drug Information available for:
Lactulose
U.S. FDA Resources
Further study details as provided by Indiana University:
Primary Outcome Measures:
- Scores of cognitive/developmental testing will be altered following use of Lactulose therapy. [ Time Frame: three months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Lactulose treatment will show a change in serum ammonia levels. [ Time Frame: three months ] [ Designated as safety issue: No ]
| Enrollment: | 16 |
| Study Start Date: | January 2009 |
| Study Completion Date: | November 2010 |
| Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Lactulose
3 months of Lactulose therapy based on pt. weight
|
Drug: Lactulose
1.5cc/kg/day po for three months
|
|
Placebo Comparator: placebo
1.5 ml/kg day po of sugar water placebo for three months
|
Drug: placebo
1.5 ml sugar water/kg day for three months
|
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.
Eligibility| Ages Eligible for Study: | 5 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Clinical diagnosis of MHE as result of cognitive, developmental testing, pediatric pt. with cirrhosis as evidenced by imaging/biopsy
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00811434
Locations
| United States, Indiana | |
| James Whitcomb Riley Hospital for Children | |
| INdianapolis,, Indiana, United States, 46202 | |
Sponsors and Collaborators
Indiana University
Investigators
| Principal Investigator: | Girish Subbarao, M.D. | Indiana University |
More Information
No publications provided
| Responsible Party: | Indiana University |
| ClinicalTrials.gov Identifier: | NCT00811434 History of Changes |
| Other Study ID Numbers: | 0808-19, Clarian Grant VFR-279 |
| Study First Received: | December 18, 2008 |
| Last Updated: | March 26, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Indiana University:
|
encephalopathy pediatric liver disease pediatric cirrhosis serum ammonia levels |
Additional relevant MeSH terms:
|
Hepatic Encephalopathy Liver Diseases Brain Damage, Chronic Delirium Encephalitis Neurotoxicity Syndromes Liver Failure Hepatic Insufficiency Digestive System Diseases Brain Diseases, Metabolic Brain Diseases Central Nervous System Diseases Nervous System Diseases Metabolic Diseases Confusion |
Neurobehavioral Manifestations Neurologic Manifestations Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Central Nervous System Viral Diseases Virus Diseases Central Nervous System Infections Poisoning Substance-Related Disorders Lactulose Gastrointestinal Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013