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| ID | Type | Description | Link |
|---|---|---|---|
| Clarian Grant VFR-279 |
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funding period ended
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactulose | Active Comparator | 3 months of Lactulose therapy based on pt. weight |
|
| placebo | Placebo Comparator | 1.5 ml/kg day po of sugar water placebo for three months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactulose | Drug | 1.5cc/kg/day po for three months |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Minimal Hepatic Encephalopathy (MHE) in Children With Cirrhosis | failure of one cognitive function test indicates presence of MHE | baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Health Related Quality of Life (HRQOL) | HRQOL administered to parents prior to treatment | baseline |
| Effeccts of Lactulose Treatment on MHE as Measaured by Cognitive Function | MHE as measured by failure of one or more cognitive test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Girish Subbarao, M.D. | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James Whitcomb Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
Two subjects were withdrawn prior to randomization.Two did not meet entry criteria.
Informed consent was obtained on the first subject 1/16/2009 and recruitment continued until study closure in November 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Lactulose First, Then Placebo | Lactulose therapy based on weight; Washout; placebo therapy of 1.5ml/kg/day |
| FG001 | Placebo First, Then Lactulose | Placebo therapy of 1.5ml/kg/day; washout; lactulose therapy based on weight |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Washout (1 Month) |
| |||||||||||||
| Second Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | all aprticipants who were randomized to receive treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Minimal Hepatic Encephalopathy (MHE) in Children With Cirrhosis | failure of one cognitive function test indicates presence of MHE | Posted | Number | participant | baseline |
|
|
Total of 23 months
Assessed at both in person patient visits and phone call follow up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lactulose | 3 months of Lactulose therapy based on pt. weight |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Girish Subbarao | Riley Hospital | 317-944-3774 | gsrao@iupui.edu |
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| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| ID | Term |
|---|---|
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D007792 | Lactulose |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Drug |
1.5 ml sugar water/kg day for three months |
|
| before and after each treatment period |
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|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Secondary | Health Related Quality of Life (HRQOL) | HRQOL administered to parents prior to treatment | data not collected as planned | Posted | baseline |
|
|
| Secondary | Effeccts of Lactulose Treatment on MHE as Measaured by Cognitive Function | MHE as measured by failure of one or more cognitive test | data not collected as planned | Posted | before and after each treatment period |
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Placebo | 1.5 ml/kg day po of sugar water placebo for three months | 0 | 9 | 0 | 9 |
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| D000073893 |
| Sugars |