Trial · NCT00811434
Study of Lactulose in Children With Chronic Liver Disease
NCT00811434, Phase 2, Terminated, Indiana University; results first posted 2014-02-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Lactulose in Children With Chronic Liver Disease. Trials, record NCT00811434. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00811434
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Lactulose in Children With Chronic Liver Disease
- NCT number
- NCT00811434
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 16 participants, actual
- Lead sponsor
- Indiana University
- Conditions
- Minimal Hepatic Encephalopathy
- Interventions
- Lactulose, placebo
- First posted
- 2008-12-19
- Last updated
- 2014-02-10
- Results first posted
- 2014-02-10
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of Minimal Hepatic Encephalopathy (MHE) in Children With Cirrhosis | baseline | failure of one cognitive function test indicates presence of MHE |
| Secondary | Health Related Quality of Life (HRQOL) | baseline | HRQOL administered to parents prior to treatment |
| Secondary | Effeccts of Lactulose Treatment on MHE as Measaured by Cognitive Function | before and after each treatment period | MHE as measured by failure of one or more cognitive test |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of Minimal Hepatic Encephalopathy (MHE) in Children With Cirrhosis | baseline | participant | NUMBER | |
| SECONDARY | Health Related Quality of Life (HRQOL) | baseline | data not collected as planned | ||
| SECONDARY | Effeccts of Lactulose Treatment on MHE as Measaured by Cognitive Function | before and after each treatment period | data not collected as planned |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence of Minimal Hepatic Encephalopathy (MHE) in Children With Cirrhosis | All Randomized Participants | 6 | participant |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention | STARTED | Lactulose First, Then Placebo | 7 | |
| First Intervention | STARTED | Placebo First, Then Lactulose | 5 | |
| First Intervention | COMPLETED | Lactulose First, Then Placebo | 4 | |
| First Intervention | COMPLETED | Placebo First, Then Lactulose | 5 | |
| First Intervention | NOT COMPLETED | Lactulose First, Then Placebo | 3 | |
| First Intervention | NOT COMPLETED | Placebo First, Then Lactulose | 0 | |
| Washout (1 Month) | STARTED | Lactulose First, Then Placebo | 4 | |
| Washout (1 Month) | STARTED | Placebo First, Then Lactulose | 5 | |
| Washout (1 Month) | COMPLETED | Lactulose First, Then Placebo | 4 | |
| Washout (1 Month) | COMPLETED | Placebo First, Then Lactulose | 5 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lactulose | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Lactulose | 0 | 12 |
| Total, other adverse events | Placebo | 0 | 9 |
| Total, serious adverse events | Lactulose | 0 | 12 |
| Total, serious adverse events | Placebo | 0 | 9 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Lactulose vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00811434
GET https://conductscience.org/api/trials/v1/NCT00811434/registered