Trial · NCT00858858
Clinical Studies on Bile Acids in Barrett's Esophagus
NCT00858858, Not applicable, Completed, US Department of Veterans Affairs; results first posted 2014-11-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Studies on Bile Acids in Barrett's Esophagus. Trials, record NCT00858858. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00858858
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Studies on Bile Acids in Barrett's Esophagus
- NCT number
- NCT00858858
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 60 participants, actual
- Lead sponsor
- US Department of Veterans Affairs
- Conditions
- Gastroesophageal Reflux Disease
- Interventions
- Ursodeoxycholic Acid
- First posted
- 2009-03-10
- Last updated
- 2015-04-30
- Results first posted
- 2014-11-24
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Protection Against DNA Damage by UDCA | After 8 weeks of UDCA treatment | p-H2AX levels are a measure of DNA damage. Our major outcome measure is the change in p-H2AX levels, expressed as relative densitometry units, after DCA perfusion in patients treated with oral UDCA. If UDCA protects against bile acid-induced DNA damage, then p-H2AX levels before and after perfusion should not change significantly. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Protection Against DNA Damage by UDCA | After 8 weeks of UDCA treatment | Patients with Barrett's esophagus, only metaplastic epithelium evaluated. No data were collected from squamous epithelium as originally planned because our in vitro studies subsequently showed that DCA exposure did not cause DNA damage in squamous cells and, therefore, oral UDCA treatment would be meaningless for squamous esophagus. | Relative Densitometry Units | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Protection Against DNA Damage by UDCA | Arm 1 | Before DCA Perfusion | 1.068 | Standard Error .17 | Relative Densitometry Units |
| Protection Against DNA Damage by UDCA | Arm 1 | After DCA Perfusion | .82 | Standard Error .14 | Relative Densitometry Units |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm 1 | 60 | |
| Overall Study | COMPLETED | Arm 1 | 42 | |
| Overall Study | NOT COMPLETED | Arm 1 | 18 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Ruptured cerebral aneurysm | Vascular disorders | Arm 1 | 1 | 42 | 1 |
| serious | Ischemic colitis | Gastrointestinal disorders | Arm 1 | 1 | 42 | 1 |
| serious | Death | Cardiac disorders | Arm 1 | 1 | 42 | 1 |
| serious | Abdominal pain | Gastrointestinal disorders | Arm 1 | 1 | 42 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm 1 | ||
| Total, other adverse events | Arm 1 | 0 | 42 |
| Total, serious adverse events | Arm 1 | 4 | 42 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00858858
GET https://conductscience.org/api/trials/v1/NCT00858858/registered