Trial · NCT01085760
A Pilot Study of Vancomycin or Metronidazole in Patients With Primary Sclerosing Cholangitis
NCT01085760, Phase 1, Completed, Mayo Clinic; results first posted 2013-09-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Pilot Study of Vancomycin or Metronidazole in Patients With Primary Sclerosing Cholangitis. Trials, record NCT01085760. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01085760
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Pilot Study of Vancomycin or Metronidazole in Patients With Primary Sclerosing Cholangitis
- NCT number
- NCT01085760
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 35 participants, actual
- Lead sponsor
- Mayo Clinic
- Conditions
- Primary Sclerosing Cholangitis
- Interventions
- Vancomycin, Vancomycin, Metronidazole, Metronidazole, Vancomycin
- First posted
- 2010-03-12
- Last updated
- 2013-09-19
- Results first posted
- 2013-09-19
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Alkaline Phosphatase Following 12 Weeks of Treatment | baseline, 12 weeks | |
| Secondary | Change From Baseline in Total Bilirubin Following 12 Weeks Treatment | baseline, 12 weeks | |
| Secondary | Change From Baseline in Mayo PSC Risk Score Following 12 Weeks of Treatment | baseline, 12 weeks | The Mayo PSC risk score was calculated for each patient at baseline and at 12 weeks, where Risk = 0.03 (age \[years\]) + 0.54 Ln (total bilirubin \[mg/dL\]) + 0.54 Ln (AST \[IU/L\]) + 1.24 (variceal bleeding) - 0.84 (albumin \[g/dL\]). There is no range, minimum, or maximum value but greater values indicate worse disease. |
| Secondary | Change From Baseline in C-Reactive Protein Following 12 Weeks of Treatment | baseline, 12 weeks |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Alkaline Phosphatase Following 12 Weeks of Treatment | baseline, 12 weeks | The number of participants was based on a per protocol analysis. | U/L | MEDIAN |
| SECONDARY | Change From Baseline in Total Bilirubin Following 12 Weeks Treatment | baseline, 12 weeks | Per protocol analysis done | mg/dl | MEDIAN |
| SECONDARY | Change From Baseline in Mayo PSC Risk Score Following 12 Weeks of Treatment | baseline, 12 weeks | Per protocol analysis | units on a scale | MEDIAN |
| SECONDARY | Change From Baseline in C-Reactive Protein Following 12 Weeks of Treatment | baseline, 12 weeks | Per protocol analysis done | mg/L | MEDIAN |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Alkaline Phosphatase Following 12 Weeks of Treatment | Low Dose Vancomycin | -117 | Full Range -304 to 165 | U/L | |
| Change From Baseline in Alkaline Phosphatase Following 12 Weeks of Treatment | High Dose Vancomycin | -49 | Full Range -315 to 18 | U/L | |
| Change From Baseline in Alkaline Phosphatase Following 12 Weeks of Treatment | Low Dose Metronidazole | -62 | Full Range -502 to 212 | U/L | |
| Change From Baseline in Alkaline Phosphatase Following 12 Weeks of Treatment | High Dose Metronidazole | -36 | Full Range -450 to 42 | U/L | |
| Change From Baseline in Total Bilirubin Following 12 Weeks Treatment | Low Dose Vancomycin | -0.4 | Full Range -0.9 to 0.2 | mg/dl | |
| Change From Baseline in Total Bilirubin Following 12 Weeks Treatment | High Dose Vancomycin | 0.05 | Full Range -0.8 to 9.7 | mg/dl | |
| Change From Baseline in Total Bilirubin Following 12 Weeks Treatment | Low Dose Metronidazole | -0.3 | Full Range -0.5 to 0 | mg/dl | |
| Change From Baseline in Total Bilirubin Following 12 Weeks Treatment | High Dose Metronidazole | 0.05 | Full Range -0.5 to 0.4 | mg/dl | |
| Change From Baseline in Mayo PSC Risk Score Following 12 Weeks of Treatment | Low Dose Vancomycin | -0.65 | Full Range -1.13 to 0.21 | units on a scale | |
| Change From Baseline in Mayo PSC Risk Score Following 12 Weeks of Treatment | High Dose Vancomycin | -0.01 | Full Range -0.71 to 1.15 | units on a scale |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Low Dose Vancomycin | 8 | |
| Overall Study | STARTED | High Dose Vancomycin | 9 | |
| Overall Study | STARTED | Low Dose Metronidazole | 9 | |
| Overall Study | STARTED | High Dose Metronidazole | 9 | |
| Overall Study | COMPLETED | Low Dose Vancomycin | 7 | |
| Overall Study | COMPLETED | High Dose Vancomycin | 8 | |
| Overall Study | COMPLETED | Low Dose Metronidazole | 7 | |
| Overall Study | COMPLETED | High Dose Metronidazole | 6 | |
| Overall Study | NOT COMPLETED | Low Dose Vancomycin | 1 | |
| Overall Study | NOT COMPLETED | High Dose Vancomycin | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events60
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 |
|---|---|---|---|---|---|---|
| other | diarrhea | Gastrointestinal disorders | Low Dose Vancomycin | 1 | 8 | 1 |
| other | diarrhea | Gastrointestinal disorders | High Dose Vancomycin | 1 | 9 | 1 |
| other | diarrhea | Gastrointestinal disorders | Low Dose Metronidazole | 0 | 9 | 0 |
| other | diarrhea | Gastrointestinal disorders | High Dose Metronidazole | 1 | 9 | 1 |
| other | nausea | Gastrointestinal disorders | Low Dose Vancomycin | 0 | 8 | 0 |
| other | nausea | Gastrointestinal disorders | High Dose Vancomycin | 1 | 9 | 1 |
| other | nausea | Gastrointestinal disorders | Low Dose Metronidazole | 1 | 9 | 1 |
| other | nausea | Gastrointestinal disorders | High Dose Metronidazole | 6 | 9 | 6 |
| other | anorexia | Gastrointestinal disorders | Low Dose Vancomycin | 0 | 8 | 0 |
| other | anorexia | Gastrointestinal disorders | High Dose Vancomycin | 0 | 9 | 0 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Low Dose Vancomycin | ||
| Total, all-cause mortality | High Dose Vancomycin | ||
| Total, all-cause mortality | Low Dose Metronidazole | ||
| Total, all-cause mortality | High Dose Metronidazole | ||
| Total, other adverse events | Low Dose Vancomycin | 4 | 8 |
| Total, other adverse events | High Dose Vancomycin | 3 | 9 |
| Total, other adverse events | Low Dose Metronidazole | 6 | 9 |
| Total, other adverse events | High Dose Metronidazole | 8 | 9 |
| Total, serious adverse events | Low Dose Vancomycin | 0 | 8 |
| Total, serious adverse events | High Dose Vancomycin | 0 | 9 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23384404 | DERIVED |
Source PubMed
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/NCT01085760
GET https://conductscience.org/api/trials/v1/NCT01085760/events?page=2