Trial · NCT01322386
Gastrointestinal Microbiota in Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin
NCT01322386, Phase 1, Completed, Stanford University; results first posted 2016-03-04
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Gastrointestinal Microbiota in Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin. Trials, record NCT01322386. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01322386
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Gastrointestinal Microbiota in Primary Sclerosing Cholangitis and Biliary Atresia With Vancomycin
- NCT number
- NCT01322386
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 32 participants, actual
- Lead sponsor
- Stanford University
- Conditions
- Primary Sclerosing Cholangitis, Biliary Atresia
- Interventions
- Vancomycin
- First posted
- 2011-03-24
- Last updated
- 2016-05-18
- Results first posted
- 2016-03-04
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Determine the Benefit of Oral Vancomycin Therapy for Primary Sclerosing Cholangitis and Biliary Atresia | Within 3 months of therapy | Determine the benefit of oral vancomycin therapy for Primary Sclerosing Cholangitis and Biliary Atresia through improvement of Liver function tests (LFTs) within 3 months of initiating therapy. In addition for PSC, we looked at 25% reduction of abnormal ALT \& GGT, reduction in biliary strictures and beading, and reduction of inflammation in liver biopsies and colon biopsies. |
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 | Determine the Benefit of Oral Vancomycin Therapy for Primary Sclerosing Cholangitis and Biliary Atresia | Within 3 months of therapy | Ten BA participants had surgery (Kasai portoenterostomyprocedure) at 1 week before starting the Vancomycin so we could not determine if they benefited from the therapy. On oral vancomycin, 9 PSC patients had improvement of LFTs, 8 had improvement of liver biopsies and/or MRI, and colon biopsies,and 1 pt. refused to have these additional studies. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Determine the Benefit of Oral Vancomycin Therapy for Primary Sclerosing Cholangitis and Biliary Atresia | Liver Blood Test | BA (n=10,0,0,0,0) | 10 | participants | |
| Determine the Benefit of Oral Vancomycin Therapy for Primary Sclerosing Cholangitis and Biliary Atresia | MRI / MRCP | BA (n=10,0,0,0,0) | 0 | participants | |
| Determine the Benefit of Oral Vancomycin Therapy for Primary Sclerosing Cholangitis and Biliary Atresia | Liver Biopsy | BA (n=10,0,0,0,0) | 0 | participants | |
| Determine the Benefit of Oral Vancomycin Therapy for Primary Sclerosing Cholangitis and Biliary Atresia | Colon Biopsies | BA (n=10,0,0,0,0) | 0 | participants | |
| Determine the Benefit of Oral Vancomycin Therapy for Primary Sclerosing Cholangitis and Biliary Atresia | Liver Biopsy and/or MRI | BA (n=10,0,0,0,0) | 0 | participants | |
| Determine the Benefit of Oral Vancomycin Therapy for Primary Sclerosing Cholangitis and Biliary Atresia | Liver Blood Test | PSC (n=9,7,4,8,8) | 9 | participants | |
| Determine the Benefit of Oral Vancomycin Therapy for Primary Sclerosing Cholangitis and Biliary Atresia | MRI / MRCP | PSC (n=9,7,4,8,8) | 7 | participants | |
| Determine the Benefit of Oral Vancomycin Therapy for Primary Sclerosing Cholangitis and Biliary Atresia | Liver Biopsy | PSC (n=9,7,4,8,8) | 4 | participants | |
| Determine the Benefit of Oral Vancomycin Therapy for Primary Sclerosing Cholangitis and Biliary Atresia | Colon Biopsies | PSC (n=9,7,4,8,8) | 8 | participants | |
| Determine the Benefit of Oral Vancomycin Therapy for Primary Sclerosing Cholangitis and Biliary Atresia | Liver Biopsy and/or MRI | PSC (n=9,7,4,8,8) | 8 | participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Oral Vancomycin-Biliary Atresia | 10 | |
| Overall Study | STARTED | Oral Vancomycin/ Primary Sclerosing Cholangitis | 11 | |
| Overall Study | COMPLETED | Oral Vancomycin-Biliary Atresia | 10 | |
| Overall Study | COMPLETED | Oral Vancomycin/ Primary Sclerosing Cholangitis | 9 | |
| Overall Study | NOT COMPLETED | Oral Vancomycin-Biliary Atresia | 0 | |
| Overall Study | NOT COMPLETED | Oral Vancomycin/ Primary Sclerosing Cholangitis | 2 |
Source ClinicalTrials.gov
Adverse events1
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 | Non-malignant Spinal Cord Tumor | Nervous system disorders | BA/PSC -Oral Vancomycin | 1 | 21 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | BA/PSC -Oral Vancomycin | ||
| Total, other adverse events | BA/PSC -Oral Vancomycin | 0 | 21 |
| Total, serious adverse events | BA/PSC -Oral Vancomycin | 1 | 21 |
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/NCT01322386
GET https://conductscience.org/api/trials/v1/NCT01322386/registered