Trial · NCT01346059
Intracolonic Vancomycin Therapy in Severe C. Diff Colitis
NCT01346059, Not applicable, Terminated, Corewell Health East; results first posted 2017-03-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Intracolonic Vancomycin Therapy in Severe C. Diff Colitis. Trials, record NCT01346059. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01346059
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Intracolonic Vancomycin Therapy in Severe C. Diff Colitis
- NCT number
- NCT01346059
- Status
- Terminated
- Phases
- Not applicable
- Enrollment
- 2 participants, actual
- Lead sponsor
- Corewell Health East
- Conditions
- Colitis
- Interventions
- Vancomycin, Saline
- First posted
- 2011-05-02
- Last updated
- 2017-03-29
- Results first posted
- 2017-03-29
- Limitations and caveats
- Early termination leading to small numbers of subjects analyzed. Technical problems with catheters becoming dislodged from the ideal site of placement (cecum) leading to unreliable data.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Resolution of Diarrhea and White Blood Cell Count Elevation | 14 days | If the patient has resolution of diarrhea, white blood cell count, and abdominal pain, the protocol will be stopped. |
| Secondary | Mortality | 30 day | Death within 30 days of enrollment, in or out of hospital |
| Secondary | Need for Colectomy | 30 day | Partial or complete colectomy performed within 30 days of enrollment |
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 | Resolution of Diarrhea and White Blood Cell Count Elevation | 14 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Mortality | 30 day | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Need for Colectomy | 30 day | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Resolution of Diarrhea and White Blood Cell Count Elevation | Vancomycin | 1 | Participants | ||
| Mortality | Vancomycin | 0 | Participants | ||
| Need for Colectomy | Vancomycin | 0 | 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 | Saline | 1 | |
| Overall Study | STARTED | Vancomycin | 1 | |
| Overall Study | COMPLETED | Saline | 0 | |
| Overall Study | COMPLETED | Vancomycin | 1 | |
| Overall Study | NOT COMPLETED | Saline | 1 | |
| Overall Study | NOT COMPLETED | Vancomycin | 0 |
Source ClinicalTrials.gov
Adverse 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 | Saline | 0 | 1 |
| Total, all-cause mortality | Vancomycin | 0 | 1 |
| Total, other adverse events | Saline | 0 | 1 |
| Total, other adverse events | Vancomycin | 0 | 1 |
| Total, serious adverse events | Saline | 0 | 1 |
| Total, serious adverse events | Vancomycin | 0 | 1 |
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Saline vs Vancomycin: deaths from any cause | Trial comparisons |
| Saline vs Vancomycin: serious adverse events | 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/NCT01346059
GET https://conductscience.org/api/trials/v1/NCT01346059/registered