Trial · NCT03617445
Fecal Microbiota Transplantation for C. Difficile Infection in Solid Organ Transplant Recipients
NCT03617445, Phase 2, Terminated, University of Wisconsin, Madison; results first posted 2025-01-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Fecal Microbiota Transplantation for C. Difficile Infection in Solid Organ Transplant Recipients. Trials, record NCT03617445. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03617445
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fecal Microbiota Transplantation for C. Difficile Infection in Solid Organ Transplant Recipients
- NCT number
- NCT03617445
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 3 participants, actual
- Lead sponsor
- University of Wisconsin, Madison
- Conditions
- Clostridium Difficile Infection Recurrence
- Interventions
- FMT oral capsule, Oral Vancomycin, FMT oral placebo, Oral Vancomycin placebo
- First posted
- 2018-08-06
- Last updated
- 2025-01-09
- Results first posted
- 2025-01-09
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Compare the Rate of Recurrence of CDI in Solid Organ Transplant Recipients With FMT Compared With Oral Vancomycin | 60 consecutive days | Recurrence is defined as diarrhea (greater or equal to 3 or more loose stools that take the shape of the collection container in a 24 hr period) |
| Secondary | CDI-related Quality of Life (QOL) Compared Using Treatment and Time Interaction as Model Terms While Adjusting for Potential Confounders | Weeks 4, 29 weeks | Cdiff32 32-item questionnaire, with a range of 0 to 100, with 100 representing the best score, and 0 representing the worst score. Dietary component of the questionnaire linked to any stool microbiome data to determine whether diet influences gut microbiota. |
| Secondary | Compare the Change in Gut Microbiota and Evaluate Changes in Microbiota to Assess for Safety of FMT in Patients | up to 30 weeks of study participation | Using multiple metric of microbiota structure and function, analyze gut microbiome samples to evaluate the association between change in gut microbiome and recurrent CDI |
| Secondary | Number of Patients Who Experienced Short or Medium Term Adverse Events | Up 30 weeks of study participation | List and evaluate all short- and medium-term safety events as defined in the study protocol for the safety of FMT in SOT patients |
| Secondary | Compare the Effects of FMT and Oral Vancomycin on Intestinal Colonization by Multi-drug-resistant Organisms Other Than C. Difficile in SOT Patients | up to 30 weeks of study participation | Analysis all stool samples and compare the effects of FMT and oral vancomycin on intestinal colonization with multi-drug resistant organisms (other than C. difficile) in SOT patients |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Compare the Rate of Recurrence of CDI in Solid Organ Transplant Recipients With FMT Compared With Oral Vancomycin | 60 consecutive days | Target enrollment was not met and data cannot be compared as all enrolled subjects were randomized to 1 arm only. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | CDI-related Quality of Life (QOL) Compared Using Treatment and Time Interaction as Model Terms While Adjusting for Potential Confounders | Weeks 4, 29 weeks | Study ended early per FDA-related COVID restrictions, samples not processed. No data available to report. | ||
| SECONDARY | Compare the Change in Gut Microbiota and Evaluate Changes in Microbiota to Assess for Safety of FMT in Patients | up to 30 weeks of study participation | Study ended early per FDA-related COVID restrictions, samples not processed. No data available to report. | ||
| SECONDARY | Number of Patients Who Experienced Short or Medium Term Adverse Events | Up 30 weeks of study participation | Target enrollment was not reached and all subjects were randomized to 1 arm only, so planned analyses cannot be performed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Compare the Effects of FMT and Oral Vancomycin on Intestinal Colonization by Multi-drug-resistant Organisms Other Than C. Difficile in SOT Patients | up to 30 weeks of study participation | Study ended early per FDA-related COVID restrictions, samples not processed. No data available to report. |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Compare the Rate of Recurrence of CDI in Solid Organ Transplant Recipients With FMT Compared With Oral Vancomycin | FMT Oral Capsules/ Oral Vancomycin Placebo | 0 | Participants | ||
| Compare the Rate of Recurrence of CDI in Solid Organ Transplant Recipients With FMT Compared With Oral Vancomycin | Placebo FMT Capsules/ Active Oral Vancomycin | 1 | Participants | ||
| Number of Patients Who Experienced Short or Medium Term Adverse Events | FMT Oral Capsules/ Oral Vancomycin Placebo | 0 | Participants | ||
| Number of Patients Who Experienced Short or Medium Term Adverse Events | Placebo FMT Capsules/ Active Oral Vancomycin | 1 | 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 | FMT Oral Capsules/ Oral Vancomycin Placebo | 0 | |
| Overall Study | STARTED | Placebo FMT Capsules/ Active Oral Vancomycin | 3 | |
| Overall Study | COMPLETED | FMT Oral Capsules/ Oral Vancomycin Placebo | 0 | |
| Overall Study | COMPLETED | Placebo FMT Capsules/ Active Oral Vancomycin | 3 | |
| Overall Study | NOT COMPLETED | FMT Oral Capsules/ Oral Vancomycin Placebo | 0 | |
| Overall Study | NOT COMPLETED | Placebo FMT Capsules/ Active Oral Vancomycin | 0 |
Source ClinicalTrials.gov
Adverse events2
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 | Hospitalization due to toe infection | Metabolism and nutrition disorders | FMT Oral Capsules/ Oral Vancomycin Placebo | 0 | 0 | 0 |
| serious | Hospitalization due to toe infection | Metabolism and nutrition disorders | Placebo FMT Capsules/ Active Oral Vancomycin | 1 | 3 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | FMT Oral Capsules/ Oral Vancomycin Placebo | 0 | 0 |
| Total, all-cause mortality | Placebo FMT Capsules/ Active Oral Vancomycin | 0 | 3 |
| Total, other adverse events | FMT Oral Capsules/ Oral Vancomycin Placebo | 0 | 0 |
| Total, other adverse events | Placebo FMT Capsules/ Active Oral Vancomycin | 0 | 3 |
| Total, serious adverse events | FMT Oral Capsules/ Oral Vancomycin Placebo | 0 | 0 |
| Total, serious adverse events | Placebo FMT Capsules/ Active Oral Vancomycin | 1 | 3 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01AI125053 | Fecal Microbiota Transplant for C. difficile Infection in Solid Organ Transplant Recipients | SAFDAR, NASIA | UNIVERSITY OF WISCONSIN-MADISON | NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES | 2018 to 2022 |
Source NIH RePORTER
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/NCT03617445
GET https://conductscience.org/api/trials/v1/NCT03617445/registered