Trial · NCT03760484
Fecal Microbiota Transplant (FMT) Plus Fidaxomicin for Severe or Fulminant Clostridium Difficile Infection
NCT03760484, Phase 2, Terminated, University of Alberta; results first posted 2022-12-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Fecal Microbiota Transplant (FMT) Plus Fidaxomicin for Severe or Fulminant Clostridium Difficile Infection. Trials, record NCT03760484. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03760484
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fecal Microbiota Transplant (FMT) Plus Fidaxomicin for Severe or Fulminant Clostridium Difficile Infection
- NCT number
- NCT03760484
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 4 participants, actual
- Lead sponsor
- University of Alberta
- Conditions
- Clostridium Difficile
- Interventions
- Fidaxomicin 200 mg, fecal microbiota transplantation (FMT)
- First posted
- 2018-11-30
- Last updated
- 2022-12-13
- Results first posted
- 2022-12-13
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | C Difficile Infection (CDI) Resolution- Short Term (Two Weeks After Final Fecal Microbiota Transplant (FMT)) | 2 weeks after final Fecal Microbiota Transplant (FMT) | Defined as \<3 unformed bowel movements/24h or return to baseline bowel habit 2 weeks after final Fecal Microbiota Transplant (FMT) |
| Secondary | Sustained C Difficile Infection (CDI) Resolution (Eight Weeks After Final After Final Fecal Microbiota Transplant (FMT)) | 8 weeks after final Fecal Microbiota Transplant (FMT) | Sustained C difficile infection (CDI) resolution defined as lack of C difficile infection (CDI) recurrence 8 weeks after final Fecal Microbiota Transplant (FMT) |
| Secondary | Death | 8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days | Reported death |
| Secondary | Perforation | 8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days | Colonic perforation |
| Secondary | Infection | 8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days. | Proven infection related final Fecal Microbiota Transplant (FMT) |
| Secondary | Hospitalization | 8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days. | Hospitalization due to C. difficile infection (CDI) |
| Secondary | Colectomy | 8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days. | Surgical Intervention - Colectomy |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | C Difficile Infection (CDI) Resolution- Short Term (Two Weeks After Final Fecal Microbiota Transplant (FMT)) | 2 weeks after final Fecal Microbiota Transplant (FMT) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Sustained C Difficile Infection (CDI) Resolution (Eight Weeks After Final After Final Fecal Microbiota Transplant (FMT)) | 8 weeks after final Fecal Microbiota Transplant (FMT) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Death | 8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Perforation | 8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Infection | 8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Hospitalization | 8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Colectomy | 8 weeks after final Fecal Microbiota Transplant (FMT); up to 96 days. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| C Difficile Infection (CDI) Resolution- Short Term (Two Weeks After Final Fecal Microbiota Transplant (FMT)) | Fecal Transplant With Fidaxomicin | 4 | Participants | ||
| Sustained C Difficile Infection (CDI) Resolution (Eight Weeks After Final After Final Fecal Microbiota Transplant (FMT)) | Fecal Transplant With Fidaxomicin | 3 | Participants | ||
| Death | Fecal Transplant With Fidaxomicin | 0 | Participants | ||
| Perforation | Fecal Transplant With Fidaxomicin | 0 | Participants | ||
| Infection | Fecal Transplant With Fidaxomicin | 0 | Participants | ||
| Hospitalization | Fecal Transplant With Fidaxomicin | 0 | Participants | ||
| Colectomy | Fecal Transplant With Fidaxomicin | 0 | Participants |
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 | Fecal Transplant With Fidaxomicin | 4 | |
| Overall Study | COMPLETED | Fecal Transplant With Fidaxomicin | 4 | |
| Overall Study | NOT COMPLETED | Fecal Transplant With Fidaxomicin | 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 totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Fecal Transplant With Fidaxomicin | 0 | 4 |
| Total, other adverse events | Fecal Transplant With Fidaxomicin | 0 | 4 |
| Total, serious adverse events | Fecal Transplant With Fidaxomicin | 0 | 4 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34831456 | BACKGROUND |
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/NCT03760484
GET https://conductscience.org/api/trials/v1/NCT03760484/registered