Trial Outcomes & Findings for Fecal Microbiota Transplantation (FMT) for MDRO UTI (NCT NCT03367910)
NCT ID: NCT03367910
Last Updated: 2022-03-18
Results Overview
The number, types, severity, and relation of adverse events to study procedures or product will be analyzed.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
1 participants
Primary outcome timeframe
Six months post-FMT
Results posted on
2022-03-18
Participant Flow
Participant milestones
| Measure |
FMT for MDRO UTI
Participants with eligible MDRO UTIs will receive FMT (150mL of RBX2660) via enema.
Fecal microbiota transplant: 150mL of FMT product RBX2660 delivered via enema
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fecal Microbiota Transplantation (FMT) for MDRO UTI
Baseline characteristics by cohort
| Measure |
FMT for MDRO UTI
n=1 Participants
Participants with eligible MDRO UTIs will receive FMT (150mL of RBX2660) via enema.
Fecal microbiota transplant: 150mL of FMT product RBX2660 delivered via enema
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Six months post-FMTThe number, types, severity, and relation of adverse events to study procedures or product will be analyzed.
Outcome measures
| Measure |
FMT for MDRO UTI
n=1 Participants
Participants with eligible MDRO UTIs will receive FMT (150mL of RBX2660) via enema.
Fecal microbiota transplant: 150mL of FMT product RBX2660 delivered via enema
|
|---|---|
|
Number of Patients With Adverse Events During and After FMT
|
1 Participants
|
SECONDARY outcome
Timeframe: Six months post-FMTRisk of recurrent UTI post-FMT will be evaluated
Outcome measures
| Measure |
FMT for MDRO UTI
n=1 Participants
Participants with eligible MDRO UTIs will receive FMT (150mL of RBX2660) via enema.
Fecal microbiota transplant: 150mL of FMT product RBX2660 delivered via enema
|
|---|---|
|
Number of Patients With Recurrent UTI Post-FMT
|
1 Participants
|
Adverse Events
FMT for MDRO UTI
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
FMT for MDRO UTI
n=1 participants at risk
Participants with eligible MDRO UTIs will receive FMT (150mL of RBX2660) via enema.
Fecal microbiota transplant: 150mL of FMT product RBX2660 delivered via enema
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
1/1 • Number of events 1 • 6 months
|
Additional Information
Kimberly Reske, Research Coordinator
Washington University in St. Louis School of Medicine
Phone: 3147474041
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place