Trial Outcomes & Findings for FMT for Multidrug Resistant Organism Reversal (NCT NCT02312986)

NCT ID: NCT02312986

Last Updated: 2021-02-24

Results Overview

Incidence and severity of solicited and serious adverse events within 12 months of FMT.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 1 participants
• Primary outcome timeframe: 12 months post-FMT
• Results posted on: 2021-02-24

Participant Flow

Participant milestones

Measure	Fecal Microbiota Transplantation Subjects will receive 150mL of fecal microbiota product via enema. Fecal microbiota transplantation (FMT): Prospective pilot study to examine whether fecal microbiota transplantation (FMT) is able to suppress or reverse gastrointestinal carriage of multi-drug resistant organisms.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

FMT for Multidrug Resistant Organism Reversal

Baseline characteristics by cohort

Measure	Fecal Microbiota Transplantation n=1 Participants Subjects will receive 150mL of fecal microbiota product via enema. Fecal microbiota transplantation (FMT): Prospective pilot study to examine whether fecal microbiota transplantation (FMT) is able to suppress or reverse gastrointestinal carriage of multi-drug resistant organisms.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	1 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	1 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	1 participants n=93 Participants

PRIMARY outcome

Timeframe: 12 months post-FMT

Incidence and severity of solicited and serious adverse events within 12 months of FMT.

Outcome measures

Measure	Fecal Microbiota Transplantation n=1 Participants Subjects will receive 150mL of fecal microbiota product via enema. Fecal microbiota transplantation (FMT): Prospective pilot study to examine whether fecal microbiota transplantation (FMT) is able to suppress or reverse gastrointestinal carriage of multi-drug resistant organisms.
Safety of FMT in Patients With Recurrent MDRO Infections (Incidence and Severity of Solicited and Serious Adverse Events) Solicited adverse events related to FMT	0 Participants
Safety of FMT in Patients With Recurrent MDRO Infections (Incidence and Severity of Solicited and Serious Adverse Events) Any serious adverse event	1 Participants

SECONDARY outcome

Timeframe: 30 days, 6 months, and 12 months post-FMT

Number of subjects with MDRO infections 30 days, 6 months, and 12 months post-FMT.

Outcome measures

Measure	Fecal Microbiota Transplantation n=1 Participants Subjects will receive 150mL of fecal microbiota product via enema. Fecal microbiota transplantation (FMT): Prospective pilot study to examine whether fecal microbiota transplantation (FMT) is able to suppress or reverse gastrointestinal carriage of multi-drug resistant organisms.
MDRO Infection Status Post-FMT (Number of Subjects With MDRO Infections) MDRO infection at 30 days	0 Participants
MDRO Infection Status Post-FMT (Number of Subjects With MDRO Infections) MDRO infection at 6 months post-FMT	1 Participants
MDRO Infection Status Post-FMT (Number of Subjects With MDRO Infections) MDRO infection at 12 months	0 Participants

Adverse Events

Fecal Microbiota Transplantation

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Fecal Microbiota Transplantation n=1 participants at risk Subjects will receive 150mL of fecal microbiota product via enema. Fecal microbiota transplantation (FMT): Prospective pilot study to examine whether fecal microbiota transplantation (FMT) is able to suppress or reverse gastrointestinal carriage of multi-drug resistant organisms.
Skin and subcutaneous tissue disorders Gangrene	100.0% 1/1 • Number of events 1 • 12 months
Renal and urinary disorders Urinary tract infection	100.0% 1/1 • Number of events 1 • 12 months
Musculoskeletal and connective tissue disorders Fracture	100.0% 1/1 • Number of events 1 • 12 months
General disorders Fever	100.0% 1/1 • Number of events 1 • 12 months
Skin and subcutaneous tissue disorders Oropharyngeal squamous cell carcinoma	100.0% 1/1 • Number of events 1 • 12 months

Other adverse events

Measure	Fecal Microbiota Transplantation n=1 participants at risk Subjects will receive 150mL of fecal microbiota product via enema. Fecal microbiota transplantation (FMT): Prospective pilot study to examine whether fecal microbiota transplantation (FMT) is able to suppress or reverse gastrointestinal carriage of multi-drug resistant organisms.
Gastrointestinal disorders Diarrhea	100.0% 1/1 • Number of events 1 • 12 months

Additional Information

Kimberly Reske, MPH, Research Coordinator

Washington University in St. Louis

Phone: 314-747-4041

Email: kreske@wustl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place