Trial Outcomes & Findings for A Trial of Encapsulated Fecal Microbiota for Vancomycin Resistant Enterococcus Decolonization (NCT NCT03063437)
NCT ID: NCT03063437
Last Updated: 2020-04-13
Results Overview
VRE decolonization is defined by absence of VRE on stool culture using standard clinical laboratory techniques at Day 10 (± 3 days) after randomization.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
9 participants
Primary outcome timeframe
Day 10 (±3 days) after randomization
Results posted on
2020-04-13
Participant Flow
Participants were recruited at the listed tertiary academic hospitals from August 15, 2017 to September 30, 2018.
Participant milestones
| Measure |
Active: Encapsulated Fecal Microbiota Preparation
Single dose of oral, encapsulated fecal microbiota preparation (30 capsules per dose) with follow-up at 3 days, 10 days, 28 days, and 6 months.
|
Placebo: Encapsulated Placebo
Single dose of oral, placebo capsule (30 capsules per dose) with follow-up at 3 days, 10 days, 28 days, and 6 months.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
5
|
|
Overall Study
COMPLETED
|
4
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Trial of Encapsulated Fecal Microbiota for Vancomycin Resistant Enterococcus Decolonization
Baseline characteristics by cohort
| Measure |
Active: Encapsulated Fecal Microbiota Preparation
n=4 Participants
Single dose of oral, encapsulated fecal microbiota preparation (30 capsules per dose) with follow-up at 3 days, 10 days, 28 days, and 6 months.
|
Placebo: Encapsulated Placebo
n=5 Participants
Single dose of oral, placebo capsule (30 capsules per dose) with follow-up at 3 days, 10 days, 28 days, and 6 months.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 10 (±3 days) after randomizationVRE decolonization is defined by absence of VRE on stool culture using standard clinical laboratory techniques at Day 10 (± 3 days) after randomization.
Outcome measures
| Measure |
Active: Encapsulated Fecal Microbiota Preparation
n=4 Participants
Single dose of oral, encapsulated fecal microbiota preparation (30 capsules per dose) with follow-up at 3 days, 10 days, 28 days, and 6 months.
|
Placebo: Encapsulated Placebo
n=5 Participants
Single dose of oral, placebo capsule (30 capsules per dose) with follow-up at 3 days, 10 days, 28 days, and 6 months.
|
|---|---|---|
|
Percentage of Participants With VRE Decolonization
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Day 10 (±3 days) after randomizationPercentage of participants with an adverse event (AE); severe adverse event (SAE); and newly acquired transmissible infectious diseases which are considered adverse events of special interest (AESI) through Day 10 (± 3 days) after randomization.
Outcome measures
| Measure |
Active: Encapsulated Fecal Microbiota Preparation
n=4 Participants
Single dose of oral, encapsulated fecal microbiota preparation (30 capsules per dose) with follow-up at 3 days, 10 days, 28 days, and 6 months.
|
Placebo: Encapsulated Placebo
n=5 Participants
Single dose of oral, placebo capsule (30 capsules per dose) with follow-up at 3 days, 10 days, 28 days, and 6 months.
|
|---|---|---|
|
Percentage of Participants With an Adverse Event (AE); Severe Adverse Event (SAE); and Newly Acquired Transmissible Infectious Diseases Which Are Considered Adverse Events of Special Interest (AESI)
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Week 4 (±5 days) after randomizationPercentage of participants with VRE infection, defined as an associated bacteremia, urinary tract infection, or wound-related infection.
Outcome measures
| Measure |
Active: Encapsulated Fecal Microbiota Preparation
n=4 Participants
Single dose of oral, encapsulated fecal microbiota preparation (30 capsules per dose) with follow-up at 3 days, 10 days, 28 days, and 6 months.
|
Placebo: Encapsulated Placebo
n=5 Participants
Single dose of oral, placebo capsule (30 capsules per dose) with follow-up at 3 days, 10 days, 28 days, and 6 months.
|
|---|---|---|
|
Percentage of Participants With VRE Infection
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 10 (± 3 days) after randomizationPopulation: Data not collected as no participants in the trial entered the study colonized with an ARB other than VRE
Percentage of participants with other antibiotic resistant bacteria (ARB) colonization
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 4 (±5 days) after randomizationPopulation: Data not collected as no participants in the trial entered the study colonized with an ARB other than VRE
Percentage of participants with composite ARB infection
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 6 months after randomizationPopulation: Data not collected as no participants in the trial were colonized and infected by VRE following randomization.
Time (in days) from randomization until the study day when VRE colonization and infection occurs
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 10 (± 3 days) after randomizationPercentage of participants with VRE decolonization among immunocompromised patients
Outcome measures
| Measure |
Active: Encapsulated Fecal Microbiota Preparation
n=4 Participants
Single dose of oral, encapsulated fecal microbiota preparation (30 capsules per dose) with follow-up at 3 days, 10 days, 28 days, and 6 months.
|
Placebo: Encapsulated Placebo
n=4 Participants
Single dose of oral, placebo capsule (30 capsules per dose) with follow-up at 3 days, 10 days, 28 days, and 6 months.
|
|---|---|---|
|
VRE Decolonization Among Immunocompromised Patients
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Week 4 (±5 days) after randomizationPercentage of participants with an adverse event (AE)
Outcome measures
| Measure |
Active: Encapsulated Fecal Microbiota Preparation
n=4 Participants
Single dose of oral, encapsulated fecal microbiota preparation (30 capsules per dose) with follow-up at 3 days, 10 days, 28 days, and 6 months.
|
Placebo: Encapsulated Placebo
n=5 Participants
Single dose of oral, placebo capsule (30 capsules per dose) with follow-up at 3 days, 10 days, 28 days, and 6 months.
|
|---|---|---|
|
Adverse Events Within 4 Weeks Following FMT
|
3 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Week 4 (±5 days) after randomizationPercentage of participants with a serious adverse event (SAE)
Outcome measures
| Measure |
Active: Encapsulated Fecal Microbiota Preparation
n=4 Participants
Single dose of oral, encapsulated fecal microbiota preparation (30 capsules per dose) with follow-up at 3 days, 10 days, 28 days, and 6 months.
|
Placebo: Encapsulated Placebo
n=5 Participants
Single dose of oral, placebo capsule (30 capsules per dose) with follow-up at 3 days, 10 days, 28 days, and 6 months.
|
|---|---|---|
|
Serious Adverse Events Within 4 Weeks Following FMT
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 4 (±5 days) after randomizationPercentage of participants with newly acquired transmissible infectious diseases which are considered adverse events of special interest (AESI)
Outcome measures
| Measure |
Active: Encapsulated Fecal Microbiota Preparation
n=4 Participants
Single dose of oral, encapsulated fecal microbiota preparation (30 capsules per dose) with follow-up at 3 days, 10 days, 28 days, and 6 months.
|
Placebo: Encapsulated Placebo
n=5 Participants
Single dose of oral, placebo capsule (30 capsules per dose) with follow-up at 3 days, 10 days, 28 days, and 6 months.
|
|---|---|---|
|
Newly Acquired Transmissible Infectious Diseases Which Are Considered Adverse Events of Special Interest (AESI)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Month 6 (±14 days) phone safety assessment after randomizationPercentage of participants with a Serious Adverse Event (SAE)
Outcome measures
| Measure |
Active: Encapsulated Fecal Microbiota Preparation
n=4 Participants
Single dose of oral, encapsulated fecal microbiota preparation (30 capsules per dose) with follow-up at 3 days, 10 days, 28 days, and 6 months.
|
Placebo: Encapsulated Placebo
n=5 Participants
Single dose of oral, placebo capsule (30 capsules per dose) with follow-up at 3 days, 10 days, 28 days, and 6 months.
|
|---|---|---|
|
Serious Adverse Events Within 6 Months Following FMT
|
2 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 3, day 10, week 4 after randomization.To evaluate the microbiome disruption index (MDI) by 16s rRNA sequencing): MDI-community and MDI-species
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 months following FMTTo evaluate the trends in VRE type/strain-level engraftment using whole genome sequencing among those colonized
Outcome measures
Outcome data not reported
Adverse Events
Active: Encapsulated Fecal Microbiota Preparation
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo: Encapsulated Placebo
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active: Encapsulated Fecal Microbiota Preparation
n=4 participants at risk
Encapsulated fecal microbiota preparation: 30 capsules
|
Placebo: Encapsulated Placebo
n=5 participants at risk
Encapsulated placebo: 30 capsules
|
|---|---|---|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/4 • Adverse events were collected for 6 months after randomization,
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for 6 months after randomization,
|
|
Cardiac disorders
Congestive Heart Failure
|
25.0%
1/4 • Number of events 1 • Adverse events were collected for 6 months after randomization,
|
0.00%
0/5 • Adverse events were collected for 6 months after randomization,
|
|
Hepatobiliary disorders
Jaundice
|
25.0%
1/4 • Number of events 1 • Adverse events were collected for 6 months after randomization,
|
0.00%
0/5 • Adverse events were collected for 6 months after randomization,
|
Other adverse events
| Measure |
Active: Encapsulated Fecal Microbiota Preparation
n=4 participants at risk
Encapsulated fecal microbiota preparation: 30 capsules
|
Placebo: Encapsulated Placebo
n=5 participants at risk
Encapsulated placebo: 30 capsules
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
25.0%
1/4 • Number of events 1 • Adverse events were collected for 6 months after randomization,
|
0.00%
0/5 • Adverse events were collected for 6 months after randomization,
|
|
Eye disorders
Dry Eye
|
0.00%
0/4 • Adverse events were collected for 6 months after randomization,
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for 6 months after randomization,
|
|
Gastrointestinal disorders
Abdominal pain
|
25.0%
1/4 • Number of events 1 • Adverse events were collected for 6 months after randomization,
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for 6 months after randomization,
|
|
Gastrointestinal disorders
Abdominal distention
|
25.0%
1/4 • Number of events 1 • Adverse events were collected for 6 months after randomization,
|
40.0%
2/5 • Number of events 2 • Adverse events were collected for 6 months after randomization,
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • Adverse events were collected for 6 months after randomization,
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for 6 months after randomization,
|
|
Gastrointestinal disorders
Diarrhea
|
75.0%
3/4 • Number of events 3 • Adverse events were collected for 6 months after randomization,
|
40.0%
2/5 • Number of events 2 • Adverse events were collected for 6 months after randomization,
|
|
Gastrointestinal disorders
Nausea
|
50.0%
2/4 • Number of events 2 • Adverse events were collected for 6 months after randomization,
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for 6 months after randomization,
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
1/4 • Number of events 1 • Adverse events were collected for 6 months after randomization,
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for 6 months after randomization,
|
|
Gastrointestinal disorders
Discolored stool
|
0.00%
0/4 • Adverse events were collected for 6 months after randomization,
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for 6 months after randomization,
|
|
General disorders
Pyrexia
|
25.0%
1/4 • Number of events 1 • Adverse events were collected for 6 months after randomization,
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for 6 months after randomization,
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • Adverse events were collected for 6 months after randomization,
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for 6 months after randomization,
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/4 • Adverse events were collected for 6 months after randomization,
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for 6 months after randomization,
|
|
Gastrointestinal disorders
Throat pain
|
0.00%
0/4 • Adverse events were collected for 6 months after randomization,
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for 6 months after randomization,
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • Adverse events were collected for 6 months after randomization,
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for 6 months after randomization,
|
|
General disorders
Loss of appetite
|
0.00%
0/4 • Adverse events were collected for 6 months after randomization,
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for 6 months after randomization,
|
|
Hepatobiliary disorders
Elevated liver function tests
|
25.0%
1/4 • Number of events 1 • Adverse events were collected for 6 months after randomization,
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for 6 months after randomization,
|
|
Immune system disorders
Polymyalgia rheumatica
|
0.00%
0/4 • Adverse events were collected for 6 months after randomization,
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for 6 months after randomization,
|
|
Infections and infestations
CMV re-activation
|
0.00%
0/4 • Adverse events were collected for 6 months after randomization,
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for 6 months after randomization,
|
|
Metabolism and nutrition disorders
Gout
|
25.0%
1/4 • Number of events 1 • Adverse events were collected for 6 months after randomization,
|
0.00%
0/5 • Adverse events were collected for 6 months after randomization,
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/4 • Adverse events were collected for 6 months after randomization,
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for 6 months after randomization,
|
|
Respiratory, thoracic and mediastinal disorders
Acute sinusitis
|
0.00%
0/4 • Adverse events were collected for 6 months after randomization,
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for 6 months after randomization,
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
25.0%
1/4 • Number of events 1 • Adverse events were collected for 6 months after randomization,
|
0.00%
0/5 • Adverse events were collected for 6 months after randomization,
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • Adverse events were collected for 6 months after randomization,
|
20.0%
1/5 • Number of events 1 • Adverse events were collected for 6 months after randomization,
|
Additional Information
Majdi Osman, MD, MPH
Microbiome Health Research Institute
Phone: 6175752201
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place