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A Trial of Encapsulated Fecal Microbiota for Vancomycin Resistant Enterococcus Decolonization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03063437
Recruitment Status : Completed
First Posted : February 24, 2017
Results First Posted : February 5, 2020
Last Update Posted : April 13, 2020
Sponsor:
Collaborators:
University of Wisconsin, Madison
Indiana University
Information provided by (Responsible Party):
Microbiome Health Research Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Antibiotic Resistant Strain
Interventions Biological: Encapsulated fecal microbiota preparation
Biological: Encapsulated placebo
Enrollment 9
Recruitment Details Participants were recruited at the listed tertiary academic hospitals from August 15, 2017 to September 30, 2018.
Pre-assignment Details  
Arm/Group Title Active: Encapsulated Fecal Microbiota Preparation Placebo: Encapsulated Placebo
Hide Arm/Group Description 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. Single dose of oral, placebo capsule (30 capsules per dose) with follow-up at 3 days, 10 days, 28 days, and 6 months.
Period Title: Overall Study
Started 4 5
Completed 4 5
Not Completed 0 0
Arm/Group Title Active: Encapsulated Fecal Microbiota Preparation Placebo: Encapsulated Placebo Total
Hide Arm/Group Description 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. Single dose of oral, placebo capsule (30 capsules per dose) with follow-up at 3 days, 10 days, 28 days, and 6 months. Total of all reporting groups
Overall Number of Baseline Participants 4 5 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 9 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
3
  75.0%
4
  80.0%
7
  77.8%
>=65 years
1
  25.0%
1
  20.0%
2
  22.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 9 participants
Female
1
  25.0%
2
  40.0%
3
  33.3%
Male
3
  75.0%
3
  60.0%
6
  66.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 9 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
2
  50.0%
5
 100.0%
7
  77.8%
Unknown or Not Reported
2
  50.0%
0
   0.0%
2
  22.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 5 participants 9 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
4
 100.0%
5
 100.0%
9
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Participants With VRE Decolonization
Hide Description VRE decolonization is defined by absence of VRE on stool culture using standard clinical laboratory techniques at Day 10 (± 3 days) after randomization.
Time Frame Day 10 (±3 days) after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active: Encapsulated Fecal Microbiota Preparation Placebo: Encapsulated Placebo
Hide Arm/Group Description:
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.
Single dose of oral, placebo capsule (30 capsules per dose) with follow-up at 3 days, 10 days, 28 days, and 6 months.
Overall Number of Participants Analyzed 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
1
  25.0%
1
  20.0%
2.Primary Outcome
Title 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)
Hide Description 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) through Day 10 (± 3 days) after randomization.
Time Frame Day 10 (±3 days) after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active: Encapsulated Fecal Microbiota Preparation Placebo: Encapsulated Placebo
Hide Arm/Group Description:
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.
Single dose of oral, placebo capsule (30 capsules per dose) with follow-up at 3 days, 10 days, 28 days, and 6 months.
Overall Number of Participants Analyzed 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
3
  75.0%
5
 100.0%
3.Secondary Outcome
Title Percentage of Participants With VRE Infection
Hide Description Percentage of participants with VRE infection, defined as an associated bacteremia, urinary tract infection, or wound-related infection.
Time Frame Week 4 (±5 days) after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active: Encapsulated Fecal Microbiota Preparation Placebo: Encapsulated Placebo
Hide Arm/Group Description:
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.
Single dose of oral, placebo capsule (30 capsules per dose) with follow-up at 3 days, 10 days, 28 days, and 6 months.
Overall Number of Participants Analyzed 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
4.Secondary Outcome
Title Percentage of Participants With ARB Colonization on Day 10 Following Fecal Microbiota Transplantation (FMT)
Hide Description Percentage of participants with other antibiotic resistant bacteria (ARB) colonization
Time Frame Day 10 (± 3 days) after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected as no participants in the trial entered the study colonized with an ARB other than VRE
Arm/Group Title Active: Encapsulated Fecal Microbiota Preparation Placebo: Encapsulated Placebo
Hide Arm/Group Description:
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.
Single dose of oral, placebo capsule (30 capsules per dose) with follow-up at 3 days, 10 days, 28 days, and 6 months.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Percentage of Participants With ARB Infection 4 Weeks Following FMT
Hide Description Percentage of participants with composite ARB infection
Time Frame Week 4 (±5 days) after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected as no participants in the trial entered the study colonized with an ARB other than VRE
Arm/Group Title Active: Encapsulated Fecal Microbiota Preparation Placebo: Encapsulated Placebo
Hide Arm/Group Description:
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.
Single dose of oral, placebo capsule (30 capsules per dose) with follow-up at 3 days, 10 days, 28 days, and 6 months.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Number of Days Between FMT and VRE Colonization and Infection Occurs
Hide Description Time (in days) from randomization until the study day when VRE colonization and infection occurs
Time Frame Up to 6 months after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected as no participants in the trial were colonized and infected by VRE following randomization.
Arm/Group Title Active: Encapsulated Fecal Microbiota Preparation Placebo: Encapsulated Placebo
Hide Arm/Group Description:
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.
Single dose of oral, placebo capsule (30 capsules per dose) with follow-up at 3 days, 10 days, 28 days, and 6 months.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title VRE Decolonization Among Immunocompromised Patients
Hide Description Percentage of participants with VRE decolonization among immunocompromised patients
Time Frame Day 10 (± 3 days) after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active: Encapsulated Fecal Microbiota Preparation Placebo: Encapsulated Placebo
Hide Arm/Group Description:
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.
Single dose of oral, placebo capsule (30 capsules per dose) with follow-up at 3 days, 10 days, 28 days, and 6 months.
Overall Number of Participants Analyzed 4 4
Measure Type: Count of Participants
Unit of Measure: Participants
1
  25.0%
1
  25.0%
8.Secondary Outcome
Title Adverse Events Within 4 Weeks Following FMT
Hide Description Percentage of participants with an adverse event (AE)
Time Frame Week 4 (±5 days) after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active: Encapsulated Fecal Microbiota Preparation Placebo: Encapsulated Placebo
Hide Arm/Group Description:
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.
Single dose of oral, placebo capsule (30 capsules per dose) with follow-up at 3 days, 10 days, 28 days, and 6 months.
Overall Number of Participants Analyzed 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
3
  75.0%
5
 100.0%
9.Secondary Outcome
Title Serious Adverse Events Within 4 Weeks Following FMT
Hide Description Percentage of participants with a serious adverse event (SAE)
Time Frame Week 4 (±5 days) after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active: Encapsulated Fecal Microbiota Preparation Placebo: Encapsulated Placebo
Hide Arm/Group Description:
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.
Single dose of oral, placebo capsule (30 capsules per dose) with follow-up at 3 days, 10 days, 28 days, and 6 months.
Overall Number of Participants Analyzed 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
10.Secondary Outcome
Title Newly Acquired Transmissible Infectious Diseases Which Are Considered Adverse Events of Special Interest (AESI)
Hide Description Percentage of participants with newly acquired transmissible infectious diseases which are considered adverse events of special interest (AESI)
Time Frame Week 4 (±5 days) after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active: Encapsulated Fecal Microbiota Preparation Placebo: Encapsulated Placebo
Hide Arm/Group Description:
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.
Single dose of oral, placebo capsule (30 capsules per dose) with follow-up at 3 days, 10 days, 28 days, and 6 months.
Overall Number of Participants Analyzed 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
11.Secondary Outcome
Title Serious Adverse Events Within 6 Months Following FMT
Hide Description Percentage of participants with a Serious Adverse Event (SAE)
Time Frame Month 6 (±14 days) phone safety assessment after randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active: Encapsulated Fecal Microbiota Preparation Placebo: Encapsulated Placebo
Hide Arm/Group Description:
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.
Single dose of oral, placebo capsule (30 capsules per dose) with follow-up at 3 days, 10 days, 28 days, and 6 months.
Overall Number of Participants Analyzed 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
2
  50.0%
1
  20.0%
12.Other Pre-specified Outcome
Title Microbiome Disruption
Hide Description To evaluate the microbiome disruption index (MDI) by 16s rRNA sequencing): MDI-community and MDI-species
Time Frame Day 3, day 10, week 4 after randomization.
Outcome Measure Data Not Reported
13.Other Pre-specified Outcome
Title Engraftment Dynamics
Hide Description To evaluate the trends in VRE type/strain-level engraftment using whole genome sequencing among those colonized
Time Frame 6 months following FMT
Outcome Measure Data Not Reported
Time Frame Adverse events were collected for 6 months after randomization,
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active: Encapsulated Fecal Microbiota Preparation Placebo: Encapsulated Placebo
Hide Arm/Group Description Encapsulated fecal microbiota preparation: 30 capsules Encapsulated placebo: 30 capsules
All-Cause Mortality
Active: Encapsulated Fecal Microbiota Preparation Placebo: Encapsulated Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)      0/5 (0.00%)    
Hide Serious Adverse Events
Active: Encapsulated Fecal Microbiota Preparation Placebo: Encapsulated Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/4 (50.00%)      1/5 (20.00%)    
Cardiac disorders     
Congestive Heart Failure   1/4 (25.00%)  1 0/5 (0.00%)  0
Hepatobiliary disorders     
Cholangitis   0/4 (0.00%)  0 1/5 (20.00%)  1
Jaundice   1/4 (25.00%)  1 0/5 (0.00%)  0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Active: Encapsulated Fecal Microbiota Preparation Placebo: Encapsulated Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/4 (75.00%)      5/5 (100.00%)    
Ear and labyrinth disorders     
Ear pain   0/4 (0.00%)  0 1/5 (20.00%)  1
Eye disorders     
Dry Eye   0/4 (0.00%)  0 1/5 (20.00%)  1
Gastrointestinal disorders     
Abdominal pain   1/4 (25.00%)  1 1/5 (20.00%)  1
Abdominal distention   1/4 (25.00%)  1 2/5 (40.00%)  2
Constipation   0/4 (0.00%)  0 1/5 (20.00%)  1
Diarrhea   3/4 (75.00%)  3 2/5 (40.00%)  2
Nausea   2/4 (50.00%)  2 1/5 (20.00%)  1
Vomiting   1/4 (25.00%)  1 1/5 (20.00%)  1
Discolored stool   0/4 (0.00%)  0 1/5 (20.00%)  1
Throat pain   0/4 (0.00%)  0 1/5 (20.00%)  1
General disorders     
Pyrexia  [1]  1/4 (25.00%)  1 1/5 (20.00%)  1
Loss of appetite   0/4 (0.00%)  0 1/5 (20.00%)  1
Hepatobiliary disorders     
Elevated liver function tests   1/4 (25.00%)  1 1/5 (20.00%)  1
Immune system disorders     
Polymyalgia rheumatica   0/4 (0.00%)  0 1/5 (20.00%)  1
Infections and infestations     
CMV re-activation  [2]  0/4 (0.00%)  0 1/5 (20.00%)  1
Metabolism and nutrition disorders     
Dehydration   0/4 (0.00%)  0 1/5 (20.00%)  1
Gout   1/4 (25.00%)  1 0/5 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Osteoporosis   1/4 (25.00%)  1 0/5 (0.00%)  0
Renal and urinary disorders     
Urinary tract infection   0/4 (0.00%)  0 1/5 (20.00%)  1
Respiratory, thoracic and mediastinal disorders     
Nasal congestion   0/4 (0.00%)  0 1/5 (20.00%)  1
Acute sinusitis   0/4 (0.00%)  0 1/5 (20.00%)  1
Upper respiratory infection   1/4 (25.00%)  1 0/5 (0.00%)  0
Skin and subcutaneous tissue disorders     
Rash   0/4 (0.00%)  0 1/5 (20.00%)  1
Indicates events were collected by systematic assessment
[1]
General disorders and administration site conditions
[2]
Cytomegalovirus (CMV) re-activation
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Majdi Osman, MD, MPH
Organization: Microbiome Health Research Institute
Phone: 6175752201
EMail: majdi@openbiome.org
Layout table for additonal information
Responsible Party: Microbiome Health Research Institute
ClinicalTrials.gov Identifier: NCT03063437    
Other Study ID Numbers: 200-2016-91948
First Submitted: February 17, 2017
First Posted: February 24, 2017
Results First Submitted: January 15, 2020
Results First Posted: February 5, 2020
Last Update Posted: April 13, 2020