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Trial record 59 of 259 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND broad

Safety and Efficacy of Fecal Microbiome Transplantation (FMT) in the Treatment of Antibiotic Dependent Pouchitis (ADP)

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: NCT02782325
Recruitment Status : Terminated (Due low efficacy of FMT in interim analysis.)
First Posted : May 25, 2016
Results First Posted : May 14, 2019
Last Update Posted : May 14, 2019
Sponsor:
Collaborators:
OpenBiome
Crohn's and Colitis Foundation
The Broad Foundation
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pouchitis
Interventions Biological: Active FMT, then open label FMT
Biological: Placebo FMT, then open label FMT
Enrollment 6
Recruitment Details  
Pre-assignment Details 1 patient after screening since he met an exclusion criterion. 6 patients went on to randomization
Arm/Group Title Active FMT, Then Open Label FMT Placebo FMT, Then Open Label FMT Open Label FMT Period
Hide Arm/Group Description Endoscopic application of OpenBiome FMT Lower Delivery followed by 2 weeks of treatment with OpenBiome FMT Capsules G3 with follow-up at week 4, 8, 16 and 24 after inclusion. In case the study patient does not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study he/she will be offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an additional endoscopic FMT followed by 2 weeks of oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT. Endoscopic application of Placebo FMT Lower Delivery followed by 2 weeks of treatment with Placebo FMT Capsules G3 with follow-up at week 4, 8, 16 and 24 after inclusion. In case the study patient does not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study he/she will be offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an additional endoscopic FMT followed by 2 weeks of oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT. Participants who do not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study were offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an open label endoscopic FMT followed by 2 weeks of open label oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT.
Period Title: Blinded FMT Treatment (up to 24 Weeks)
Started 4 2 0
Completed 0 0 0
Not Completed 4 2 0
Reason Not Completed
Lack of Efficacy             4             2             0
Period Title: Open Label FMT Period (up to 24 Weeks)
Started [1] 0 0 5 [2]
Completed 0 0 1
Not Completed 0 0 4
Reason Not Completed
Lack of Efficacy             0             0             4
[1]
One patient declined participation in the open label extension arm
[2]
1 participant decided to not participate in the open label period
Arm/Group Title Active FMT, Then Open Label FMT Placebo FMT, Then Open Label FMT Total
Hide Arm/Group Description Endoscopic application of OpenBiome FMT Lower Delivery followed by 2 weeks of treatment with OpenBiome FMT Capsules G3 with follow-up at week 4, 8, 16 and 24 after inclusion. In case the study patient does not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study he/she will be offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an additional endoscopic FMT followed by 2 weeks of oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT. Endoscopic application of Placebo FMT Lower Delivery followed by 2 weeks of treatment with Placebo FMT Capsules G3 with follow-up at week 4, 8, 16 and 24 after inclusion. In case the study patient does not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study he/she will be offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an additional endoscopic FMT followed by 2 weeks of oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT. Total of all reporting groups
Overall Number of Baseline Participants 4 2 6
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 2 participants 6 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
4
 100.0%
2
 100.0%
6
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 2 participants 6 participants
Female
0
   0.0%
2
 100.0%
2
  33.3%
Male
4
 100.0%
0
   0.0%
4
  66.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 2 participants 6 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%
2
 100.0%
6
 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%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 4 participants 2 participants 6 participants
4
 100.0%
2
 100.0%
6
 100.0%
1.Primary Outcome
Title Number of Patients With FMT Related Adverse Event
Hide Description Number of patients with FMT related adverse event (classified according to MedDRA; lowest level term) and categorized according to CTCAE Version 4.0. The safety was assessed in the randomized placebo controlled segment of the study over 24 weeks after initial endoscopic FMT weeks and if the patient should enter the open label extension part of the study also for 24 weeks after initial open label FMT. 6 patients participated in the randomized arm and 5 patients in the open label extension arm.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Randomized Phase: Active FMT Randomized Phase: Placebo Open Label FMT
Hide Arm/Group Description:
Endoscopic application of OpenBiome FMT Lower Delivery followed by 2 weeks of treatment with OpenBiome FMT Capsules G3 with follow-up at week 4, 8, 16 and 24 after inclusion. In case the study patient does not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study he/she will be offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an additional endoscopic FMT followed by 2 weeks of oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT.
Endoscopic application of Placebo FMT Lower Delivery followed by 2 weeks of treatment with Placebo FMT Capsules G3 with follow-up at week 4, 8, 16 and 24 after inclusion. In case the study patient does not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study he/she will be offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an additional endoscopic FMT followed by 2 weeks of oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT.
Participants who do not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study were offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an open label endoscopic FMT followed by 2 weeks of open label oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT.
Overall Number of Participants Analyzed 4 2 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
2.Secondary Outcome
Title Number of Patients in Clinical Remission Week 4 After Endoscopic and Oral FMT
Hide Description Clinical remission as defined by a composite assessment, of which all criteria need to be met: Clinical modified pouch diseases activity index (mPDAI) score ≤4 points and no need for antibiotic therapy at week 4.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Randomized Phase: Active FMT Randomized Phase: Placebo Open Label FMT
Hide Arm/Group Description:
Endoscopic application of OpenBiome FMT Lower Delivery followed by 2 weeks of treatment with OpenBiome FMT Capsules G3 with follow-up at week 4, 8, 16 and 24 after inclusion. In case the study patient does not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study he/she will be offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an additional endoscopic FMT followed by 2 weeks of oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT.
Endoscopic application of Placebo FMT Lower Delivery followed by 2 weeks of treatment with Placebo FMT Capsules G3 with follow-up at week 4, 8, 16 and 24 after inclusion. In case the study patient does not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study he/she will be offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an additional endoscopic FMT followed by 2 weeks of oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT.
Participants who do not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study were offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an open label endoscopic FMT followed by 2 weeks of open label oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT.
Overall Number of Participants Analyzed 4 2 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
1
  20.0%
3.Secondary Outcome
Title Number of Patients in Clinical Remission Week 16
Hide Description Clinical remission as defined by a composite assessment, of which all criteria need to be met: Clinical mPDAI score ≤4 points and no need for antibiotic therapy at week 16.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Randomized Phase: Active FMT Randomized Phase: Placebo Open Label FMT
Hide Arm/Group Description:
Endoscopic application of OpenBiome FMT Lower Delivery followed by 2 weeks of treatment with OpenBiome FMT Capsules G3 with follow-up at week 4, 8, 16 and 24 after inclusion. In case the study patient does not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study he/she will be offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an additional endoscopic FMT followed by 2 weeks of oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT.
Endoscopic application of Placebo FMT Lower Delivery followed by 2 weeks of treatment with Placebo FMT Capsules G3 with follow-up at week 4, 8, 16 and 24 after inclusion. In case the study patient does not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study he/she will be offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an additional endoscopic FMT followed by 2 weeks of oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT.
Participants who do not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study were offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an open label endoscopic FMT followed by 2 weeks of open label oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT.
Overall Number of Participants Analyzed 4 2 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
1
  20.0%
4.Secondary Outcome
Title Number of Patients With Endoscopic Improvement Week 4 After Endoscopic and Oral FMT
Hide Description Endoscopic improvement of active pouchitis (decrease from baseline in modified pouch disease activity index endoscopic subscore > 2 points) at week 4.
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
None of the patients in the randomized phase underwent an endoscopy at week 4 since they all relapsed before week 4. In the open label extension only 1 patient underwent endoscopy at week 4 and the pouch was endoscopically unchanged.
Arm/Group Title Randomized Phase: Active FMT Randomized Phase: Placebo Open Label FMT
Hide Arm/Group Description:
Endoscopic application of OpenBiome FMT Lower Delivery followed by 2 weeks of treatment with OpenBiome FMT Capsules G3 with follow-up at week 4, 8, 16 and 24 after inclusion. In case the study patient does not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study he/she will be offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an additional endoscopic FMT followed by 2 weeks of oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT.
Endoscopic application of Placebo FMT Lower Delivery followed by 2 weeks of treatment with Placebo FMT Capsules G3 with follow-up at week 4, 8, 16 and 24 after inclusion. In case the study patient does not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study he/she will be offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an additional endoscopic FMT followed by 2 weeks of oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT.
Participants who do not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study were offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an open label endoscopic FMT followed by 2 weeks of open label oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT.
Overall Number of Participants Analyzed 0 0 1
Measure Type: Count of Participants
Unit of Measure: Participants
0 0
0
   0.0%
5.Secondary Outcome
Title Number of Patients With Clinical Response at Week 4 in Patients Entering the Trial With Active Pouchitis Symptoms
Hide Description

This outcome measure is for patients with active pouchitis symptoms entering the trial. Since all patients entered with inactive pouchitis no patient could be evaluated for this outcome.

Response as defined by a composite assessment of which both criteria has to be met: Decrease from baseline mPDAI clinical subscore > 2 points and no need for antibiotic therapy at week 4.

Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Since all patients entered with inactive pouchitis no patient could be evaluated for this outcome.
Arm/Group Title Randomized Phase: Active FMT Randomized Phase: Placebo Open Label FMT
Hide Arm/Group Description:
Endoscopic application of OpenBiome FMT Lower Delivery followed by 2 weeks of treatment with OpenBiome FMT Capsules G3 with follow-up at week 4, 8, 16 and 24 after inclusion. In case the study patient does not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study he/she will be offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an additional endoscopic FMT followed by 2 weeks of oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT.
Endoscopic application of Placebo FMT Lower Delivery followed by 2 weeks of treatment with Placebo FMT Capsules G3 with follow-up at week 4, 8, 16 and 24 after inclusion. In case the study patient does not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study he/she will be offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an additional endoscopic FMT followed by 2 weeks of oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT.
Participants who do not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study were offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an open label endoscopic FMT followed by 2 weeks of open label oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Number of Patients With Clinical Response Week 8 and Active Pouchitis at Baseline
Hide Description Response as defined by a composite assessment of which both criteria has to be met: Decrease from baseline mPDAI clinical subscore > 2 points and no need for antibiotic therapy at week 8 of the randomized phase.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Only 1 patient in the open label FMT completed the week 8 visit, but entered the trial in remission and thus did n to meet the criterion of a decrease of the clinical PDA sub core decrease
Arm/Group Title Randomized Phase: Active FMT Randomized Phase: Placebo Open Label FMT
Hide Arm/Group Description:
Endoscopic application of OpenBiome FMT Lower Delivery followed by 2 weeks of treatment with OpenBiome FMT Capsules G3 with follow-up at week 4, 8, 16 and 24 after inclusion. In case the study patient does not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study he/she will be offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an additional endoscopic FMT followed by 2 weeks of oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT.
Endoscopic application of Placebo FMT Lower Delivery followed by 2 weeks of treatment with Placebo FMT Capsules G3 with follow-up at week 4, 8, 16 and 24 after inclusion. In case the study patient does not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study he/she will be offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an additional endoscopic FMT followed by 2 weeks of oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT.
Participants who do not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study were offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an open label endoscopic FMT followed by 2 weeks of open label oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT.
Overall Number of Participants Analyzed 0 0 1
Measure Type: Count of Participants
Unit of Measure: Participants
0 0
0
   0.0%
7.Secondary Outcome
Title Number of Patients With Clinical Response i at Week 16 and Active Pouchitis at Baseline
Hide Description This outcome measure is for patients with active pouchitis symptoms entering the trial. Response as defined by a composite assessment of which both criteria has to be met: Decrease from baseline mPDAI clinical subscore > 2 points and no need for antibiotic therapy at week 16.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
None of the patients in the trial entered the study with symptoms of active pouchitis
Arm/Group Title Randomized Phase: Active FMT Randomized Phase: Placebo Open Label FMT
Hide Arm/Group Description:
Endoscopic application of OpenBiome FMT Lower Delivery followed by 2 weeks of treatment with OpenBiome FMT Capsules G3 with follow-up at week 4, 8, 16 and 24 after inclusion. In case the study patient does not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study he/she will be offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an additional endoscopic FMT followed by 2 weeks of oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT.
Endoscopic application of Placebo FMT Lower Delivery followed by 2 weeks of treatment with Placebo FMT Capsules G3 with follow-up at week 4, 8, 16 and 24 after inclusion. In case the study patient does not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study he/she will be offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an additional endoscopic FMT followed by 2 weeks of oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT.
Participants who do not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study were offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an open label endoscopic FMT followed by 2 weeks of open label oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse event were collected for 24 weeks after endoscopic FMT in the randomized phase. If patient the patient participated in the open label extension study period adverse events were collected for 24 weeks after endoscopic FMT in the open label extension phase.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Randomized Phase: Active FMT Randomized Phase: Placebo Open Label FMT
Hide Arm/Group Description Endoscopic application of OpenBiome FMT Lower Delivery followed by 2 weeks of treatment with OpenBiome FMT Capsules G3 with follow-up at week 4, 8, 16 and 24 after inclusion. In case the study patient does not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study he/she will be offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an additional endoscopic FMT followed by 2 weeks of oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT. Endoscopic application of Placebo FMT Lower Delivery followed by 2 weeks of treatment with Placebo FMT Capsules G3 with follow-up at week 4, 8, 16 and 24 after inclusion. In case the study patient does not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study he/she will be offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an additional endoscopic FMT followed by 2 weeks of oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT. Participants who do not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study were offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an open label endoscopic FMT followed by 2 weeks of open label oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT.
All-Cause Mortality
Randomized Phase: Active FMT Randomized Phase: Placebo Open Label FMT
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)      0/2 (0.00%)      0/5 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Randomized Phase: Active FMT Randomized Phase: Placebo Open Label FMT
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      0/2 (0.00%)      0/5 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Randomized Phase: Active FMT Randomized Phase: Placebo Open Label FMT
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/4 (100.00%)      2/2 (100.00%)      5/5 (100.00%)    
Gastrointestinal disorders       
Nausea  1  0/4 (0.00%)  0 1/2 (50.00%)  1 0/5 (0.00%)  0
Bloating  1  3/4 (75.00%)  3 2/2 (100.00%)  2 3/5 (60.00%)  3
Urgency  2  3/4 (75.00%)  3 0/2 (0.00%)  0 1/5 (20.00%)  1
Diarrhea  2  3/4 (75.00%)  3 0/2 (0.00%)  0 2/5 (40.00%)  2
General disorders       
Fatigue  1  0/4 (0.00%)  0 1/2 (50.00%)  1 1/5 (20.00%)  1
1
Term from vocabulary, MEDRA 10.0
2
Term from vocabulary, MedDRA 10.0
Indicates events were collected by systematic assessment
Due to the small sample size only exploratory analyses were performed.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Hans Herfarth, MD
Organization: University of North Carolina at Chapel Hill
Phone: 919-966-6806
EMail: hherf@med.unc.edu
Layout table for additonal information
Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02782325     History of Changes
Other Study ID Numbers: 16-1310
FMTADP ( Other Identifier: UNC-CH )
First Submitted: May 12, 2016
First Posted: May 25, 2016
Results First Submitted: February 18, 2019
Results First Posted: May 14, 2019
Last Update Posted: May 14, 2019