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A Prospective Trial of Frozen-and-Thawed Fecal Microbiota Transplantation for Recurrent Clostridium Difficile Infection

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ClinicalTrials.gov Identifier: NCT02394275
Recruitment Status : Terminated (Lack of funding for long-term follow-up)
First Posted : March 20, 2015
Results First Posted : October 26, 2021
Last Update Posted : October 26, 2021
Sponsor:
Collaborator:
St. Joseph's Healthcare Hamilton
Information provided by (Responsible Party):
McMaster University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Clostridium Difficile
Intervention Biological: Fecal Microbiota Transplant
Enrollment 140
Recruitment Details  
Pre-assignment Details

Participants must have laboratory diagnosis of recurrent CDI based on Society for Healthcare Epidemiology of America definition, recurrence defined as return of diarrhea and positive stool test after period of symptom resolution within 8 weeks of the first episode and has received at least 10-day course of oral vancomycin.

Eligible participants at time of screening will discontinue antibiotic 24 to 48 hours prior to receiving FMT
Arm/Group Title Single Arm:
Hide Arm/Group Description

Eligible patients with receive intervention: frozen fecal microbiota transplantation (FMT), kept at -20 oC and will be thawed prior to administration. Patients on antibiotic to control CDI will discontinue antibiotic 24 hours prior to FMT.

Fecal Microbiota Transplant: All eligible patients will receive fecal microbiota transplant
Period Title: Overall Study
Started 140
Safety Population 133
Evaluable at 13 Weeks 133
Completed 111
Not Completed 29
Reason Not Completed
Adverse Event             22
Lost to Follow-up             7
Arm/Group Title Single Arm:
Hide Arm/Group Description

Eligible patients with receive intervention: frozen fecal microbiota transplantation (FMT), kept at -20 oC and will be thawed prior to administration. Patients on antibiotic to control CDI will discontinue antibiotic 24 hours prior to FMT.

Fecal Microbiota Transplant: All eligible patients will receive fecal microbiota transplant
Overall Number of Baseline Participants 140
Hide Baseline Analysis Population Description
18 years or older with a history of recurrent CDI
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 140 participants
71.3  (16.33)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 140 participants
Female
89
  63.6%
Male
51
  36.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 140 participants
140
1.Primary Outcome
Title No Recurrence of CDI-related Diarrhea
Hide Description No recurrence of CDI-related diarrhea at 8 weeks following last FMT without the need for an intervention (antibiotics or additional FMT) specifically for recurrence of CDI
Time Frame 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Single Arm:
Hide Arm/Group Description:

Eligible patients with receive intervention: frozen fecal microbiota transplantation (FMT), kept at -20 oC and will be thawed prior to administration.

Participants on antibiotic to control CDI will discontinue antibiotic 24 - 48 hours hours prior to FMT.

Fecal Microbiota Transplant: All eligible patients will receive fecal microbiota transplant
Overall Number of Participants Analyzed 133
Measure Type: Number
Unit of Measure: participants
FMT open-label 133
Treatment Success 119
2.Secondary Outcome
Title Safety of FMT
Hide Description

Evaluate safety of FMT for any serious adverse events up to and including week 13 of receiving FMT for any of the following:

  • Death or a life-threatening event
  • Hospitalization or prolongation of current hospitalization
  • A significant new incapacity to conduct normal life functions
Time Frame 13 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FMT Open-label
Hide Arm/Group Description:

Eligible patients received intervention: frozen fecal microbiota transplantation (FMT), kept at -20 oC and thawed prior to administration. Patients on antibiotic to control CDI will discontinue antibiotic 24 hours prior to FMT.

Fecal Microbiota Transplant: All eligible patients received fecal microbiota transplant
Overall Number of Participants Analyzed 133
Measure Type: Count of Participants
Unit of Measure: Participants
All cause mortality
11
   8.3%
SAE due to cardiac cause
4
   3.0%
SAE due to GI cause
3
   2.3%
SAE due to Infections (recurrent C. difficile)
5
   3.8%
SAE due to renal cause
2
   1.5%
SAE due to respiratory cause
2
   1.5%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Single Arm:
Hide Arm/Group Description

Eligible patients with receive intervention: frozen fecal microbiota transplantation (FMT), kept at -20 oC and will be thawed prior to administration. Patients on antibiotic to control CDI will discontinue antibiotic 24 hours prior to FMT.

Fecal Microbiota Transplant: All eligible patients will receive fecal microbiota transplant
All-Cause Mortality
Single Arm:
Affected / at Risk (%)
Total   11/133 (8.27%) 
Hide Serious Adverse Events
Single Arm:
Affected / at Risk (%)
Total   16/133 (12.03%) 
Cardiac disorders   
Congestive heart failure *  2/133 (1.50%) 
Arrhythmia *  1/133 (0.75%) 
Coronary artery disease *  1/133 (0.75%) 
Infections and infestations   
Urinary tract infection *  4/133 (3.01%) 
Bacteremia *  1/133 (0.75%) 
Clostridium difficile infection *  3/133 (2.26%) 
Renal and urinary disorders   
Acute kidney injury *  2/133 (1.50%) 
Respiratory, thoracic and mediastinal disorders   
pneumonia *  2/133 (1.50%) 
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Single Arm:
Affected / at Risk (%)
Total   11/133 (8.27%) 
Gastrointestinal disorders   
Gastrointestinal disorders * [1]  11/133 (8.27%) 
*
Indicates events were collected by non-systematic assessment
[1]
abdominal cramps, loose bowel movements
[Not Specified]
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: Dr. Marek Smieja
Organization: St. Joseph's Healthcare Hamilton, ON
Phone: 905 521 6021
EMail: smiejam@mcmaster.ca
Layout table for additonal information
Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT02394275    
Other Study ID Numbers: CDI.FMT.2
First Submitted: March 10, 2015
First Posted: March 20, 2015
Results First Submitted: June 2, 2021
Results First Posted: October 26, 2021
Last Update Posted: October 26, 2021