Trial Outcomes & Findings for A Prospective Trial of Frozen-and-Thawed Fecal Microbiota Transplantation for Recurrent Clostridium Difficile Infection (NCT NCT02394275)

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

140 participants

Primary outcome timeframe

13 weeks

Results posted on

2021-10-26

Participant Flow

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

Participant milestones

Participant milestones
Measure	Single Arm: 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 Study STARTED	140
Overall Study Safety Population	133
Overall Study Evaluable at 13 Weeks	133
Overall Study COMPLETED	111
Overall Study NOT COMPLETED	29

Reasons for withdrawal

Reasons for withdrawal
Measure	Single Arm: 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 Study Adverse Event	22
Overall Study Lost to Follow-up	7

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm: n=140 Participants 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
Age, Continuous	71.3 years STANDARD_DEVIATION 16.33 • n=5 Participants
Sex: Female, Male Female	89 Participants n=5 Participants
Sex: Female, Male Male	51 Participants n=5 Participants
Region of Enrollment Canada	140 participants n=5 Participants

PRIMARY outcome

Timeframe: 13 weeks

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

Outcome measures

Outcome measures
Measure	Single Arm: n=133 Participants 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
No Recurrence of CDI-related Diarrhea FMT open-label	133 participants
No Recurrence of CDI-related Diarrhea Treatment Success	119 participants

SECONDARY outcome

Timeframe: 13 weeks

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

Outcome measures

Outcome measures
Measure	Single Arm: n=133 Participants 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
Safety of FMT All cause mortality	11 Participants
Safety of FMT SAE due to cardiac cause	4 Participants
Safety of FMT SAE due to GI cause	3 Participants
Safety of FMT SAE due to Infections (recurrent C. difficile)	5 Participants
Safety of FMT SAE due to renal cause	2 Participants
Safety of FMT SAE due to respiratory cause	2 Participants

Adverse Events

Single Arm:

Serious events: 16 serious events

Other events: 11 other events

Deaths: 11 deaths

Serious adverse events

Serious adverse events
Measure	Single Arm: n=133 participants at risk 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
Infections and infestations Urinary tract infection	3.0% 4/133
Cardiac disorders Congestive heart failure	1.5% 2/133
Renal and urinary disorders Acute kidney injury	1.5% 2/133
Respiratory, thoracic and mediastinal disorders pneumonia	1.5% 2/133
Cardiac disorders Arrhythmia	0.75% 1/133
Cardiac disorders Coronary artery disease	0.75% 1/133
Infections and infestations Bacteremia	0.75% 1/133
Infections and infestations Clostridium difficile infection	2.3% 3/133

Other adverse events

Other adverse events
Measure	Single Arm: n=133 participants at risk 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
Gastrointestinal disorders Gastrointestinal disorders	8.3% 11/133

Additional Information

Dr. Marek Smieja

St. Joseph's Healthcare Hamilton, ON

Phone: 905 521 6021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place