Trial Outcomes & Findings for Lyophilized Fecal Microbiota Transplantation for Recurrent Clostridioides Difficile Infection (NCT NCT03834038)

Results Overview

No recurrence of CDI-related diarrhea at 13 weeks following last FMT without the need for an intervention antibiotics or additional FMT specifically for CDI recurrence.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

158 participants

Primary outcome timeframe

13 weeks from last FMT

Results posted on

2024-09-23

Participant Flow

Participants must have laboratory or pathology-confirmed diagnosis of recurrent CDI based on Society for Healthcare epidemiology of America SHEA 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 oral course of Vancomycin Eligible participants at time of screening will discontinue antibiotic 24-48 hours prior to scheduled FMT

Participant milestones

Participant milestones
Measure	Open Label Lyophilized Fecal Microbiota Transplantation Open label for eligible participants with history of recurrent or refractory CDI Evaluate treatment efficacy as determined by no recurrence of CDI-related diarrhea at 13 weeks after receiving up to 2 lyophilized FMTs without the need for an intervention (antibiotics or frozen or lyophilized FMT as per investigator's decision) specifically for recurrence of CDI.
Overall Study STARTED	158
Overall Study Completion of 2-year Follow-up	132
Overall Study COMPLETED	132
Overall Study NOT COMPLETED	26

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open Label Lyophilized Fecal Microbiota Transplantation n=158 Participants Eligible participants with history of recurrent or refractory CDI Lyophilized Fecal Microbiota Transplantation: Lyophilized FMT
Age, Continuous	70.25 years STANDARD_DEVIATION 17.27 • n=158 Participants
Sex: Female, Male Female	97 Participants n=158 Participants
Sex: Female, Male Male	61 Participants n=158 Participants

PRIMARY outcome

Timeframe: 13 weeks from last FMT

Population: 140 included in per-protocol analysis for primary endpoint 18 excluded as died/withdrew before week 13

No recurrence of CDI-related diarrhea at 13 weeks following last FMT without the need for an intervention antibiotics or additional FMT specifically for CDI recurrence.

Outcome measures

Outcome measures
Measure	Open Label Lyophilized Fecal Microbiota Transplantation n=140 Participants Eligible participants treated with LYO-FMT Evaluate treatment efficacy as determined by no recurrence of CDI-related diarrhea at 13 weeks after receiving up to 2 lyophilized FMTs without the need for an intervention (antibiotics or frozen or lyophilized FMT as per investigator's decision) specifically for recurrence of CDI.
No Recurrence of CDI-related Diarrhea at 13 Weeks From Last LYO-FMT	106 participants

Adverse Events

Open Label Lyophilized Fecal Microbiota Transplantation

Serious events: 14 serious events

Other events: 15 other events

Deaths: 10 deaths

Serious adverse events

Serious adverse events
Measure	Open Label Lyophilized Fecal Microbiota Transplantation n=158 participants at risk Open label for eligible participants with history of recurrent or refractory CDI Evaluate treatment efficacy as determined by no recurrence of CDI-related diarrhea at 13 weeks after receiving up to 2 lyophilized FMTs without the need for an intervention (antibiotics or frozen or lyophilized FMT as per investigator's decision) specifically for recurrence of CDI.
Cardiac disorders Cardiac event	2.5% 4/158 • Number of events 4 • 1 year 2 months
Renal and urinary disorders Genitourinary dysfunction	0.63% 1/158 • Number of events 1 • 1 year 2 months
Infections and infestations C. difficile infection	1.9% 3/158 • Number of events 3 • 1 year 2 months
Blood and lymphatic system disorders leukocytosis	1.3% 2/158 • Number of events 2 • 1 year 2 months
Injury, poisoning and procedural complications Falls	1.3% 2/158 • Number of events 2 • 1 year 2 months
Respiratory, thoracic and mediastinal disorders Respiratory disorder	1.3% 2/158 • Number of events 2 • 1 year 2 months

Other adverse events

Other adverse events
Measure	Open Label Lyophilized Fecal Microbiota Transplantation n=158 participants at risk Open label for eligible participants with history of recurrent or refractory CDI Evaluate treatment efficacy as determined by no recurrence of CDI-related diarrhea at 13 weeks after receiving up to 2 lyophilized FMTs without the need for an intervention (antibiotics or frozen or lyophilized FMT as per investigator's decision) specifically for recurrence of CDI.
Gastrointestinal disorders Common Non-Serious	9.5% 15/158 • Number of events 15 • 1 year 2 months

Additional Information

Dr. Christine Lee

Vancouver Island Health Authority

Phone: 250-519-1898

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place