Trial Outcomes & Findings for Efficacy and Safety of Fecal Microbiota Transplantation for Severe Clostridium Difficile Associated Colitis (NCT NCT01959048)

NCT ID: NCT01959048

Last Updated: 2019-08-21

Results Overview

Resolution of diarrhea, time to decrease in elevated WBC count

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 3 participants
• Primary outcome timeframe: 2 weeks
• Results posted on: 2019-08-21

Participant Flow

Participant milestones

Measure	Fecal Microbiota Transplant fecal microbiota transplantation fecal microbiota transplantation
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Fecal Microbiota Transplant n=3 Participants fecal microbiota transplantation fecal microbiota transplantation
Age, Categorical <=18 years	0 Participants n=3 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=3 Participants
Age, Categorical >=65 years	3 Participants n=3 Participants
Age, Continuous	78 years n=3 Participants
Sex: Female, Male Female	2 Participants n=3 Participants
Sex: Female, Male Male	1 Participants n=3 Participants
Region of Enrollment Israel	3 participants n=3 Participants

PRIMARY outcome

Timeframe: 2 weeks

Resolution of diarrhea, time to decrease in elevated WBC count

Outcome measures

Measure	Fecal Microbiota Transplant n=3 Participants fecal microbiota transplantation fecal microbiota transplantation
Number of Participants With Resolution of Severe CDAD	3 participants

PRIMARY outcome

Timeframe: 2 weeks

Number of Participants with evidence of relapse of C. diff. associated diarrhea

Outcome measures

Measure	Fecal Microbiota Transplant n=3 Participants fecal microbiota transplantation fecal microbiota transplantation
Number of Participants With Relapse of CDAD	3 Participants

SECONDARY outcome

Timeframe: 30 days

Outcome measures

Measure	Fecal Microbiota Transplant n=3 Participants fecal microbiota transplantation fecal microbiota transplantation
All Cause Mortality	1 Participants

SECONDARY outcome

Timeframe: 30 days

Number of Participants who undergo colectomy due to CDAD

Outcome measures

Measure	Fecal Microbiota Transplant n=3 Participants fecal microbiota transplantation fecal microbiota transplantation
Need for Colectomy	0 Participants

SECONDARY outcome

Timeframe: 1 weeks

immediate colonoscopy-related complications, secondary infection

Outcome measures

Measure	Fecal Microbiota Transplant n=3 Participants fecal microbiota transplantation fecal microbiota transplantation
Morbidity	0 Participants

Adverse Events

Fecal Microbiota Transplant

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Fecal Microbiota Transplant n=3 participants at risk fecal microbiota transplantation fecal microbiota transplantation
Musculoskeletal and connective tissue disorders Death	33.3% 1/3 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Jacob Strahilevitz

Hadassah-Hebrew University

Phone: 972508946353

Email: jstrahilevitz@hadassah.org.il

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place