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Trial Outcomes & Findings for Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT) (NCT NCT02417974)

NCT ID: NCT02417974

Last Updated: 2022-03-24

Results Overview

Percentage of patients in each arm of the trial who develop endoscopic recurrence within 6 months of ileo-cecal resection. "Endoscopic recurrence" will be defined as a Rutgeert's score of greater than i2

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

24 participants

Primary outcome timeframe

within 6 months of ileo-cecal resection

Results posted on

2022-03-24

Participant Flow

Participant milestones

Participant milestones
Measure
Fecal Microbiota Transplant (FMT)
Fecal Microbiota Transplant (FMT) via colonoscopy Fecal Microbiota Transplant (FMT): Fecal Microbiota Transplant (FMT)
Control
No Fecal Microbiota Transplant (FMT) via colonoscopy
Overall Study
STARTED
15
9
Overall Study
COMPLETED
15
9
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Fecal Microbiota Transplant (FMT)
n=15 Participants
Fecal Microbiota Transplant (FMT) via colonoscopy Fecal Microbiota Transplant (FMT): Fecal Microbiota Transplant (FMT)
Control
n=9 Participants
No Fecal Microbiota Transplant (FMT) via colonoscopy
Total
n=24 Participants
Total of all reporting groups
Age, Continuous
39 years
STANDARD_DEVIATION 7 • n=5 Participants
46 years
STANDARD_DEVIATION 6 • n=7 Participants
41 years
STANDARD_DEVIATION 6 • n=5 Participants
Sex: Female, Male
Female
10 Participants
n=5 Participants
6 Participants
n=7 Participants
16 Participants
n=5 Participants
Sex: Female, Male
Male
5 Participants
n=5 Participants
3 Participants
n=7 Participants
8 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
15 Participants
n=5 Participants
9 Participants
n=7 Participants
24 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
White
15 Participants
n=5 Participants
9 Participants
n=7 Participants
24 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Region of Enrollment
United States
15 participants
n=5 Participants
9 participants
n=7 Participants
24 participants
n=5 Participants
Prior resection
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Smoker
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Montreal B3 classification
4 Participants
n=5 Participants
2 Participants
n=7 Participants
6 Participants
n=5 Participants

PRIMARY outcome

Timeframe: within 6 months of ileo-cecal resection

Percentage of patients in each arm of the trial who develop endoscopic recurrence within 6 months of ileo-cecal resection. "Endoscopic recurrence" will be defined as a Rutgeert's score of greater than i2

Outcome measures

Outcome measures
Measure
Fecal Microbiota Transplant (FMT)
n=15 Participants
Fecal Microbiota Transplant (FMT) via colonoscopy Fecal Microbiota Transplant (FMT): Fecal Microbiota Transplant (FMT)
Control
n=9 Participants
No Fecal Microbiota Transplant (FMT) via colonoscopy
Post-operative Endoscopic Recurrence
20 percentage of participants
0 percentage of participants

SECONDARY outcome

Timeframe: baseline, 4, 12, and 26 weeks

Population: There was insufficient data collected for any of the timeframes to calculate the Shannon Diversity Index.

The Shannon Diversity Index is a measure of entropy and is a function of the distribution of the total number of organisms across all of the species. If S is the total number of species in the sample and p\_i is the number of organisms in the i-th species divided by the total number of organisms, then Diversity = -Σ p\_i log(p\_i). Lower values indicate more diversity while higher values indicate less diversity.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 26 weeks

Clinical remission is defined as having a Harvey Bradshaw Index (HBI) score \<5 at week 26. The HBI can range from 0 to 18 and higher scores are associated with more severe disease.

Outcome measures

Outcome measures
Measure
Fecal Microbiota Transplant (FMT)
n=15 Participants
Fecal Microbiota Transplant (FMT) via colonoscopy Fecal Microbiota Transplant (FMT): Fecal Microbiota Transplant (FMT)
Control
n=9 Participants
No Fecal Microbiota Transplant (FMT) via colonoscopy
Number of Participants in Clinical Remission at 26 Weeks
14 Participants
5 Participants

SECONDARY outcome

Timeframe: 4, 12, and 26 weeks

Number of participants with adverse events

Outcome measures

Outcome measures
Measure
Fecal Microbiota Transplant (FMT)
n=15 Participants
Fecal Microbiota Transplant (FMT) via colonoscopy Fecal Microbiota Transplant (FMT): Fecal Microbiota Transplant (FMT)
Control
n=9 Participants
No Fecal Microbiota Transplant (FMT) via colonoscopy
Adverse Events Frequency
4 weeks
2 Participants
1 Participants
Adverse Events Frequency
12 weeks
0 Participants
2 Participants
Adverse Events Frequency
26 weeks
0 Participants
3 Participants

Adverse Events

Fecal Microbiota Transplant (FMT)

Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths

Control

Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Fecal Microbiota Transplant (FMT)
n=15 participants at risk
Fecal Microbiota Transplant (FMT) via colonoscopy Fecal Microbiota Transplant (FMT): Fecal Microbiota Transplant (FMT)
Control
n=9 participants at risk
No Fecal Microbiota Transplant (FMT) via colonoscopy
Gastrointestinal disorders
Hospitalization
0.00%
0/15 • 26 weeks
11.1%
1/9 • Number of events 1 • 26 weeks

Other adverse events

Other adverse events
Measure
Fecal Microbiota Transplant (FMT)
n=15 participants at risk
Fecal Microbiota Transplant (FMT) via colonoscopy Fecal Microbiota Transplant (FMT): Fecal Microbiota Transplant (FMT)
Control
n=9 participants at risk
No Fecal Microbiota Transplant (FMT) via colonoscopy
Gastrointestinal disorders
Symptoms
73.3%
11/15 • Number of events 11 • 26 weeks
66.7%
6/9 • Number of events 7 • 26 weeks

Additional Information

Alan Moss, MD, PhD

Boston Medical Center and BU School of Medicine

Phone: 617-638-6116

Results disclosure agreements

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