Trial Outcomes & Findings for ICON-2: FMT and Bezlotoxumab Compared to FMT and Placebo for Patients With IBD and CDI (NCT NCT03829475)
NCT ID: NCT03829475
Last Updated: 2025-12-09
Results Overview
positive test for CDI by EIA toxin
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
61 participants
Primary outcome timeframe
8 weeks
Results posted on
2025-12-09
Participant Flow
Participant milestones
| Measure |
FMT + Bezlo
Participants received an FMT via colonoscopy (250ml) as well as a single IV infusion of bezlotoxumab (10mg/kg) that took place over 60 minutes.
Bezlotoxumab: This is a a fully human monoclonal antibody that binds to C. difficile toxin B, and is indicated to prevent recurrence of CDI in adults at risk for recurrent CDI (rCDI).
Fecal Microbiota Transplantation: FMT is an infusion of prescreened donor stool that will be administered via colonoscopy
|
FMT + Placebo
Participants received a single FMT via colonoscopy (250ml) and a placebo (saline) infusion (250cc) over 60 minutes.
Placebo: placebo is an infusion of normal saline.
Fecal Microbiota Transplantation: FMT is an infusion of prescreened donor stool that will be administered via colonoscopy
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
31
|
|
Overall Study
COMPLETED
|
30
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Partial Mayo only applies to subjects with Ulcerative Colitis
Baseline characteristics by cohort
| Measure |
FMT + Bezlo
n=30 Participants
Participants received an FMT via colonoscopy (250ml) as well as a single IV infusion of bezlotoxumab (10mg/kg) that took place over 60 minutes.
Bezlotoxumab: This is a a fully human monoclonal antibody that binds to C. difficile toxin B, and is indicated to prevent recurrence of CDI in adults at risk for recurrent CDI (rCDI).
Fecal Microbiota Transplantation: FMT is an infusion of prescreened donor stool that will be administered via colonoscopy
|
FMT + Placebo
n=31 Participants
Participants received a single FMT via colonoscopy (250ml) and a placebo (saline) infusion (250cc) over 60 minutes.
Placebo: placebo is an infusion of normal saline.
Fecal Microbiota Transplantation: FMT is an infusion of prescreened donor stool that will be administered via colonoscopy
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.5 years
n=30 Participants
|
34 years
n=31 Participants
|
38 years
n=61 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=30 Participants
|
14 Participants
n=31 Participants
|
28 Participants
n=61 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=30 Participants
|
17 Participants
n=31 Participants
|
33 Participants
n=61 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=30 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=61 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=30 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=61 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=61 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=30 Participants
|
1 Participants
n=31 Participants
|
3 Participants
n=61 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=30 Participants
|
27 Participants
n=31 Participants
|
54 Participants
n=61 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=30 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=61 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=30 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=61 Participants
|
|
Baseline Calprotectin
|
930.5 mcg/g
n=30 Participants
|
241 mcg/g
n=31 Participants
|
635 mcg/g
n=61 Participants
|
|
Baseline Bowel Movement
|
5 bowel movements
n=30 Participants
|
4 bowel movements
n=31 Participants
|
5 bowel movements
n=61 Participants
|
|
Baseline Bristol Score
|
5 units on a scale
n=30 Participants
|
5 units on a scale
n=31 Participants
|
5 units on a scale
n=61 Participants
|
|
Baseline Partial Mayo
|
3.5 units on a scale
n=24 Participants • Partial Mayo only applies to subjects with Ulcerative Colitis
|
2 units on a scale
n=17 Participants • Partial Mayo only applies to subjects with Ulcerative Colitis
|
3 units on a scale
n=41 Participants • Partial Mayo only applies to subjects with Ulcerative Colitis
|
|
Baseline Harvey Bradshaw Index
|
7 units on a scale
n=6 Participants • HBI only applies to subjects with Crohn's Disease
|
6.5 units on a scale
n=14 Participants • HBI only applies to subjects with Crohn's Disease
|
6.5 units on a scale
n=20 Participants • HBI only applies to subjects with Crohn's Disease
|
PRIMARY outcome
Timeframe: 8 weekspositive test for CDI by EIA toxin
Outcome measures
| Measure |
FMT + Bezlo
n=30 Participants
Participants received an FMT via colonoscopy (250ml) as well as a single IV infusion of bezlotoxumab (10mg/kg) that took place over 60 minutes.
Bezlotoxumab: This is a a fully human monoclonal antibody that binds to C. difficile toxin B, and is indicated to prevent recurrence of CDI in adults at risk for recurrent CDI (rCDI).
Fecal Microbiota Transplantation: FMT is an infusion of prescreened donor stool that will be administered via colonoscopy
|
FMT + Placebo
n=31 Participants
Participants received a single FMT via colonoscopy (250ml) and a placebo (saline) infusion (250cc) over 60 minutes.
Placebo: placebo is an infusion of normal saline.
Fecal Microbiota Transplantation: FMT is an infusion of prescreened donor stool that will be administered via colonoscopy
|
|---|---|---|
|
Number of Participants With Clostridium Difficile Recurrence
|
4 Participants
|
1 Participants
|
Adverse Events
FMT + Bezlo
Serious events: 5 serious events
Other events: 16 other events
Deaths: 0 deaths
FMT + Placebo
Serious events: 4 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
FMT + Bezlo
n=30 participants at risk
Participants received an FMT via colonoscopy (250ml) as well as a single IV infusion of bezlotoxumab (10mg/kg) that took place over 60 minutes.
Bezlotoxumab: This is a a fully human monoclonal antibody that binds to C. difficile toxin B, and is indicated to prevent recurrence of CDI in adults at risk for recurrent CDI (rCDI).
Fecal Microbiota Transplantation: FMT is an infusion of prescreened donor stool that will be administered via colonoscopy
|
FMT + Placebo
n=31 participants at risk
Participants received a single FMT via colonoscopy (250ml) and a placebo (saline) infusion (250cc) over 60 minutes.
Placebo: placebo is an infusion of normal saline.
Fecal Microbiota Transplantation: FMT is an infusion of prescreened donor stool that will be administered via colonoscopy
|
|---|---|---|
|
Gastrointestinal disorders
IBD Flare
|
3.3%
1/30 • Number of events 1 • Adverse event data was collected through Week 26 (6 months).
|
0.00%
0/31 • Adverse event data was collected through Week 26 (6 months).
|
|
Gastrointestinal disorders
Colectomy
|
3.3%
1/30 • Number of events 1 • Adverse event data was collected through Week 26 (6 months).
|
0.00%
0/31 • Adverse event data was collected through Week 26 (6 months).
|
|
Gastrointestinal disorders
Hospitalization
|
3.3%
1/30 • Number of events 1 • Adverse event data was collected through Week 26 (6 months).
|
0.00%
0/31 • Adverse event data was collected through Week 26 (6 months).
|
|
Gastrointestinal disorders
IBD flare
|
3.3%
1/30 • Number of events 1 • Adverse event data was collected through Week 26 (6 months).
|
0.00%
0/31 • Adverse event data was collected through Week 26 (6 months).
|
Other adverse events
| Measure |
FMT + Bezlo
n=30 participants at risk
Participants received an FMT via colonoscopy (250ml) as well as a single IV infusion of bezlotoxumab (10mg/kg) that took place over 60 minutes.
Bezlotoxumab: This is a a fully human monoclonal antibody that binds to C. difficile toxin B, and is indicated to prevent recurrence of CDI in adults at risk for recurrent CDI (rCDI).
Fecal Microbiota Transplantation: FMT is an infusion of prescreened donor stool that will be administered via colonoscopy
|
FMT + Placebo
n=31 participants at risk
Participants received a single FMT via colonoscopy (250ml) and a placebo (saline) infusion (250cc) over 60 minutes.
Placebo: placebo is an infusion of normal saline.
Fecal Microbiota Transplantation: FMT is an infusion of prescreened donor stool that will be administered via colonoscopy
|
|---|---|---|
|
Gastrointestinal disorders
Fecal urgency
|
3.3%
1/30 • Adverse event data was collected through Week 26 (6 months).
|
0.00%
0/31 • Adverse event data was collected through Week 26 (6 months).
|
|
Gastrointestinal disorders
Flatulence
|
3.3%
1/30 • Adverse event data was collected through Week 26 (6 months).
|
3.2%
1/31 • Adverse event data was collected through Week 26 (6 months).
|
|
Metabolism and nutrition disorders
Anorexia
|
3.3%
1/30 • Adverse event data was collected through Week 26 (6 months).
|
0.00%
0/31 • Adverse event data was collected through Week 26 (6 months).
|
|
Injury, poisoning and procedural complications
Dermatitis Radiation
|
3.3%
1/30 • Adverse event data was collected through Week 26 (6 months).
|
0.00%
0/31 • Adverse event data was collected through Week 26 (6 months).
|
|
Renal and urinary disorders
Urinary incontinence
|
3.3%
1/30 • Adverse event data was collected through Week 26 (6 months).
|
0.00%
0/31 • Adverse event data was collected through Week 26 (6 months).
|
|
Infections and infestations
Herpes Simplex Reactivation
|
0.00%
0/30 • Adverse event data was collected through Week 26 (6 months).
|
3.2%
1/31 • Adverse event data was collected through Week 26 (6 months).
|
|
Vascular disorders
Flushing
|
0.00%
0/30 • Adverse event data was collected through Week 26 (6 months).
|
3.2%
1/31 • Adverse event data was collected through Week 26 (6 months).
|
|
Gastrointestinal disorders
Bloating
|
0.00%
0/30 • Adverse event data was collected through Week 26 (6 months).
|
3.2%
1/31 • Adverse event data was collected through Week 26 (6 months).
|
|
Immune system disorders
Allergic reaction
|
3.3%
1/30 • Adverse event data was collected through Week 26 (6 months).
|
0.00%
0/31 • Adverse event data was collected through Week 26 (6 months).
|
|
Vascular disorders
Thrombocytopenia
|
0.00%
0/30 • Adverse event data was collected through Week 26 (6 months).
|
3.2%
1/31 • Adverse event data was collected through Week 26 (6 months).
|
|
General disorders
COVID-19 Infection
|
3.3%
1/30 • Adverse event data was collected through Week 26 (6 months).
|
0.00%
0/31 • Adverse event data was collected through Week 26 (6 months).
|
|
Gastrointestinal disorders
Diarrhea
|
26.7%
8/30 • Adverse event data was collected through Week 26 (6 months).
|
22.6%
7/31 • Adverse event data was collected through Week 26 (6 months).
|
|
Gastrointestinal disorders
Rectal Bleeding
|
3.3%
1/30 • Adverse event data was collected through Week 26 (6 months).
|
0.00%
0/31 • Adverse event data was collected through Week 26 (6 months).
|
|
Gastrointestinal disorders
Abdominal Pain
|
23.3%
7/30 • Adverse event data was collected through Week 26 (6 months).
|
19.4%
6/31 • Adverse event data was collected through Week 26 (6 months).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/30 • Adverse event data was collected through Week 26 (6 months).
|
3.2%
1/31 • Adverse event data was collected through Week 26 (6 months).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/30 • Adverse event data was collected through Week 26 (6 months).
|
6.5%
2/31 • Adverse event data was collected through Week 26 (6 months).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/30 • Adverse event data was collected through Week 26 (6 months).
|
3.2%
1/31 • Adverse event data was collected through Week 26 (6 months).
|
|
Skin and subcutaneous tissue disorders
Chest Rash
|
0.00%
0/30 • Adverse event data was collected through Week 26 (6 months).
|
3.2%
1/31 • Adverse event data was collected through Week 26 (6 months).
|
|
General disorders
Fatigue
|
6.7%
2/30 • Adverse event data was collected through Week 26 (6 months).
|
3.2%
1/31 • Adverse event data was collected through Week 26 (6 months).
|
|
General disorders
Headache
|
3.3%
1/30 • Adverse event data was collected through Week 26 (6 months).
|
3.2%
1/31 • Adverse event data was collected through Week 26 (6 months).
|
|
General disorders
Fever
|
3.3%
1/30 • Adverse event data was collected through Week 26 (6 months).
|
3.2%
1/31 • Adverse event data was collected through Week 26 (6 months).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place