Trial Outcomes & Findings for The ICON Study: Outcomes After FMT for Patients With IBD and CDI (NCT NCT03106844)

NCT ID: NCT03106844

Last Updated: 2021-02-10

Results Overview

Recurrence of c.diffile infection

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 50 participants
• Primary outcome timeframe: 8 weeks
• Results posted on: 2021-02-10

Participant Flow

Participant milestones

Measure	Treatment All patients in this study will receive Fecal Microbiota Tranplantation Fecal Microbiota Transplantation: Patients with at least 2 episodes of CDI and IBD will undergo a single FMT
Overall Study STARTED	50
Overall Study COMPLETED	49
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The ICON Study: Outcomes After FMT for Patients With IBD and CDI

Baseline characteristics by cohort

Measure	Treatment n=50 Participants All patients in this study will receive Fecal Microbiota Tranplantation Fecal Microbiota Transplantation: Patients with at least 2 episodes of CDI and IBD will undergo a single FMT
Age, Continuous	43 years n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	47 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Baseline Calprotectin	5.3 mg/L STANDARD_DEVIATION 8.7 • n=5 Participants
Baseline C-Reactive Protein	1919.6 ug/g STANDARD_DEVIATION 2432.3 • n=5 Participants
Average Bowel Movements	5.2 bowel movements STANDARD_DEVIATION 4.0 • n=5 Participants
Average Bristol Score	5.6 units on a scale STANDARD_DEVIATION 1.1 • n=5 Participants
Average Complete Mayo	5.6 units on a scale STANDARD_DEVIATION 3.3 • n=5 Participants
Average Partial Mayo	4.2 units on a scale STANDARD_DEVIATION 2.1 • n=5 Participants
Average Harvey Bradshaw Index	5.8 units on a scale STANDARD_DEVIATION 3.4 • n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Recurrence of c.diffile infection

Outcome measures

Measure	Treatment n=49 Participants All patients in this study will receive Fecal Microbiota Tranplantation Fecal Microbiota Transplantation: Patients with at least 2 episodes of CDI and IBD will undergo a single FMT
Number of Participants With FMT Failure	4 Participants

SECONDARY outcome

Timeframe: 8 weeks

asymptomatic patients with positive stool testing for c.difficile via polymerase chain reaction testing

Outcome measures

Measure	Treatment n=49 Participants All patients in this study will receive Fecal Microbiota Tranplantation Fecal Microbiota Transplantation: Patients with at least 2 episodes of CDI and IBD will undergo a single FMT
Participants Colonized With C.Difficile	5 Participants

Adverse Events

Treatment

Serious events: 3 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment n=50 participants at risk All patients in this study will receive Fecal Microbiota Tranplantation Fecal Microbiota Transplantation: Patients with at least 2 episodes of CDI and IBD will undergo a single FMT
Blood and lymphatic system disorders Anemia	2.0% 1/50 • Number of events 1 • Adverse event data was collected through week 26 (6 months)
Gastrointestinal disorders IBD Flare	2.0% 1/50 • Number of events 1 • Adverse event data was collected through week 26 (6 months)

Other adverse events

Measure	Treatment n=50 participants at risk All patients in this study will receive Fecal Microbiota Tranplantation Fecal Microbiota Transplantation: Patients with at least 2 episodes of CDI and IBD will undergo a single FMT
Gastrointestinal disorders Diarrhea	44.0% 22/50 • Adverse event data was collected through week 26 (6 months)
Gastrointestinal disorders Rectal Bleeding	16.0% 8/50 • Adverse event data was collected through week 26 (6 months)
Gastrointestinal disorders Abdominal Pain	26.0% 13/50 • Adverse event data was collected through week 26 (6 months)
Gastrointestinal disorders Nausea	10.0% 5/50 • Adverse event data was collected through week 26 (6 months)
Gastrointestinal disorders Vomiting	6.0% 3/50 • Adverse event data was collected through week 26 (6 months)
General disorders Fever	10.0% 5/50 • Adverse event data was collected through week 26 (6 months)
General disorders Fatigue	6.0% 3/50 • Adverse event data was collected through week 26 (6 months)
Gastrointestinal disorders Heart Burn	4.0% 2/50 • Adverse event data was collected through week 26 (6 months)
General disorders Chills	4.0% 2/50 • Adverse event data was collected through week 26 (6 months)
Nervous system disorders Migraine	4.0% 2/50 • Adverse event data was collected through week 26 (6 months)
Renal and urinary disorders Yeast Infection	4.0% 2/50 • Adverse event data was collected through week 26 (6 months)
Gastrointestinal disorders Constiption	12.0% 6/50 • Adverse event data was collected through week 26 (6 months)

Additional Information

Jessica Allegretti MD MPH

Brigham and Women's Hospital

Phone: 617-525-7322

Email: jallegretti@bwh.harvard.edu

Results disclosure agreements

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