Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03829475 · ClinicalTrials.gov registry record · Phase 2
ICON-2: FMT and Bezlotoxumab Compared to FMT and Placebo for Patients With IBD and CDI
A Phase 2 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 61
- Enrollment target
NCT03829475: Completed Phase 2 study, sponsored by Brigham and Women's Hospital.
NCT03829475 is a Phase 2 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 61 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03829475, a Phase 2 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 61 participants
- Enrollment target
Study Summary
This is a randomized controlled trial to assess the clinical and microbiological impacts of FMT in combination with Bezlotoxumab (bezlo) compared to FMT in combination with placebo in patients with both inflammatory bowel disease (IBD) a and clostridium difficile infection (CDI). The investigators will prospectively enroll up to 150 IBD-CDI patients from 4 tertiary care FMT referral centers. Patients will be randomized 1:1 to either receive FMT in combination with Bezlo of FMT and a placebo infusion. Donor stool from healthy donors will be obtained from OpenBiome. OpenBiome is a nonprofit 501(c)(3) organization that provides hospitals with screened, filtered, and frozen material ready for clinical use. Patients will be enrolled and followed prospectively for 3 months post therapy. Stool and blood samples as well as clinical data will be collected at baseline, week 1, 8 and 12.
Primary Outcome
positive test for CDI by EIA toxin
Interventions
- DRUG Placebo
- DRUG Fecal Microbiota Transplantation
- DRUG Bezlotoxumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2020-01-01 |
| Est. Completion | 2025-06-01 |
| Phase | Phase 2 |
What the finished NCT03829475 record still lists
NCT03829475 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03829475 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03829475 about?
NCT03829475 is a clinical study titled "ICON-2: FMT and Bezlotoxumab Compared to FMT and Placebo for Patients With IBD and CDI". This is a randomized controlled trial to assess the clinical and microbiological impacts of FMT in combination with Bezlotoxumab (bezlo) compared to FMT in combination with placebo in patients with both inflammatory bowel disease (IBD) a and clostridium difficile infection (CDI). The investigators w...
What is the current status of trial NCT03829475?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2020-01-01. Estimated completion is 2025-06-01.
What interventions are being tested in trial NCT03829475?
The interventions under investigation include: Placebo (DRUG), Fecal Microbiota Transplantation (DRUG), Bezlotoxumab (DRUG).
Who is sponsoring clinical trial NCT03829475?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03829475's enrollment target sits among peer trials
61 1026th of 2000 higher than 974 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04115306 · 61 participants · Phase 1
Phase 1/1b/2 Study of Oral PMD-026 in Patients With Metastatic Breast Cancer
- NCT05070845 · 61 participants · Phase 2
Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia
- NCT05187832 · 61 participants · Phase 1
A Study of AND019 in Women With ER Positive HER2 Negative Advanced or Metastatic Breast Cancer
- NCT05269316 · 61 participants · Phase 1
Study to Evaluate IMP9064 as a Monotherapy or in Combination in Patients With Advanced Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI