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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FMT + Bezlo | Experimental | Patients in this arm will received an FMT via colonoscopy ( 250ml) as well as a single IV infusion of bezlotoxumab (10mg/kg) that will take place over 60 mins. |
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| FMT + Placebo | Placebo Comparator | Patients in this arm will receive a single FMT via colonoscopy (250ml) and a placebo (saline) infusion (250cc) over |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bezlotoxumab | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clostridium Difficile Recurrence | positive test for CDI by EIA toxin | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Clostridium Difficile Recurrence | positive test for CDI by EIA toxin | Posted | Count of Participants | Participants | 8 weeks |
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Adverse event data was collected through Week 26 (6 months).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| IBD Flare | Gastrointestinal disorders | Non-systematic Assessment | Subject was hospitalized due to a UC flare, the study team determined it not to be related to FMT procedure. The adverse event resolved, and the subject continued in the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
This study was limited by the sample size as well as the inclusion of PCR only testing for the qualifying episode. .
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessica Allegretti MD MPH | Brigham and Women's Hospital | 617-525-7322 | jallegretti@bwh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 10, 2022 | Aug 13, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003015 | Clostridium Infections |
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| C000613978 | bezlotoxumab |
| D012965 | Sodium Chloride |
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Placebo | Drug | placebo is an infusion of normal saline. |
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| Fecal Microbiota Transplantation | Drug | FMT is an infusion of prescreened donor stool that will be administered via colonoscopy |
|
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| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Baseline Calprotectin | Median | Inter-Quartile Range | mcg/g |
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| Baseline Bowel Movement | This is based on symptoms experienced in the 3 days preceding the baseline study visit. | Median | Inter-Quartile Range | bowel movements |
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| Baseline Bristol Score | Range 1-7. Low scores represent hard stools and high numbers represent liquid stools | Median | Inter-Quartile Range | units on a scale |
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| Baseline Partial Mayo | Range 0-9. The score is a ulcerative colitis disease activity assessment and has 3 components: bowel movements, rectal bleeding, and physical global assessment. Each component ranges from 0-3. The scores from each subsection are added together to get the total score. Low scores indicate inactive disease. High scores indicate active disease. | Partial Mayo only applies to subjects with Ulcerative Colitis | Median | Inter-Quartile Range | units on a scale |
|
| Baseline Harvey Bradshaw Index | This is a disease activity index for Crohn's disease. Components include: general well being [score 0-4] abdominal pain [score 0-3], number of liquid stools, abdominal mass [score 0-3], and complications of disease [score 0-8]. The score if each component is added together to get the total score [Range 0 to 18] The upper range is open ended as the number of liquid stools will vary by patient. HBI < 5 is defined as clinical remission, HBI between 5 and 7 as mild disease, HBI between 8 and 16 as moderate disease, and HBI > 16 as severe disease. | HBI only applies to subjects with Crohn's Disease | Median | Inter-Quartile Range | units on a scale |
|
|
|
|
| 0 |
| 30 |
| 5 |
| 30 |
| 16 |
| 30 |
| EG001 | 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 | 0 | 31 | 4 | 31 | 15 | 31 |
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| IBD Flare | Gastrointestinal disorders | Non-systematic Assessment | Subject was hospitalized due to a UC flare causing abdominal pain, the subject was discontinued from the trial prior to receiving study drug. |
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| Colectomy | Gastrointestinal disorders | Non-systematic Assessment | Subject was admitted due to IBD complications, and surgical laparoscopy with complete colectomy and ileostomy by abdominal approach was performed. Post-op was uncomplicated, and subject was discharged. |
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| IBD Flare | Gastrointestinal disorders | Non-systematic Assessment | Subject was admitted to the hospital for increased abdominal pain due to an IBD flare, the adverse event was resolved. The IBD flare occurred prior to administration of study drug, the subject continued in the study with no further issues. |
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| Hospitalization | Gastrointestinal disorders | Non-systematic Assessment | Subject was hospitalized for worsening of ongoing baseline symptoms of rectal bleeding, diarrhea, and abdominal pain. The patient was treated for these symptoms and this adverse event was resolved. |
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| IBD flare | Gastrointestinal disorders | Non-systematic Assessment | Subject experienced an IBD flare for which they were hospitalized. Patient was started on biologic treatment and deemed clinically stable for discharge. |
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| IBD flare | Gastrointestinal disorders | Non-systematic Assessment | Subject experienced flare symptoms, which was treated by switching their IBD medications. The patient's symptoms improved with the treatment. |
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| Colectomy | Gastrointestinal disorders | Non-systematic Assessment | Subject was admitted to the hospital for pain and nausea. They underwent total abdominal colectomy and end ileostomy and were discharged with antibiotics. |
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| Hospitalization | Gastrointestinal disorders | Non-systematic Assessment | Subject was admitted for abdominal pain, diarrhea, and vomiting. They received IV steroids and antibiotics prior to discharged which resolved symptoms. |
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| Rectal Bleeding | Gastrointestinal disorders | Non-systematic Assessment |
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| Abdominal Pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
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| Chest Rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Fatigue | General disorders | Non-systematic Assessment |
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| Headache | General disorders | Non-systematic Assessment |
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| Fever | General disorders | Non-systematic Assessment |
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| Fecal urgency | Gastrointestinal disorders | Non-systematic Assessment |
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| Flatulence | Gastrointestinal disorders | Non-systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | Non-systematic Assessment |
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| Dermatitis Radiation | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Urinary incontinence | Renal and urinary disorders | Non-systematic Assessment |
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| Herpes Simplex Reactivation | Infections and infestations | Non-systematic Assessment |
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| Flushing | Vascular disorders | Non-systematic Assessment |
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| Bloating | Gastrointestinal disorders | Non-systematic Assessment |
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| Allergic reaction | Immune system disorders | Non-systematic Assessment |
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| Thrombocytopenia | Vascular disorders | Non-systematic Assessment |
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| COVID-19 Infection | General disorders | Non-systematic Assessment |
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| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
| D017670 |
| Sodium Compounds |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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