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| Name | Class |
|---|---|
| Indiana University | OTHER |
| Icahn School of Medicine at Mount Sinai | OTHER |
| The Miriam Hospital | OTHER |
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In this study the investigators will evaluate patients with IBD and and at least 2 confirmed c.difficile infections who will be undergoing FMT. The investigators will assess patients before FMT and then follow patients prospectively post FMT at week 1, 8 and 12 to assess for recurrence of c.difficile infection and IBD outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | All patients in this study will receive Fecal Microbiota Tranplantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal Microbiota Transplantation | Drug | Patients with at least 2 episodes of CDI and IBD will undergo a single FMT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With FMT Failure | Recurrence of c.diffile infection | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Participants Colonized With C.Difficile | asymptomatic patients with positive stool testing for c.difficile via polymerase chain reaction testing | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica R Allegretti, MD, MPH | Brigham and Women's Hospital | Principal Investigator |
| 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 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 FMT Failure | Recurrence of c.diffile infection | Posted | Count of Participants | Participants | 8 weeks |
|
|
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 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment | Subject required blood transfusion due to severe anemia. This AE was determined unrelated to treatment and due to previous condition. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
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| 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 | Jul 7, 2019 | Apr 9, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003015 | Clostridium Infections |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Baseline Calprotectin | Mean | Standard Deviation | mg/L |
|
| Baseline C-Reactive Protein | Mean | Standard Deviation | ug/g |
|
| Average Bowel Movements | Mean | Standard Deviation | bowel movements |
|
| Average Bristol Score | Range 1-7. Low scores represent hard stools and high numbers represent liquid stools | Mean | Standard Deviation | units on a scale |
|
| Average Complete Mayo | Range 0-12. The score is a ulcerative colitis disease activity assessement and has 4 components: bowel movements, rectal bleeding, physical global assessment and endoscopy score. 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. | Mean | Standard Deviation | units on a scale |
|
| Average 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. | Mean | Standard Deviation | units on a scale |
|
| Average 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. | Mean | Standard Deviation | units on a scale |
|
|
| Secondary | Participants Colonized With C.Difficile | asymptomatic patients with positive stool testing for c.difficile via polymerase chain reaction testing | Posted | Count of Participants | Participants | 8 weeks |
|
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| 0 |
| 50 |
| 3 |
| 50 |
| 49 |
| 50 |
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| IBD Flare | Gastrointestinal disorders | Non-systematic Assessment | The subject had IBD flare that required hospitalization. This was deemed to be unrelated to study treatment and reported at the week 8 follow-up. |
|
| IBD Flare | Gastrointestinal disorders | Non-systematic Assessment | Patient was experiencing Diarrhea and a fever due to an IBD flare. Subject was admitted to hospital and treated with an IV of omnipaque and later discharged. |
|
| 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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| Fever | General disorders | Non-systematic Assessment |
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| Fatigue | General disorders | Non-systematic Assessment |
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| Heart Burn | Gastrointestinal disorders | Non-systematic Assessment |
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| Chills | General disorders | Non-systematic Assessment |
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| Migraine | Nervous system disorders | Non-systematic Assessment |
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| Yeast Infection | Renal and urinary disorders | Non-systematic Assessment |
|
| Constiption | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |