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| Name | Class |
|---|---|
| Children's Hospital of Philadelphia | OTHER |
| Crohn's and Colitis Foundation | OTHER |
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To determine the effect of a novel gut microbiota-targeted therapeutic regimen (bowel lavage and antibiotics with or without an antifungal) in the management of active Crohn's Disease (CD) that is refractory to conventional, immunosuppressive therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluconazole | Experimental | Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus fluconazole 400 mg orally once daily (Day 1-14). PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). |
|
| Placebo | Placebo Comparator | Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus placebo for fluconazole. PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluconazole | Drug | 400mg orally once daily (Day 1-14) |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Disease Activity by Harvey Bradshaw Index | The primary endpoint will be the change in disease activity, as measured by Harvey-Bradshaw Index (HBI) score, between the enrollment visit and Day 15. All participants who withdraw for any reason prior to day 15 will be considered treatment failures. The HBI is a clinical score where points are given for each category below plus number of liquid bowel movements in previous day. A score of 3 or lower is considered remission. A score of 8 or higher is considered severe disease. General Well Being Very well 0 points Slightly below par 1 point Poor 2 points Very poor 3 points Terrible 4 points Abdominal Pain None 0 points Mild 1 point Moderate 2 points Severe 3 points Abdominal Mass None 0 points Dubious 1 point Definite 2 points Definite and tender 3 points Complications None 0 points Arthralgias +1 point Uveitis +1 point Erythema Nodosum + 1 point Aphthous ulcers +1 point Pyoderma Gangrenosum + 1 point Anal fissure + 1 point New fistula + 1 | enrollment visit (baseline) and 15 days |
| Change in Disease Activity by Fecal Calprotectin (FCP) | The second primary outcome measure will be the change in disease activity, as measured by fecal calprotectin, between the enrollment visit and day 15. The fecal calprotectin is a stool test which measures intestinal inflammation. | enrollment visit (baseline) and 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| The Change in High-sensitivity C-reactive Protein (hsCRP) | A secondary outcome measure will be the change in high-sensitivity C-reactive protein between the enrollment visit and day 15. The high-sensitivity C-reactive protein is a blood test which measures systemic inflammation. | enrollment visit (baseline) and 15 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lindsey Albenberg, DO | University of Pennsylvania | Principal Investigator |
| James D Lewis, MD, MSCE | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fluconazole | Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus fluconazole 400 mg orally once daily (Day 1-14). PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). Fluconazole: 400mg orally once daily (Day 1-14) Vancomycin: 500mg oral suspension 4 times daily (Day 1-14) Neomycin: neomycin 1000 mg orally three times daily (Days 1-3) Ciprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14) Polyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2 Promethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). |
| FG001 | Placebo | Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus placebo for fluconazole. PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). Vancomycin: 500mg oral suspension 4 times daily (Day 1-14) Neomycin: neomycin 1000 mg orally three times daily (Days 1-3) Ciprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14) Polyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2 Promethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). Fluconazole placebo: Once daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fluconazole | Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus fluconazole 400 mg orally once daily (Day 1-14). PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). Fluconazole: 400mg orally once daily (Day 1-14) Vancomycin: 500mg oral suspension 4 times daily (Day 1-14) Neomycin: neomycin 1000 mg orally three times daily (Days 1-3) Ciprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14) Polyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2 Promethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Change in Disease Activity by Harvey Bradshaw Index | The primary endpoint will be the change in disease activity, as measured by Harvey-Bradshaw Index (HBI) score, between the enrollment visit and Day 15. All participants who withdraw for any reason prior to day 15 will be considered treatment failures. The HBI is a clinical score where points are given for each category below plus number of liquid bowel movements in previous day. A score of 3 or lower is considered remission. A score of 8 or higher is considered severe disease. General Well Being Very well 0 points Slightly below par 1 point Poor 2 points Very poor 3 points Terrible 4 points Abdominal Pain None 0 points Mild 1 point Moderate 2 points Severe 3 points Abdominal Mass None 0 points Dubious 1 point Definite 2 points Definite and tender 3 points Complications None 0 points Arthralgias +1 point Uveitis +1 point Erythema Nodosum + 1 point Aphthous ulcers +1 point Pyoderma Gangrenosum + 1 point Anal fissure + 1 point New fistula + 1 | Posted | Median | Full Range | score on a scale | enrollment visit (baseline) and 15 days |
|
105 days
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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 | Fluconazole | Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus fluconazole 400 mg orally once daily (Day 1-14). PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). Fluconazole: 400mg orally once daily (Day 1-14) Vancomycin: 500mg oral suspension 4 times daily (Day 1-14) Neomycin: neomycin 1000 mg orally three times daily (Days 1-3) Ciprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14) Polyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2 Promethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
Recruitment was difficult due to intensive methods with large number of/frequent study visits required. Small sample size is a major limitation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lindsey Albenberg, DO | University of Pennsylvania | 267-426-0139 | albenbergl@email.chop.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 | Aug 11, 2017 | Aug 20, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D015725 | Fluconazole |
| D014640 | Vancomycin |
| D009355 | Neomycin |
| D002939 | Ciprofloxacin |
| C000595212 | polyethylene glycol 3350 |
| D011398 | Promethazine |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Vancomycin | Drug | 500mg oral suspension 4 times daily (Day 1-14) |
|
|
| Neomycin | Drug | neomycin 1000 mg orally three times daily (Days 1-3) |
|
|
| Ciprofloxacin | Drug | ciprofloxacin 750 mg orally twice daily (Day 4-14) |
|
|
| Polyethylene Glycol 3350 | Drug | 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2 |
|
|
| Promethazine | Drug | PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). |
|
|
| Fluconazole placebo | Drug | Once daily |
|
| Safety and Tolerability of the Treatment Regimen Based on Medication Side Effects and/or Adverse Events (AEs). |
Number of Medication Side Effects and/or Adverse Events (AEs) |
| 105 days |
| BG001 | Placebo | Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus placebo for fluconazole. PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). Vancomycin: 500mg oral suspension 4 times daily (Day 1-14) Neomycin: neomycin 1000 mg orally three times daily (Days 1-3) Ciprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14) Polyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2 Promethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). Fluconazole placebo: Once daily |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Fluconazole |
Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus fluconazole 400 mg orally once daily (Day 1-14). PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). Fluconazole: 400mg orally once daily (Day 1-14) Vancomycin: 500mg oral suspension 4 times daily (Day 1-14) Neomycin: neomycin 1000 mg orally three times daily (Days 1-3) Ciprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14) Polyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2 Promethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). |
| OG001 | Placebo | Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus placebo for fluconazole. PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). Vancomycin: 500mg oral suspension 4 times daily (Day 1-14) Neomycin: neomycin 1000 mg orally three times daily (Days 1-3) Ciprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14) Polyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2 Promethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). Fluconazole placebo: Once daily |
|
|
| Primary | Change in Disease Activity by Fecal Calprotectin (FCP) | The second primary outcome measure will be the change in disease activity, as measured by fecal calprotectin, between the enrollment visit and day 15. The fecal calprotectin is a stool test which measures intestinal inflammation. | Posted | Median | Full Range | mcg/g | enrollment visit (baseline) and 15 days |
|
|
|
| Secondary | The Change in High-sensitivity C-reactive Protein (hsCRP) | A secondary outcome measure will be the change in high-sensitivity C-reactive protein between the enrollment visit and day 15. The high-sensitivity C-reactive protein is a blood test which measures systemic inflammation. | Posted | Median | Full Range | mg/dL | enrollment visit (baseline) and 15 days |
|
|
|
| Secondary | Safety and Tolerability of the Treatment Regimen Based on Medication Side Effects and/or Adverse Events (AEs). | Number of Medication Side Effects and/or Adverse Events (AEs) | Posted | Number | Events | 105 days |
|
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 4 |
| 4 |
| EG001 | Placebo | Vancomycin 500 mg oral suspension four times daily (Day 1-14), plus neomycin 1000 mg orally three times daily (Days 1-3), plus ciprofloxacin 750 mg orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2, plus placebo for fluconazole. PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). Vancomycin: 500mg oral suspension 4 times daily (Day 1-14) Neomycin: neomycin 1000 mg orally three times daily (Days 1-3) Ciprofloxacin: ciprofloxacin 750 mg orally twice daily (Day 4-14) Polyethylene Glycol 3350: 238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2 Promethazine: PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3). Fluconazole placebo: Once daily | 0 | 4 | 0 | 4 | 3 | 4 |
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Increased abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Increased diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Perianal irritation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Flushing | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Decreased appetite | Gastrointestinal disorders | Non-systematic Assessment |
|
| Eye irritation | Eye disorders | Non-systematic Assessment |
|
| Defecation urgency | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D007410 | Intestinal Diseases |
| D006020 |
| Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D010640 | Phenothiazines |
| D013457 | Sulfur Compounds |
| D006575 | Heterocyclic Compounds, 3-Ring |