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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23DK109136-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Pennsylvania | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The purpose of this study is 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) or indeterminate colitis (IBDU) that is refractory to conventional, immunosuppressive therapy. In addition, the study will determine the effect of PEG lavage alone on fecal calprotectin and gut microbiota in patients who are undergoing a PEG lavage for clinical care.
Investigators will evaluate the efficacy of a novel treatment regimen, employing non-immunosuppressive medications, in the management of refractory CD or IBDU. Refractory patients include those patients who have experienced loss of responsiveness (LOR) or primary nonresponse to an immunomodulator or a biologic. Investigators will treat participants with a combination of gut microbiota-targeted therapies to restore a healthy gut microbiome composition. Investigators believe that this strategy will both treat the gut inflammation associated with inflammatory bowel disease (IBD) as well as salvage response to immune suppressive therapies.
Investigators will also evaluate the effect of PEG lavage alone on fecal calprotectin and gut microbiota. Participants in this arm, will be undergoing a PEG lavage in preparation for a endoscopy for clinical care. They will be asked to provide stool samples, prior to and after their PEG lavage. Participants will not be receiving any investigational treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1-Fluconazole | Experimental | Vancomycin oral suspension four times daily (Day 1-14), plus neomycin orally three times daily (Days 1-3), plus ciprofloxacin orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) dissolved in Gatorade on day 2, plus fluconazole orally once daily (Day 1-14). |
|
| Group 1-Placebo | Placebo Comparator | Vancomycin oral suspension four times daily (Day 1-14), plus neomycin orally three times daily (Days 1-3), plus ciprofloxacin orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) dissolved in Gatorade on day 2, plus placebo. |
|
| Group 2 | No Intervention | Collect stool samples for calprotectin in patients undergoing colonoscopy for clinical care to evaluate effect of bowel lavage alone on calprotectin. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vancomycin | Drug | Oral suspension 4 times daily (Day 1-14) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in FCP in Group 2 Participants | Change in fecal calprotectin between stool samples collected at baseline and day 12 after procedure in Group 2 participants. | change from baseline to day 12 |
| Change in Disease Activity by Pediatric Crohn's Disease Activity Index | The primary endpoint will be the change in disease activity, as measured by Pediatric Crohn's Disease Activity Index (PCDAI) 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 Pediatric Crohn's Disease Activity Index is a clinical score which takes into account general well being, degree of abdominal pain, number of liquid stools per day, abdominal physical examination, and Crohn's disease complications. | Baseline, Day 15 |
| 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. | Baseline, Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in C-reactive Protein (CRP) | A secondary outcome measure will be the change in C-reactive protein between the enrollment visit and day 15. The C-reactive protein is a blood test which measures systemic inflammation. | Baseline, Day 15 |
| Safety and Tolerability of the Treatment Regimen Based on Medication Side Effects and/or Adverse Events |
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Group 1
Inclusion Criteria:
Exclusion Criteria:
Group 2
Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Lindsey Albenberg, DO | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19146 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1-Fluconazole | Vancomycin oral suspension four times daily (Day 1-14), plus neomycin orally three times daily (Days 1-3), plus ciprofloxacin orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) dissolved in Gatorade on day 2, plus fluconazole orally once daily (Day 1-14). Vancomycin: Oral suspension 4 times daily (Day 1-14) Neomycin: Oral three times daily (Days 1-3) Ciprofloxacin: Oral twice daily (Days 4-14) Polyethylene Glycol 3350: Dissolved in Gatorade on day 2 Fluconazole: Orally once daily (Day 1-14) |
| FG001 | Group 1-Placebo | Vancomycin oral suspension four times daily (Day 1-14), plus neomycin orally three times daily (Days 1-3), plus ciprofloxacin orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) dissolved in Gatorade on day 2, plus placebo. Vancomycin: Oral suspension 4 times daily (Day 1-14) Neomycin: Oral three times daily (Days 1-3) Ciprofloxacin: Oral twice daily (Days 4-14) Polyethylene Glycol 3350: Dissolved in Gatorade on day 2 |
| FG002 | Group 2 | Collect stool samples for calprotectin in patients undergoing colonoscopy for clinical care to evaluate effect of bowel lavage alone on calprotectin. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
An identical study was simultaneously enrolling adult patients and results from the adult study were sufficient to make a conclusion without enrolling children. (NCT02765256)
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1-Fluconazole | Vancomycin oral suspension four times daily (Day 1-14), plus neomycin orally three times daily (Days 1-3), plus ciprofloxacin orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) dissolved in Gatorade on day 2, plus fluconazole orally once daily (Day 1-14). Vancomycin: Oral suspension 4 times daily (Day 1-14) Neomycin: Oral three times daily (Days 1-3) Ciprofloxacin: Oral twice daily (Days 4-14) Polyethylene Glycol 3350: Dissolved in Gatorade on day 2 Fluconazole: Orally once daily (Day 1-14) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 FCP in Group 2 Participants | Change in fecal calprotectin between stool samples collected at baseline and day 12 after procedure in Group 2 participants. | Group 1 study was not done. | Posted | Median | Full Range | mcg/g | change from baseline to day 12 |
|
14 days
Group 1 study was not completed
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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 | Group 1-Fluconazole | Vancomycin oral suspension four times daily (Day 1-14), plus neomycin orally three times daily (Days 1-3), plus ciprofloxacin orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) dissolved in Gatorade on day 2, plus fluconazole orally once daily (Day 1-14). Vancomycin: Oral suspension 4 times daily (Day 1-14) Neomycin: Oral three times daily (Days 1-3) Ciprofloxacin: Oral twice daily (Days 4-14) Polyethylene Glycol 3350: Dissolved in Gatorade on day 2 Fluconazole: Orally once daily (Day 1-14) |
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Group 1 study was not completed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lindsey Albenberg, DO | Children's Hospital of Philadelphia | 267-426-0139 | albenbergl@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 | Dec 20, 2019 | Nov 23, 2021 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 19, 2020 | Mar 22, 2021 | ICF_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 |
|---|---|
| D014640 | Vancomycin |
| D009355 | Neomycin |
| D002939 | Ciprofloxacin |
| C000595212 | polyethylene glycol 3350 |
| D015725 | Fluconazole |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
Not provided
Not provided
Not provided
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| Neomycin | Drug | Oral three times daily (Days 1-3) |
|
|
| Ciprofloxacin | Drug | Oral twice daily (Days 4-14) |
|
|
| Polyethylene Glycol 3350 | Drug | Dissolved in Gatorade on day 2 |
|
|
| Fluconazole | Drug | Orally once daily (Day 1-14) |
|
|
| 105 days |
| BG001 | Group 1-Placebo | Vancomycin oral suspension four times daily (Day 1-14), plus neomycin orally three times daily (Days 1-3), plus ciprofloxacin orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) dissolved in Gatorade on day 2, plus placebo. Vancomycin: Oral suspension 4 times daily (Day 1-14) Neomycin: Oral three times daily (Days 1-3) Ciprofloxacin: Oral twice daily (Days 4-14) Polyethylene Glycol 3350: Dissolved in Gatorade on day 2 |
| BG002 | Group 2 | Collect stool samples for calprotectin in patients undergoing colonoscopy for clinical care to evaluate effect of bowel lavage alone on calprotectin. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | 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 |
|
| Calprotectin | Median | Full Range | mcg/g |
|
| OG001 |
| Group 1-Placebo |
Vancomycin oral suspension four times daily (Day 1-14), plus neomycin orally three times daily (Days 1-3), plus ciprofloxacin orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) dissolved in Gatorade on day 2, plus placebo. Vancomycin: Oral suspension 4 times daily (Day 1-14) Neomycin: Oral three times daily (Days 1-3) Ciprofloxacin: Oral twice daily (Days 4-14) Polyethylene Glycol 3350: Dissolved in Gatorade on day 2 |
| OG002 | Group 2 | Collect stool samples for calprotectin in patients undergoing colonoscopy for clinical care to evaluate effect of bowel lavage alone on calprotectin. |
|
|
|
| Primary | Change in Disease Activity by Pediatric Crohn's Disease Activity Index | The primary endpoint will be the change in disease activity, as measured by Pediatric Crohn's Disease Activity Index (PCDAI) 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 Pediatric Crohn's Disease Activity Index is a clinical score which takes into account general well being, degree of abdominal pain, number of liquid stools per day, abdominal physical examination, and Crohn's disease complications. | This outcome was specific to Group 1 and we did not enroll patients into Group1as an identical study was simultaneously enrolling adult patients and results from the adult study were sufficient to make a conclusion without enrolling children. | Posted | Baseline, Day 15 |
|
|
| 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. | This outcome was specific to Group 1 and Group 1 study was not completed. | Posted | Baseline, Day 15 |
|
|
| Secondary | Change in C-reactive Protein (CRP) | A secondary outcome measure will be the change in C-reactive protein between the enrollment visit and day 15. The C-reactive protein is a blood test which measures systemic inflammation. | This outcome was specific to Group 1 and Group 1 study was not completed. | Posted | Baseline, Day 15 |
|
|
| Secondary | Safety and Tolerability of the Treatment Regimen Based on Medication Side Effects and/or Adverse Events | This outcome is specific to Group 1 and Group 1 study was not completed. | Posted | 105 days |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Group 1-Placebo | Vancomycin oral suspension four times daily (Day 1-14), plus neomycin orally three times daily (Days 1-3), plus ciprofloxacin orally twice daily (Day 4-14), plus Polyethylene Glycol 3350 (Miralax) dissolved in Gatorade on day 2, plus placebo. Vancomycin: Oral suspension 4 times daily (Day 1-14) Neomycin: Oral three times daily (Days 1-3) Ciprofloxacin: Oral twice daily (Days 4-14) Polyethylene Glycol 3350: Dissolved in Gatorade on day 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Group 2 | Collect stool samples for calprotectin in patients undergoing colonoscopy for clinical care to evaluate effect of bowel lavage alone on calprotectin. | 0 | 10 | 0 | 10 | 0 | 10 |
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Not provided
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| D007410 | Intestinal Diseases |
| 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 |
| D006571 | Heterocyclic Compounds |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| >=65 years |
|