Pilot Study of Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease
NCT ID: NCT03476317
Last Updated: 2022-02-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
10 participants
INTERVENTIONAL
2018-07-12
2020-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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)
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
Group 2
Collect stool samples for calprotectin in patients undergoing colonoscopy for clinical care to evaluate effect of bowel lavage alone on calprotectin.
No interventions assigned to this group
Interventions
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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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Current weight \>10 kg (or 22 lb)
* Ability to swallow pills
* Normal kidney function
* Normal Aspartate transaminase (AST), Alanine transaminase (ALT), and alkaline phosphatase
* Active CD or IBDU defined as PCDAI ≥ 30
* C-Reactive Protein (CRP) ≥ 15mg/L (or 1.5mg/dL) or fecal calprotectin (FCP)\>350mcg/g (within one month of enrollment)
* Have been treated with one of the following therapies for at least 8 weeks with primary nonresponse or an initial response, followed by loss of response \[LOR\] (self-reported worsening of symptoms for ≥ 7 days): azathioprine, 6-mercaptopurine, methotrexate, adalimumab, certolizumab, golimumab, infliximab, natalizumab, vedolizumab, or ustekinumab \*\*These medications must have been administered at standard, therapeutic dosages.
* Males or females 10 years of age and older.
* Patients undergoing a clinical GI endoscopy due to suspicion for active intestinal inflammation determined by physician global assessment (PGA).
* Undergoing a bowel preparation as part of clinical care.
* Parental/guardian permission (informed consent) and if appropriate, child assent.
Exclusion Criteria
* Current use of one or more of the following medications: 5-fluorouracil, digoxin, anticoagulants, theophylline, phenytoin, probenecid, duloxetine, clozapine, sildenafil, hydrochlorothiazide, cyclosporine, hypoglycemics, terfenadine, tacrolimus, rifabutin, midazolam, and voriconazole
* Known diagnosis of diabetes mellitus
* Known or suspected structuring disease producing obstructive symptoms
* Active Clostridium difficile infection
* Prolonged QTc interval as seen on enrollment EKG
* Current use of antibiotics
* Starting or increasing the dose of an IBD related medication within 4 weeks of screening
Group 2
* Antibiotic use within the past 30 days.
* Current presence of an ostomy bag.
* Patients undergoing a non- polyethylene glycol 3350 cleanout.
* Unwillingness to provide informed consent.
* Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
6 Years
ALL
No
Sponsors
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University of Pennsylvania
OTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Children's Hospital of Philadelphia
OTHER
Responsible Party
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Principal Investigators
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Lindsey Albenberg, DO
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Locations
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Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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17-014343
Identifier Type: -
Identifier Source: org_study_id
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