Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease (Holiday)
Crohn's Disease
About this trial
This is an interventional treatment trial for Crohn's Disease
Eligibility Criteria
Inclusion Criteria:
- Participant is capable of giving informed consent
- Males or females 18-75 years of age
- Normal kidney function (defined by normal serum creatinine [male: <1.27 mg/dL; female: <1.03 mg/dL])
- Normal aspartate aminotransferase [AST] (<41 U/L), alanine aminotransferase [ALT] (<63 U/L), and alkaline phosphatase (<126 U/L)
- Active CD defined as HBI ≥ 7
- CRP > 5 mg/dL or hs-CRP > 10mg/L (or 1mg/dL) or fecal calprotectin (FCP) > - - 350 mcg/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.
Exclusion Criteria:
- Known or suspected stricturing disease producing obstructive symptoms
- Active Clostridium difficile infection
- Unwillingness to provide informed consent
- Allergy or intolerance to the medications used in this study
- History of kidney disease
- History of liver disease
- Pregnant or lactating females
- Baseline QTc interval on EKG > 430 in males or > 450 in females
- Participants who, in the opinion of the investigator, may be non-compliant with study schedules or procedures
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Fluconazole
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 fluconazole 400 mg orally once daily (Day 1-14). PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).
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).