Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease

Fundamental Modification of the Gut Microbiota in the Treatment of Refractory Crohn's Disease

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.

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