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

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