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

• Status: Completed
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Collaborators: Children's Hospital of Philadelphia; Crohn's and Colitis Foundation
• Treatments: Ciprofloxacin; Diphenhydramine; Fluconazole; Neomycin; Polyethylene glycol 3350; Promethazine; Vancomycin

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