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

Clinical Trial ID: NCT03476317


The purpose of this study is 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.

Investigators will evaluate the efficacy of a novel treatment regimen, employing non-immunosuppressive medications, in the management of refractory CD. Refractory patients include those patients who have experienced loss of responsiveness (LOR) or primary nonresponse to an immunomodulator or a biologic. Investigators will treat participants with a combination of gut microbiota-targeted therapies to restore a healthy gut microbiome composition. Investigators believe that this strategy will both treat the gut inflammation associated with inflammatory bowel disease (IBD) as well as salvage response to immune suppressive therapies.


Inclusion Criteria: - Males or females 6-18 years of age - 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 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. Exclusion Criteria: - Known allergy or intolerance to aminoglycosides or any of the medications used in this study - 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

  • Start Date


  • Last Updated


  • Sponsor

    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  • Condition Name

    Crohn Disease

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