The Use of Oral Budesonide and Rectal Hydrocortisone for the Treatment of Active Ulcerative Colitis
Condition: Inflammatory Bowel Disease; Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer
Intervention: Combination Oral Budesonide and Rectal Hydrocortisone
Intervention description: Budesonide 9 mg PO (oral) daily and hydrocortisone 100 mL PR (enema) for an 8-week period. The doses of each drug to be used in the pilot study are standard doses used in clinical practice. After 8-weeks, the budesonide will be tapered in the following manner: 1) budesonide 6 mg PO daily and hydrocortisone 100 ml PR every other day (EOD) for 3 weeks then 2) budesonide 3 mg PO daily and hydrocortisone 100 ml PR 2 x per week for 3 weeks then 3) discontinue budesonide.
Intervention MeSH terms: Budesonide; Hydrocortisone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Inflammatory Bowel Disease; Ulcerative Colitis; Budesonide; Corticosteroids

Summary:

      The purpose of this study is to evaluate if the combination of oral budesonide and rectal
      hydrocortisone improves symptoms in patients with active ulcerative colitis. Also, we would
      like to determine if oral budesonide and rectal hydrocortisone has fewer and less severe side
      effects compared to standard steroids (prednisone).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written, voluntary, informed consent given

          -  18 years or older

          -  Speak and read English

          -  Extensive ulcerative colitis based upon endoscopy, histopathology, and clinical
             symptoms

          -  SCCAI Score > 3

          -  Presence of diarrhea (3 or more bowel movements per 24 hours) AND grossly visible
             blood in stool

        Exclusion Criteria:

          -  Serum creatinine > 2.0 mg/dL

          -  Pregnant or breastfeeding

          -  Prior history of total or subtotal colectomy, or currently has an ostomy

          -  History or suspicion of Crohn's disease or Indeterminate colitis

          -  Diagnosis of any condition deemed by the investigator inhibiting completion of the
             trial

          -  Initiated therapy with or change in mesalamine dose within the last 4 weeks

          -  Change in azathioprine, 6-mercaptopurine, or cyclosporine within the last 8 weeks

          -  Currently taking or have used corticosteroids within the last 8 weeks

          -  Rectally administered mesalamine or steroids within the last 2 weeks

          -  Current or prior use of anti-TNF alpha agents within the last 8 weeks

          -  Experimental ulcerative colitis agents within the last 8 weeks

          -  Concomitant use of CYP3A4 activity inhibitor (e.g. ketoconazole, itraconazole,
             ritonavir, indinavir, erythromycin)

          -  Uncontrolled diabetes (HgA1c > 8.0) within 1 year

          -  Unstable Coronary artery disease/Class III/IV CHF

          -  Decompensated cirrhosis (e.g. encephalopathy, renal failure, ascites, GIB)

          -  Any known infection requiring antibiotics

          -  Active Clostridium difficile infection

          -  COPD requiring home oxygen

          -  HIV/AIDS with CD4 < 200 or AIDs-defining illnesses/infections