Therapeutic Modulation of the Intestinal Creatine Kinase System in Inflammatory Bowel Disease (IBD)

Inclusion Criteria:

• Male or female patients aged 18-70 years old with mild- to moderately-active UC thatextends at least 15 cm proximal to the anal verge (i.e. not proctitis) as defined by aMayo Score of 3-10, with an endoscopic subscore ≥ 1.
• Allowed concomitant medications will include mesalamine compounds if used for at least 8 weeks and at a stable dose for at least 4 weeks, as well as thiopurines (azathioprine, 6-mercaptopurine) if used at a stable dose for at least 3 months.

Exclusion Criteria:

• Abnormal baseline laboratory tests:
• Albumin < 3.0 g/dL
• ALT, AST, total bilirubin, or alkaline phosphatase > 1.5 x ULN
• Potassium < 3.0 mmol/L or > 5.5 mmol/L
• Creatinine or cystatin C > ULN
• WBC ≤ 3000
• Platelets ≤ 105
• Hemoglobin ≤ 10g/dL
• Positive stool test for Clostridium difficile, ova and parasites, or routinestool culture
• Pregnancy (as confirmed by urine pregnancy test at study outset), stated desire tobecome pregnant during the study period, or refusal/inability to use effective methodsof contraception during the study period.
• Concomitant major comorbidities (renal, hepatic, cardiac, pulmonary or malignancy) toinclude any medical conditions requiring therapeutic anti-coagulation or anti-platelettherapy.
• Diagnosis of severe UC (Mayo Score > 10)
• Evidence or history of toxic megacolon
• Patients who received anti-TNF agents within 3 months of screening, or who used oralor rectal corticosteroids within 4 weeks of screening will be excluded.
• Use of over-the-counter herbal or dietary supplements (excluding vitamin and minerals)two weeks prior to or during the study period.
• Use of known nephrotoxic medications (including non-steroidal anti-inflammatory drugs (NSAIDs), cyclosporin A, tacrolimus, aminoglycoside antibiotics, diuretics,angiotensin converting enzyme (ACE) inhibitors, or angiotensin receptor blockers) 2weeks prior to or during the study period
• Prior surgical bowel resections (excluding appendectomy)
• Local or systemic complications or other pathological states requiring therapy withcorticosteroids and/or immunosuppressive agents.