Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Colorado, Denver
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female patients aged 18-70 years old with mild- to moderately-active UC that extends at least 15 cm proximal to the anal verge (i.e. not proctitis) as defined by a Mayo 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.
You may not be if
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 routine stool culture
Pregnancy (as confirmed by urine pregnancy test at study outset), stated desire to become pregnant during the study period, or refusal/inability to use effective methods of contraception during the study period.
Concomitant major comorbidities (renal, hepatic, cardiac, pulmonary or malignancy) to include any medical conditions requiring therapeutic anti-coagulation or anti-platelet therapy.
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 oral or 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) 2 weeks prior to or during the study period
