Localized Therapeutics for the Treatment of Gastrointestinal Disorders II

Inclusion Criteria:

- Voluntarily sign written informed consent.

- Male or non-pregnant and non-lactating females at least 8 years of age.

- Confirmed diagnosis of active, mild to moderate ulcerative proctitis or
proctosigmoiditis extending no further than 40cm from the anal verge. Typically,
baseline Mayo Disease Activity Index (MMDAI) score between 5 and 10 (indicating mild
to moderate disease).

Exclusion Criteria:

- Known infection with Clostridium difficile (C. difficile) and/or other enteric
pathogens

- 5-aminosalicylic acid (5-ASA) intolerance

- Current or recent (3 weeks) oral or rectal steroids

- History of thiopurine or Anti-tumor necrosis factor (Anti-TNF) alpha treatment for
colitis

- Abnormal creatinine

- Previous small bowel or colonic resection,

- Anal sphincter incompetence,

- Current smokers.

- History or current diagnosis of Crohn's disease or indeterminate colitis.

- History of diverticulitis, collagenous colitis, celiac disease, recurrent pancreatic
or known gallbladder disease.

- Unstable significant cardiovascular, endocrine, neurologic or pulmonary disease.

- Hemoglobin levels < 7.5 g/dL.

- History of sclerosing cholangitis, cirrhosis, or hepatic impairment

- Pregnant or at risk of pregnancy.

- Some medications to treat UC are prohibited during participation in the study,
including laxatives and anti-diarrhea medications; oral 5-ASA agents and daily fiber
supplements are allowed.