Study of the Safety and Tolerability of ALTH12 Versus Mesalamine Enema in Subjects With Left-Sided Ulcerative Colitis

Exclusion Criteria

• •Subjects will be excluded if:
• •They have documented history of proctitis or active proctitis confined to 15cm or less from the anal verge.
• •They demonstrate signs and symptoms of fulminant colitis, bowel stricture, toxic megacolon, an anticipated need for blood transfusion for gastrointestinal bleeding, or demonstrate evidence of peritonitis.
• •They receive a Physician's rating of disease severity as part of the modified UCDAI of 2 or greater (moderate or severe disease) or an endoscopy score of 2 or greater.
• •They have shown evidence of high grade dysplasia on endoscopic examinations.
• •Their stool contains enteric pathogens or Clostridium difficile toxins.
• •They have a history of recurrent Clostridium difficile infection.
• •They have prior history of biologic therapy.
• •They have received systemic steroids or immunosuppressants within the previous 4 weeks.
• •Treatment in the last 2 weeks that included antibiotic, antifungal, antiparasitic medications, or rectally administered steroids (e.g. Cortenema®) and/or 5-ASA enema (e.g. Rowasa®).
• •They have a history of cancer (defined as malignancy within 5 years except for squamous cell or basal cell cancers of the skin), asthma, or bronchospasm.
• •Positive pregnancy test or lactating subjects.
• •There is evidence of chemical abuse.
• •They have a known allergy to N-acetylcysteine or Mesalamine.
• •They have a history of failure to retain enemas.
• •Other clinically significant diseases that could interfere with the protocol compliance appear. These would include clinically important hematological, renal, hepatic, metabolic, psychiatric, central nervous system (CNS), pulmonary or cardiovascular disease.
• •Any condition which the study physician judges to preclude safe participation in the study or to confound the evaluation of the study outcome.