Children who are between the ages of 4 and 17 years who have no evidence of intestinal infection and who are undergoing evaluation for possible UC are candidates for PROTECT. Exposure to certain other medications or co-existing medical conditions may eliminate some children from consideration.
  • Currently at least 4 years old up to their 18th birthday
  • Weigh at least 15kg. or 33lbs.
  • New diagnosis of ulcerative colitis
  • No therapy previously initiated to treat the newly diagnosed ulcerative colitis
  • Stool culture negative for infection
  • Ability to remain in follow-up for a minimum of one year from diagnosis
  • Crohn’s disease
  • Use of any oral steroid medication for non-gastrointestinal indication within the past 4 weeks (e.g., asthma)
  • History of use of immunosuppressive medications for other medical conditions (e.g., juvenile rheumatoid arthritis)
  • Pregnancy
  • Subjects with poorly controlled medical conditions (e.g. diabetes, congestive heart failure, kidney insufficiency, chronic liver disease)