Gastroenterology Research

Principal Investigators:
  • Ashish Patel, MD
For more information, contact:
  • Takiyah R. Wilson, BS, MBA (214) 456-9238
  • Deborah McElroy, RN, BSN (214) 456-8792

Predicting Response to Standardized Pediatric Colitis Therapy: The PROTECT Study

  • This multicenter open-label study is designed to evaluate the safety and efficacy of standardized initial therapy using either mesalamine or corticosteroids then mesalamine for the treatment of children and adolescents newly diagnosed with ulcerative colitis. The study will investigate the hypothesis that response to the initial 4 weeks of therapy as well as specific clinical, genetic, and immune parameters determined during the initial course of therapy will predict severe disease as reflected by need for escalation of medical therapy or surgery
  • Inclusion Critera:
    • Age ≥ 4years and ≤17 years at initiation of therapy
    • Weight ≥15 kg
    • New diagnosis of ulcerative colitis established by standard clinical, endoscopic, and histologic features at the PROTECT study site
    • Colitis extending beyond the rectosigmoid. If a patient is seriously ill and the clinician does not advance the colonoscopy beyond the sigmoid colon but the clinical condition of the patient highly suggests more extensive disease then that patient is eligible for study.
    • Disease activity by PUCAI of ≥10 at diagnosis
    • No therapy previously initiated to treat the newly diagnosed ulcerative colitis
    • Stool culture negative for routine enteric pathogens (Salmonella, Shigella, Campylobacter, E. coli 0157:H7) and Clostridium difficile toxin
    • Stool study negative for enteric parasites (ova and parasites)
    • Parent/guardian consent and patient assent
    • Ability to remain in follow-up for a minimum of one year from diagnosisFemale patients of child bearing age must have a negative urine pregnancy test and practice acceptable contraception
  • Exclusion Criteria:
    • Clinical, endoscopic, radiologic, or histologic evidence suggesting Crohn’s Disease
    • Evidence of any enteric infection at the time of study entry
    • Use of any previous therapy to treat the newly diagnosed ulcerative colitis
    • Use of any oral CS for non-gastrointestinal indication within the past 4 weeks (e.g., asthma)
    • History of use of IM or anti-TNFα agent for other medical conditions (e.g., juvenile rheumatoid arthritis)
    • Use of Accutane within the past 4 weeks
    • Use of any investigational drug within the past four weeks
    • Use of any 5-aminosalicylate within the past 4 weeks
    • Pregnancy
    • Subjects with poorly controlled medical conditions (e.g. diabetes, congestive heart failure)
    • Proctitis or proctosigmoiditis only on colonoscopic evaluation
    • Chronic renal disease (BUN and serum creatinine >1.5 times the upper normal limit)
    • Hepatic disease (AST or ALP greater than 3 times the upper normal limit in the absence of concomitant liver disease associated with IBD)
    • History of allergy or hypersensitivity to salicylates, aminosalicylates, or any component of the Pentasa capsule.
    • History of coexisting chronic illness or evidence of significant organic or psychiatric disease on medical history or physical examination
    • History or presence of any condition causing malabsorption or an effect on gastrointestinal motility, or history of extensive small bowel resection