High Dose Oral 4-Aminosalicylic Acid (PASER®) to Control Acute Flares of Mild to Moderate Crohn's Disease in Children

Inclusion Criteria: * Age less than 18 years * Crohn's disease predominantly involving the ileum and/or cecum. The diagnosis must have been established by radiography, endoscopy and/or biopsy (at least 2 of the 3 modalities) with at least one confirmatory test having been performed no more than 36 months before entry. The diagnosis must have been confirmed by at least one gastroenterologist. * Harvey Bradshaw Index of at least 7 * The onset of the acute flare should have been abrupt, declaring itself over 72 hours, and should have started no more than 4 weeks before study entry. Symptoms relating to the flare should not have diminished or started to improve prior to entry. * Written informed consent Exclusion Criteria: * Concomitant corticosteroids, budesonide * Corticosteroids within 2 months * Cyclosporine, mycophenolate mofetil or experimental drugs during the last three months * Maintenance infliximab, or infliximab or other biologics in the preceding 3 months * If the severity of the flare has started to decrease spontaneously * Coexisting diagnosis of primary sclerosing cholangitis * Infectious diarrhea * Signs of intestinal obstruction or perforation * New fistulization as part of the acute flare or increased activity in chronic fistula(e) as part of the acute flare * Hypersensitivity to 4-ASA or any components of PASER® * Pregnancy or breast-feeding * Failure of a woman of child-bearing potential to agree to use adequate contraception for the 4 week period of the trial, if sexually active * Severe renal or hepatic disease (i.e., more than 3 times upper limit of normal) or a WBC \< 3,000 during the preceding three months