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Background-The relapse rate after steroid induced remission in Crohn's disease is high. Aims-To test whether oral pH modified release budesonide (3 × 1 mg/day) reduces the relapse rate and to identify patient subgroups with an increased risk of relapse. Methods-In a multicentre, randomised, double blind study, 179 patients with steroid induced remission of Crohn's disease received either 3 × 1 mg budesonide (n=84) or placebo (n=95) for one year. The primary study aim was the maintenance of remission of Crohn's disease for one year. Results-Patient characteristics at study entry were similar for both groups. The relapse rate was 67% (56/84) in the budesonide group and 65% (62/95) in the placebo group. The relapse curves in both groups were similar. The mean time to relapse was 93.5 days in the budesonide group and 67.0 days in the placebo group. No prognostic factors allowing prediction of an increased risk for relapse or definition of patient subgroups who derived benefit from low dose budesonide were found. Drug related side eVects were mild and no diVerent between the budesonide and the placebo group. Conclusion-Oral pH modified release budesonide at a dose of 3 × 1 mg/day is not eVective for maintaining steroid induced remission in Crohn's disease. (Gut 1998;42:493-496)

Background-Immunoregulatory abnormalities of T cells might be of importance in the pathogenesis of pouchitis after ileoanal pouch anastomosis (IAP).Aims-To characterise T cell subsets, their state of activation, and production of cytokines in inflamed and non-inflamed pouches in patients with ulcerative colitis (UC) and familial adenomatous polyposis (FAP). The influence of T cell activation on mucosal transformation was also studied. Patients-Mucosal biopsy specimens were taken from 42 patients with IAP (33 with UC and nine with FAP).Methods-Mononuclear cells were isolated by standard techniques and characterised by three colour flow cytometry. Interferon (IFN-) production was studied using the ELISPOT technique.Results-In patients with UC with pouchitis there was a significant increase in the CD4:CD8 ratio, expression of activation markers on CD3+ cells, and number of IFN producing mononuclear cells compared with patients with UC without pouchitis (CD4:CD8 ratio 1.3 (range 0.7-2.7) versus 0.6 (0.1-1.0), p=0.012). In addition, a positive correlation between increased crypt depth and the number of CD4+ cells (r=0.57) was shown. Conclusion-The observed increase in activated mucosal CD4+ T cells and IFNproduction might lead to mucosal destruction and crypt hyperplasia as seen in pouchitis. (Gut 1998;43:499-505)