Randomised, double-blind, placebo-controlled trial of oral budesonide for prophylaxis of acute intestinal graft-versus-host disease after allogeneic stem cell transplantation (PROGAST).

Overall infectious complications showed a trend to a higher frequency in the budesonide group, but gastrointestinal infections were equal in both groups and reflect better potentially side effects of locally acting budesonide.

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The incidence of chronic intestinal GvHD showed a higher percentage in the placebo group (budesonide 6.3% (n = 3), placebo 11.6% (n = 5), but failed to reach significance.

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