Maintenance treatment of Crohn's disease with a polymeric feed rich in TGF-β

Abstract

Rationale: Dietetic intervention with polymeric diet rich in transforming growth factor-β2 (TGF-β2) represents a relatively satisfactory therapeutic modality in adult patients with mild to moderately active Crohn's disease. However, there is no information concerning long-term results of this special diet. The aim of this study was to compare the results of the administration of a special diet (Modulen IBD) rich in TGF-β2 with those of the administration of mesalamine, in maintaining remission in patients with Crohn's disease. Methods: Of the 83 patients initially included in the study, 76 (91.5%) [36 in the Modulen and 30 in the mesalamine arm] completed the trial. Patients were randomly assigned to receive either two meals (2X50g) of Modulen IBD plus two regular meals per day (43 patients) or mesalamine (800mg three times a day) (40 patients) for six months. Patients were assessed at sixth months after initiation of the trial. Relapse was defined as a Crohn's Disease Activity Index of greater than 150 points or at least 60 points over baseline. Various anthropometric parameters and serum estimations including ESR, CRP, platelets, albumin, vitamin B12 and folic acid were carried out at the beginning of the trial and after six months. Results: Twenty-five patients in the Modulen arm (69%) continued to be in remission after six months compared with 18(60%) receiving mesalamine (no significant differences). Among patients with relapse the mean time to relapse was 103 days for those treated with mesalamine and 123 days for those treated with Modulen (no significant differences). Conclusion:Modulen-IBD treatment reduced relapse rate to a better degree compared with mesalamine treatment, although statistical significance was not achieved.