Abstract

Introduction: Therapy of active Crohn’s disease (CD) should be aimed at obtaining clinical remission, improving quality of life and healing gut inflammatory lesions. The latter is a critical factor to provide a long term remission. Traditional treatment for active pediatric CD includes corticosteroids or nutritional therapy alone; however, very few studies have compared the two treatment regimens taking into account inflammatory lesions of the gut as documented by endoscopy and histology. Aim of the study was to compare the efficacy of an oral polymeric diet (Modulen), rich in transforming growth factor beta2, versus oral corticosteroids in inducing clinical and inflammatory remission in children with a newly diagnosed or relapsed CD. Methods: Thirty-two patients (pts) were enrolled in a 10 week randomized study: 17 received the polymeric diet alone, 15 were treated with methylprednisolone (1.6 mg/kg/day for 4 weeks, followed by gradual tapering) and azathioprine. Pre-and post-trial evaluation in all pts included PCDAI, ileo-colonoscopy with histology, bioumoral parameters. Endoscopy and histology scores were measured according to methods previously published. Clinical remission was defined by a PCDAI <10, and inflammatory remission as a decrease in both endoscopic and histological scores for > 50 % when compared to baseline. Patients were evaluated by physicians unaware of the therapeutic allocation. Results: There was dramatic improvement in PCDAI both in nutritional group (pre, 37.91±10.32; post, 6.58±5.35, p<0.01) and steroid group (pre, 36.72±8.27; post, 8.72±5.33, p<0.01); however, endoscopic and histologic score significantly decreased only in the nutritional group (endoscopy; pre, 3.58±0.51; post, 1.66±0.49, p<0.01; histology; pre, 10.41±1.72; post, 3.41±0.99, p<0.01), whereas no significantly change occurred in the steroid group (endoscopy; pre, 3.54±0.52; post, 2.69±0.30, NS; histology; pre, 11.09±1.75; post, 8.50±1.54, NS). Inflammatory remission was obtained in 14 pts of nutritional group (82.35%) and only in 6 pts on steroids (40%) (X2: 7.93; p<0.01). Conclusion: In children with active CD, nutritional treatment alone with an oral polymeric diet is efficacious as an oral corti-costeroid course in inducing clinical remission; however, only nutritional therapy is able to promote healing of gut inflammatory lesions as shown by endoscopy and histology. Nutritional therapy alone should be the treatment of choice in children with active CD and can be viewed as a disease-modifying therapy due to mucosal healing properties.

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