P216 Effect of the Crohn’s disease exclusion diet (CDED) on the fecal calprotectin level in children with active Crohn’s disease.

Matuszczyk, M.(1);Meglicka, M.(1);Wiernicka, A.(1);Jarzebicka, D.(1);Osiecki, M.(1);Kotkowicz-Szczur, M.(1);Kierkus, J.(1);

(1)The Children's Memorial Health Institute, Department of Gastroenterology- Hepatology- Feeding Disorders and Pediatrics, Warsaw, Poland;

Background

The CDED + PEN (partial enteral nutrition) is a promising method of nutritional treatment in active Crohn's disease (CD). An increase of fecal calprotectin (FCP) level - a marker of mucosal inflammation – happens to be the first evidence of the Crohn's disease exacerbation, ahead of clinical symptoms, and usually accompanies clinical symptoms. In this study we present our own experience with using the CDED + PEN in treatment of children with CD and higher FCP level.

Methods

Forty eight children (male/female: 27/21) in age 4-18 years (median value = 13.6; IQR=3.7) were treated with CDED + PEN. The main inclusion criteria to the study was active CD defined as FCP level ≥ 250 µg/g. Patients with severe clinical manifestation of CD (PCDAI >40) or who started any new concomitant CD’s treatment together with the dietary intervention were excluded from the analysis. The PCDAI and fecal calprotectin level were assessed at week 0 and 12. The primary endpoint was ITT normalization of FCP level that is result< 250 µg/g at week 12. Wilcoxon Matched Pairs Test was used for statistical analysis.

Results

The normalization of FCP level was obtained in 35 % (17) of children and the minimum 50% decrease of FCP level in 56% (27). The reduction of fecal calprotectin level between week 0 and week 12 was statistically significant with median value = 1045 µg/g; IQR=1188 and 363 µg/g; IQR=665, respectively (p<0.05). In the group of 29 patients who were not in clinical remission (PCDAI≥10) at baseline 16 (55%) obtained clinical remission (PCDAI<10) at week 12 and 20 (69%) clinical response defined as a drop in PCDAI of at least 12.5 points or PCDAI<10 points. The reduction of PCDAI between baseline and week 12 was statistically significant (median value  = 20 points; IQR=7.5 and 5 points; IQR=6.2, respectively (p<0.05)). All patients with normal FCP level at week 12 were in clinical remission. In 10 children (21%) the full course of 12 weeks with CDED+PEN was not completed or the concomitant therapy had been started before week 12 due to the lack of efficacy/ intolerance of nutritional treatment.

Conclusion

The 12-weeks course of treatment with the CDED + PEN has a beneficial effect on the fecal calprotectin level in children with active CD. Dietary intervention leaded to significant decrease in the FCP level in studied group and to the normalization of this parameter in every third patient.