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OP05 Crohn’s disease exclusion diet is equally effective but better tolerated than exclusive enteral nutrition for induction of remission in mild-to-moderate active paediatric Crohn’s disease: a prospective randomised controlled trial

J. Van Limbergen1,2, E. Wine3, A. Assa4, R. Sigall Boneh5, R. Shaoul6, M. Kori7, S. Cohen8, S. Peleg9, H. Shamaly10, A. On11, P. Milman12, L. Abramas5, T. Ziv Baran13, S. Grant14, A. Levine*5,13

1Dalhousie University, Halifax, Canada, 2IWK Center, Halifax, Canada, 3University Alberta, Edmonton, Canada, 4Schneider Medical Center, Petach Tikva, Israel, 5Wolfson Medical Center, Holon, Israel, 6Meyer Hospital, Haifa, Israel, 7Kaplan Hospital, Rehovot, Israel, 8Dana Childrens Hospital, Tel Aviv, Israel, 9HaEmek Hospital, Afula, Israel, 10French Hospital, Nazareth, Israel, 11Poriah Hospital, Tiberias, Israel, 12Hadassah Hospital, Jerusalem, Israel, 13Tel Aviv University, Tel Aviv, Israel, 14Mount Saint Vincent University, Halifax, Canada

Background

Exclusive enteral nutrition (EEN; consumption of a liquid formula without other food for 6–8 weeks) is the recommended first-line therapy for induction of remission in children with mild-to-moderate Crohn’s disease (CD). The CD exclusion diet (CDED) is a whole food diet coupled with partial enteral nutrition (PEN), designed to reduce exposure to dietary components hypothesised to negatively affect the microbiome, intestinal barrier, and innate immunity.

Methods

The CDED study was a 12-week prospective, international, multi-centre RCT in children with mild-to-moderate luminal CD <3 years comparing CDED to EEN. Children aged 6–18 years with a paediatric CD activity index (PCDAI) ≥10, + elevated inflammatory markers, were randomised to one of the two groups: Group 1, CDED Stage 1 diet + 50% calories from PEN (Modulen, Nestle) for 6 weeks, followed by CDED Stage 2 + 25% PEN for the next 6 weeks; Group 2 EEN for 6 weeks (Modulen) followed by 6 weeks of free diet with 25% supplemental calories from PEN. The primary endpoint was tolerance to diet, measured by withdrawals for refusal to continue diet and poor adherence (measured by a modified MARS questionnaire and physician’s assessment). Secondary endpoints included Week 6 intention to treat (ITT) remission defined by PCDAI ≤10 but also with the more stringent definition (PCDAI < 10), and corticosteroid (CS) free ITT sustained remission Week 12.

Results

Seventy-eight patients meeting inclusion exclusion criteria were randomised to CDED+PEN (40)or to EEN (38), four withdrew because of intolerance to diet by 48 h (all EEN). Seventy-four remaining patients (mean age 14.2 ± 2.7 years) were included in the remission analysis. Median PCDAI at baseline was 25 (IQR 20–35) for CDED and 27.5 (IQR 18.75–32.5) in EEN; p = 0.89. Tolerance was present in 39/40 (97.5%) CDED and in 28/38(73.7%) EEN (p = 0.003). Poor compliance was similar [7/40 (17.5%) vs. 8/34 (23.5%); p = 0.52]. Week 6 ITT CS-free remission PCDAI ≤10 occurred in 32/40 (80%) in CDED vs. 25/34 (73.5%) with EEN (p = 0.51). Using the more stringent PCDAI < 10, remission was 30/40(75%) CDED and 20/34 (59%) EEN p = 0.38. Median CRP decreased from Week 0 to 6 in both groups (23.6 to 5 g/l with CDED; p < 0.001; 24 to 4 g/l with EEN; p < 0.001). Sustained CS free remission at Week 12 PCDAI ≤10 was 28/40 (70%) with CDED+PEN and 14/34 (41.2%), in the EEN followed by PEN +free diet p = 0.01.

Conclusion

Both diets result in high rates of ITT CS free remission with a significant decrease in inflammation. CDED with PEN has superior tolerance and sustained remission by Week 12. These data support the use of CDED+PEN as a first-line therapy for children with luminal mild-to-moderate active CD. They also support the concept that diet plays a role in inflammation in CD