TY - JOUR
T1 - Dietary Therapies Induce Rapid Response and Remission in Pediatric Patients With Active Crohn's Disease
AU - Sigall Boneh, Rotem
AU - van Limbergen, Johan
AU - Wine, Eytan
AU - Assa, Amit
AU - Shaoul, Ron
AU - Milman, Peri
AU - Cohen, Shlomi
AU - Kori, Michal
AU - Peleg, Sarit
AU - On, Avi
AU - Shamaly, Hussein
AU - Abramas, Lee
AU - Levine, Arie
N1 - Funding Information: Conflicts of interest These authors disclose the following: RSB reports personal fees from Consulting to Nestle Health Science during the conduct of the study; personal fees from Invited speaker by Nestle Health Science; and personal fees from Invited speaker by Takeda, outside the submitted work. JVL reports consulting, travel, and/or speaker fees and research support from AbbVie, Janssen, Nestlé Health Science, Merck, Novalac, P&G, GSK, Illumina, and Otsuka. EW reports personal fees from Janssen, personal fees from AbbVie, and personal fees from Nestle Health Science outside the submitted work. AA reports consultation and lectures fees from AbbVie and research grants from AbbVie and Janssen. RS reports personal fees from Janssen, AbbVie, Mead Johnsson, Lapidot, and Abbott outside the submitted study. AL reports grants from Nestle Health Science and grants from Janssen unrelated to this field; advisory boards, travel, speaker fees, or DSMBs from Celgene, Takeda, and AbbVie, and a licensing and consulting agreement with IP with Nestle Health to develop new products based on diet. The remaining authors disclose no conflicts. Funding Information: Funding Initial funding for the study in Israel was provided by unrestricted grants from the Azrieli Foundation and Nestlé Health Science to AL. Nestlé Health Science provided Modulen to all participating sites to ensure uniformity of the formula used among participants and provided the formula to enrolled patients for the duration of the study. The conduct of the study in Canada (Halifax, Edmonton) was supported by local divisional funds, a Women and Children’s Health Research Institute (WCHRI) Research Capacity Building Award (EW), and a Canadian Institutes of Health Research (CIHR) New Investigator award (JVL) and Canada Research Chair Tier 2 in Translational Microbiomics (JVL). Publisher Copyright: © 2021 AGA Institute
PY - 2021/4
Y1 - 2021/4
N2 - Background & Aims: Dietary therapies based on exclusion of usual dietary elements induce remission in children with Crohn's disease (CD), whereas re-exposure induces rebound inflammation. We investigated whether a short trial of dietary therapy, to identify patients with and without a rapid response or remission on the diet (DiRe), can be used to predict success or failure of long-term dietary therapy. Methods: We collected data from the multicenter randomized trial of the CD exclusion diet (CDED). We analyzed data from 73 children with mild to moderate CD (mean age, 14.2 ± 2.7 y) randomly assigned to groups given either exclusive enteral nutrition (EEN, n = 34) or the CDED with 50% (partial) enteral nutrition (n = 39). Patients were examined at baseline and at weeks 3 and 6 of the diet. Remission was defined as CD activity index scores below 10 and response was defined as a decrease in score of 12.5 points or clinical remission. Inflammation was assessed by measurement of C-reactive protein. Results: At week 3 of the diet, 82% of patients in the CDED group and 85% of patients in the EEN group had a DiRe. Median serum levels of C-reactive protein had decreased from 24 mg/L at baseline to 5.0 mg/L at week 3 (P <.001). Among the 49 patients in remission at week 6, 46 patients (94%) had a DiRe and 81% were in clinical remission by week 3. In multivariable analysis, remission at week 3 increased odds of remission by week 6 (odds ratio, 6.37; 95% CI, 1.6–25; P =.008) whereas poor compliance reduced odds of remission at week 6 (odds ratio, 0.75; 95% CI, 0.012–0.46; P =.006). Conclusions: For pediatric patients with active CD, dietary therapies (CDED and EEN) induce a rapid clinical response (by week 3). Identification of patients with and without a rapid response to diet might help identify those who, with compliance, will be in clinical remission by week 6 of the diet. ClinicalTrials.gov no: NCT01728870
AB - Background & Aims: Dietary therapies based on exclusion of usual dietary elements induce remission in children with Crohn's disease (CD), whereas re-exposure induces rebound inflammation. We investigated whether a short trial of dietary therapy, to identify patients with and without a rapid response or remission on the diet (DiRe), can be used to predict success or failure of long-term dietary therapy. Methods: We collected data from the multicenter randomized trial of the CD exclusion diet (CDED). We analyzed data from 73 children with mild to moderate CD (mean age, 14.2 ± 2.7 y) randomly assigned to groups given either exclusive enteral nutrition (EEN, n = 34) or the CDED with 50% (partial) enteral nutrition (n = 39). Patients were examined at baseline and at weeks 3 and 6 of the diet. Remission was defined as CD activity index scores below 10 and response was defined as a decrease in score of 12.5 points or clinical remission. Inflammation was assessed by measurement of C-reactive protein. Results: At week 3 of the diet, 82% of patients in the CDED group and 85% of patients in the EEN group had a DiRe. Median serum levels of C-reactive protein had decreased from 24 mg/L at baseline to 5.0 mg/L at week 3 (P <.001). Among the 49 patients in remission at week 6, 46 patients (94%) had a DiRe and 81% were in clinical remission by week 3. In multivariable analysis, remission at week 3 increased odds of remission by week 6 (odds ratio, 6.37; 95% CI, 1.6–25; P =.008) whereas poor compliance reduced odds of remission at week 6 (odds ratio, 0.75; 95% CI, 0.012–0.46; P =.006). Conclusions: For pediatric patients with active CD, dietary therapies (CDED and EEN) induce a rapid clinical response (by week 3). Identification of patients with and without a rapid response to diet might help identify those who, with compliance, will be in clinical remission by week 6 of the diet. ClinicalTrials.gov no: NCT01728870
KW - Child
KW - Crohn Disease
KW - Crohn Disease Exclusion Diet
KW - Diet
KW - Emulsifiers
KW - Exclusive Enteral Nutrition
KW - Food
KW - High Fat Diet
KW - Nutrients
KW - Pediatric IBD
KW - Processed Food
KW - Response to Treatment
KW - Western Diet
UR - http://www.scopus.com/inward/record.url?scp=85101332952&partnerID=8YFLogxK
U2 - https://doi.org/10.1016/j.cgh.2020.04.006
DO - https://doi.org/10.1016/j.cgh.2020.04.006
M3 - Article
C2 - 32302709
SN - 1542-3565
VL - 19
SP - 752
EP - 759
JO - Clinical Gastroenterology and Hepatology
JF - Clinical Gastroenterology and Hepatology
IS - 4
ER -