Rotem Sigall Boneh1, Johan Van Limbergen2, Eytan Wine3, Amit Assa4, Ron Shaoul5, Peri Milman6, Shlomi Cohen7, Michal Kori8, Sarit Peleg9, Avi On10, Hussein Shamaly11, Lee Abramas12, Arie Levine13. 1. Wolfson Medical Center, Pediatric Gastroenterology, Holon, Israel; The Sackler Faculty of medicine, Tel Aviv University, Tel Aviv, Israel. 2. Emma Children's Hospital, Amsterdam University Medical Centers - location AMC, Amsterdam, the Netherlands. 3. University of Alberta, Edmonton, Alberta, Canada. 4. The Sackler Faculty of medicine, Tel Aviv University, Tel Aviv, Israel; Schneider Hospital, Petach Tikva, Israel. 5. Meyer Hospital, Haifa, Israel. 6. Hadassah Hospital, Jerusalem, Israel. 7. "Dana-Dwek" Children's Hospital, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel. 8. Kaplan Hospital, Rehovot, Israel. 9. HaEmek Hospital, Afula, Israel. 10. Poriah Hospital, Tiberias, Israel. 11. French Hospital, Nazareth, Israel. 12. Wolfson Medical Center, Pediatric Gastroenterology, Holon, Israel. 13. Wolfson Medical Center, Pediatric Gastroenterology, Holon, Israel; The Sackler Faculty of medicine, Tel Aviv University, Tel Aviv, Israel. Electronic address: arie.levine.dr@gmail.com.
Abstract
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.
RCT Entities:
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.
Authors: James D Lewis; Robert S Sandler; Carol Brotherton; Colleen Brensinger; Hongzhe Li; Michael D Kappelman; Scott G Daniel; Kyle Bittinger; Lindsey Albenberg; John F Valentine; John S Hanson; David L Suskind; Andrea Meyer; Charlene W Compher; Meenakshi Bewtra; Akriti Saxena; Angela Dobes; Benjamin L Cohen; Ann D Flynn; Monika Fischer; Sumona Saha; Arun Swaminath; Bruce Yacyshyn; Ellen Scherl; Sara Horst; Jeffrey R Curtis; Kimberly Braly; Lisa Nessel; Maureen McCauley; Liam McKeever; Hans Herfarth Journal: Gastroenterology Date: 2021-05-27 Impact factor: 33.883