Crohn's Disease Exclusion Diet Plus Partial Enteral Nutrition Induces Sustained Remission in a Randomized Controlled Trial
| Autor: | Joseph P. Bielawski, Katherine A. Dunn, Michal Kori, Hussein Shamaly, Lee Abramas, Sarit Peleg, Johan Van Limbergen, Rotem Sigall Boneh, Eytan Wine, Tomer Ziv-Baran, Shannan Grant, Guila Abitbol, Ron Shaoul, Amit Assa, Peri Millman, Avi On, Arie Levine, Shlomi Cohen |
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| Přispěvatelé: | Paediatric Gastroenterology, AGEM - Amsterdam Gastroenterology Endocrinology Metabolism |
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
Male
0301 basic medicine medicine.medical_specialty Adolescent Severity of Illness Index Gastroenterology law.invention 03 medical and health sciences Enteral Nutrition 0302 clinical medicine Crohn Disease Randomized controlled trial law Internal medicine Severity of illness Clinical endpoint Humans Medicine Prospective Studies Child Adverse effect Prospective cohort study 2. Zero hunger Intention-to-treat analysis Hepatology biology business.industry Remission Induction C-reactive protein Combined Modality Therapy 3. Good health Treatment Outcome 030104 developmental biology Parenteral nutrition biology.protein Female 030211 gastroenterology & hepatology business Diet Therapy |
| Zdroj: | Gastroenterology, 157(2), 440-450.e8. W.B. Saunders Ltd |
| ISSN: | 0016-5085 |
| Popis: | Background & Aims Exclusive enteral nutrition (EEN) is recommended for children with mild to moderate Crohn’s disease (CD), but implementation is challenging. We compared EEN with the CD exclusion diet (CDED), a whole-food diet coupled with partial enteral nutrition (PEN), designed to reduce exposure to dietary components that have adverse effects on the microbiome and intestinal barrier. Methods We performed a 12-week prospective trial of children with mild to moderate CD. The children were randomly assigned to a group that received CDED plus 50% of calories from formula (Modulen, Nestle) for 6 weeks (stage 1) followed by CDED with 25% PEN from weeks 7 to 12 (stage 2) (n = 40, group 1) or a group that received EEN for 6 weeks followed by a free diet with 25% PEN from weeks 7 to 12 (n = 38, group 2). Patients were evaluated at baseline and weeks 3, 6, and 12 and laboratory tests were performed; 16S ribosomal RNA gene (V4V5) sequencing was performed on stool samples. The primary endpoint was dietary tolerance. Secondary endpoints were intention to treat (ITT) remission at week 6 (pediatric CD activity index score below 10) and corticosteroid-free ITT sustained remission at week 12. Results Four patients withdrew from the study because of intolerance by 48 hours, 74 patients (mean age 14.2 ± 2.7 years) were included for remission analysis. The combination of CDED and PEN was tolerated in 39 children (97.5%), whereas EEN was tolerated by 28 children (73.6%) (P = .002; odds ratio for tolerance of CDED and PEN, 13.92; 95% confidence interval [CI] 1.68–115.14). At week 6, 30 (75%) of 40 children given CDED plus PEN were in corticosteroid-free remission vs 20 (59%) of 34 children given EEN (P = .38). At week 12, 28 (75.6%) of 37 children given CDED plus PEN were in corticosteroid-free remission compared with 14 (45.1%) of 31 children given EEN and then PEN (P = .01; odds ratio for remission in children given CDED and PEN, 3.77; CI 1.34–10.59). In children given CDED plus PEN, corticosteroid-free remission was associated with sustained reductions in inflammation (based on serum level of C-reactive protein and fecal level of calprotectin) and fecal Proteobacteria. Conclusion CDED plus PEN was better tolerated than EEN in children with mild to moderate CD. Both diets were effective in inducing remission by week 6. The combination CDED plus PEN induced sustained remission in a significantly higher proportion of patients than EEN, and produced changes in the fecal microbiome associated with remission. These data support use of CDED plus PEN to induce remission in children with CD. Clinicaltrials.gov no: NCT01728870 . |
| Databáze: | OpenAIRE |
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