Scientific Evidence & Methodology

This selection includes trials, observational studies, reviews, guidelines and technical data. Each source has a defined scope; citing it does not replace clinical validation of the calculator or review of meal-plan portions.

1. 1

   Levine A, Wine E, Assa A, et al. Crohn's Disease Exclusion Diet Plus Partial Enteral Nutrition Induces Sustained Remission in a Randomized Controlled Trial. Gastroenterology. 2019;157(2):440-450.e8.PMID: 31170412

   12-week induction trial of CDED+PEN (50% for the first 6 weeks; 25% thereafter). It does not by itself validate the subsequent long-term maintenance phase. Efficacy (mild-to-moderate paediatric CD): week-6 remission without a statistically significant difference versus EEN (75% vs 59%; p=0.38) and superior corticosteroid-free sustained remission at week 12 (75.6% vs 45.1%; p=0.01), with better tolerance (97.5% vs 73.6%).

2. 2

   Yanai H, Levine A, Hirsch A, et al. The Crohn's disease exclusion diet for induction and maintenance of remission in adults with mild-to-moderate Crohn's disease (CDED-AD): an open-label, pilot, randomised trial. Lancet Gastroenterol Hepatol. 2022;7(1):49-59.PMID: 34739863

   CDED-AD trial (open-label, pilot) extending the CDED protocol to adults with mild-to-moderate CD. Lower-grade evidence: underpowered, with no significant difference between CDED+PEN and CDED without PEN at week 6 (68% vs 57%; p=0.46). Suggests efficacy in adults but needs confirmation in an adequately powered RCT.

3. 3

   Sigall Boneh R, et al. Dietary Therapy With the Crohn's Disease Exclusion Diet Is a Successful Strategy for Induction of Remission in Children and Adults Failing Biological Therapy. J Crohns Colitis. 2017;11(10):1205-1212.PMID: 28525622

   Single-centre experience in 21 children and adults with loss of response to biologics. It describes remission after CDED + PEN without a comparator group; this is exploratory evidence, not definitive validation of the strategy.

4. 4

   Niseteo T, Sila S, Trivić I, Mišak Z, Kolaček S, Hojsak I. Modified Crohn's disease exclusion diet is equally effective as exclusive enteral nutrition: Real-world data. Nutr Clin Pract. 2022;37(2):435-441.PMID: 34339527

   Retrospective paediatric study comparing modified CDED + PEN with EEN; most participants in the first group initially received 1–2 weeks of EEN. Finding no significant difference in remission does not establish equivalence. This study does not validate the menus created for IBDNutrition.

5. 5

   Borrelli O, Cordischi L, Cirulli M, et al. Polymeric Diet Alone Versus Corticosteroids in the Treatment of Active Pediatric Crohn's Disease: A Randomized Controlled Open-Label Trial. Clin Gastroenterol Hepatol. 2006;4(6):744-753.PMID: 16682258

   Landmark paediatric RCT establishing polymeric EEN as an effective alternative to corticosteroids in active CD, with superior mucosal healing. Historical basis for EEN as induction therapy in paediatrics.

6. 6

   Ruemmele FM, et al. (ECCO/ESPGHAN). Consensus guidelines of ECCO/ESPGHAN on the medical management of paediatric Crohn's disease. J Crohns Colitis. 2014;8(10):1179-1207.PMID: 24909831

   Historical guideline recommending EEN to induce remission in active luminal paediatric CD. It is not presented as validation of the calculator’s specific activity and repletion factors: these are separate adjustments requiring individual assessment.

7. 7

   van Rheenen PF, Aloi M, Assa A, et al. (ECCO-ESPGHAN). The Medical Management of Paediatric Crohn's Disease: an ECCO-ESPGHAN Guideline Update. J Crohns Colitis. 2021;15(2):171-194.PMID: 33026087

   2021 update of the ECCO/ESPGHAN paediatric guidelines: confirms EEN as first-line therapy in low-risk paediatric CD and reaffirms the role of partial enteral nutrition in maintenance.

8. 8

   Bischoff SC, Bager P, Escher J, et al. (ESPEN). ESPEN guideline on Clinical Nutrition in inflammatory bowel disease. Clin Nutr. 2023;42(3):352-379.PMID: 36739756

   Caloric requirements in adult CD: 30–35 kcal/kg/day (Rec. 6; individualise). Protein 1.2–1.5 g/kg/d during active disease. A reference for IBDNutriCalc’s weight-based option; it does not validate every selectable app value.

9. 9

   Torres J, Bonovas S, Doherty G, et al. (ECCO). ECCO Guidelines on Therapeutics in Crohn's Disease: Medical Treatment. J Crohns Colitis. 2020;14(1):4-22.PMID: 31711158

   ECCO 2020 guideline on medical treatment of CD, developed using GRADE. Retained as a historical therapeutic framework, not as the source of a specific enteral nutrition regimen or the platform’s meal plans.

10. 10

    Lamb CA, Kennedy NA, Raine T, et al. (BSG). British Society of Gastroenterology consensus guidelines on the management of inflammatory bowel disease in adults. Gut. 2019;68(Suppl 3):s1-s106.PMID: 31562236

    BSG 2019 IBD management guidelines: 168 evidence- and multidisciplinary-consensus-based recommendations, including nutritional interventions.

11. 11

    Roza AM, Shizgal HM. The Harris Benedict equation reevaluated: resting energy requirements and the body cell mass. Am J Clin Nutr. 1984;40(1):168-182.PMID: 6741850

    Revision of the Harris-Benedict coefficients (1984): this is the version implemented in IBDNutriCalc, not the 1919 original. The equation estimates resting energy expenditure; it does not measure individual requirements.

12. 12

    Mifflin MD, St Jeor ST, Hill LA, et al. A new predictive equation for resting energy expenditure in healthy individuals. Am J Clin Nutr. 1990;51(2):241-247.PMID: 2305711

    Mifflin-St Jeor equation for adult REE estimation, developed in healthy individuals. A selectable option in IBDNutriCalc; it does not constitute specific validation in CD.

13. 13

    WHO/FAO/UNU. Energy and protein requirements. WHO Tech Rep Ser 724. Geneva: WHO, 1985.

    Source of the FAO/WHO/UNU 1985 coefficients used in IBDNutriCalc’s paediatric option, derived from Schofield data. Implementation is not clinical validation of the calculator; see Methodology for age and scope limits.

14. 14

    FAO/WHO/UNU. Human energy requirements. FAO Food and Nutrition Technical Report Series 1. Rome: FAO, 2004 (consulta de 2001).

    Conceptual PAL framework. The publication uses 1.40–1.69 for sedentary/light activity; the app’s 1.2–1.5 scale is an operational adaptation, not a literal FAO recommendation for IBD.

15. 15

    de Onis M, Onyango AW, Borghi E, et al. Development of a WHO growth reference for school-aged children and adolescents. Bull World Health Organ. 2007;85(9):660-667.PMID: 18026621

    WHO 2006/2007 LMS tables for BMI-for-age Z-score calculation in paediatrics (clinical warning in IBDNutriCalc when Z > +2).

16. 16

    — Ficha técnica de la fórmula enteral específica TGF-β2 utilizada (verificar la del producto comercial concreto).

    Reference reconstitution data used in the calculator: 1 scoop = 8.3 g = 41.5 kcal; can = 400 g; densities 1.0 / 1.25 / 1.5 kcal/ml. Verify exact figures in the technical data sheet of the specific commercial product.

17. 17

    Correia I, Oliveira PA, Antunes ML, et al. Is There Evidence of Crohn's Disease Exclusion Diet (CDED) in Remission of Active Disease in Children and Adults? A Systematic Review. Nutrients. 2024;16(7):987.PMID: 38613020

    Systematic review of CDED + PEN for remission induction in children and adults with active CD. It describes promising results and better tolerance than EEN in the reviewed studies, while calling for further research. It synthesises published protocols; it does not validate the menus or calculator in IBDNutrition.

18. 18

    Zhang JL, Vootukuru N, Niewiadomski O. The effect of solid food diet therapies on the induction and maintenance of remission in Crohn's disease: a systematic review. BMC Gastroenterol. 2024;24(1):250.PMID: 39107691

    Systematic review of solid-food diet therapies (CDED, Mediterranean): promising induction and maintenance results in mild-to-moderate CD, tempered by small studies and moderate-to-high risk of bias.

19. 19

    Jamal F, Alatout MH, Khan MA, et al. The Role of Diet in Crohn's Disease: From Etiology to Evidence-Based Management. Cureus. 2025;17(6):e86891.PMID: 40726853

    Narrative review: Western dietary pattern and ultra-processed foods/additives-emulsifiers linked to dysbiosis and barrier dysfunction; Mediterranean diet and nutritional therapies (EEN, CDED) show benefit. Provides mechanistic context for the exclusion rationale.

20. 20

    Sigall Boneh R, Navas-López VM, Hussey S, et al. Modified Crohn's Disease Exclusion Diet Maintains Remission in Pediatric Crohn's Disease: Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2025;23(11):2001-2011. Publicación electrónica: 26-12-2024.PMID: 39732356

    Multicenter RCT (DIETOMICS-CD; underpowered by COVID) extending CDED evidence to maintenance: 2 weeks of EEN with a polymeric enteral formula followed by CDED+PEN maintained corticosteroid-free remission to week 24 in most patients (60% vs 42% in the initial EEN followed by PEN and free diet group at week 24; P=.18, no significant difference), with better BMI Z-score. Maintenance reference for Phase 3, beyond week 12 of Levine 2019.