Differences in Outcomes Over Time With Exclusive Enteral Nutrition Compared With Steroids in Children With Mild to Moderate Crohn’s Disease: Results From the<i>GROWTH CD</i>Study

Cohen-Dolev, N.; Sładek, M.; Hussey, Séamus; Turner, Dan; Veres, Gábor; Koletzko, Sibylle; Carpi, Javier Martín de; Staiano, Annamaria; Shaoul, Ron; Lionetti, Paolo; Dias, Jorge Amil; Pærregaard, Anders; Nuti, Federica; Gik, Tamar Pfeffer; Ziv‐Baran, Tomer; Shulman, Sivan Ben Avraham; Shabat, Chen Sarbagili; Boneh, Rotem Sigall; Russell, Richard K.; Levine, Arie

doi:10.1093/ecco-jcc/jjx150

Cited by 76 publications

(79 citation statements)

References 19 publications

(27 reference statements)

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“…Other key endpoints including factors determining risk for complications (fibrostenosing disease, penetrating disease and perianal complications), a model for highrisk disease, and the effect of initial treatment on outcomes, form the basis of separate studies of the GROWTH CD cohort, several of which are ongoing or already published and thus are not included. 12,19,20 Patients' characteristics at baseline and 12 weeks after treatment initiation were compared between those who had relapse and those who didn't. Categorical variables were compared using Chi-square test or Fisher's exact test and continuous variables using independent samples ttest or Mann-Whitney test.…”

Section: Discussionmentioning

confidence: 99%

“…The primary endpoint of this aspect of the GROWTH CD study was to determine a model for early relapse (by week 78), based on variables from weeks 0 and 12. Other key endpoints including factors determining risk for complications (fibrostenosing disease, penetrating disease and perianal complications), a model for highrisk disease, and the effect of initial treatment on outcomes, form the basis of separate studies of the GROWTH CD cohort, several of which are ongoing or already published and thus are not included …”

Section: Methodsmentioning

confidence: 99%

“…The design details of the GROWTH CD study have been described previously. 12,14 Briefly, it is a prospective observational study designed to prognosticate paediatric CD in over 300 children from the first 12 weeks of disease. It evaluated treatment-naïve children aged 4-17 years with newly diagnosed CD, from 2010-2013.…”

Section: Patients and Study Designmentioning

confidence: 99%

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Response to treatment is more important than disease severity at diagnosis for prediction of early relapse in new‐onset paediatric Crohn’s disease

Ziv‐Baran¹,

Hussey²,

Sładek

et al. 2018

Aliment Pharmacol Ther

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Summary Background Paediatric Crohn's disease is characteried by frequently relapsing disease which may lead to hospitalisations and complications. Aim To develop predictive models for early relapse following first remission. Methods The GROWTH CD prospective inception cohort was designed to predict risk for early disease relapse and poor outcomes. Newly diagnosed children underwent endoscopies and imaging. They were phenotyped and followed at scheduled visits through 78 weeks for relapses. Twenty‐eight dichotomous and continuous variables were assessed at baseline and week 12, including phenotype, inflammatory markers, disease activity (PCDAI) and other markers. Clinical relapses defined as PCDAI >10 after remission were recorded using a relapse form. Logistic regression & risk modelling was performed. Results We enrolled 282 eligible patients of whom 178 (63.6%) patients achieved steroid free remission by week 12. Disease complications developed in 22/76(29%) of patients with relapse compared to 20/206 (9.7%) without relapse (P = 0.01). Multivariable analysis demonstrated that while variables from age/gender at diagnosis were not predictive, week 12 variables including PCDAI >5 (P = 0.02), CRP >20 mg/L (P = 0.02), and faecal calprotectin >400 µg/g (P = 0.03) as optimal cut‐offs were associated with increased risk of relapse. A prediction model for patients in remission including gender, age, week 12 PCDAI, calprotectin and CRP had sensitivity 43%, specificity 92%, PPV 78%, NPV 71% for relapse. Conclusions Early relapses were associated with a higher risk for disease complications at followup. Relapse prediction based on week 12 disease activity or inflammation is superior to prediction using data from diagnosis.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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Response to treatment is more important than disease severity at diagnosis for prediction of early relapse in new‐onset paediatric Crohn’s disease

Ziv‐Baran¹,

Hussey²,

Sładek

et al. 2018

Aliment Pharmacol Ther

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“…Cohen-Dolev et al demonstrated that EEN was superior to corticosteroids for induction of remission and linear growth in a multicentre prospective inception cohort of mild-to-moderate CD at diagnosis. EEN was not superior with respect to other outcomes such as time to relapse or complications over 2 years 72. Grover et al performed a prospective trial to assess mucosal healing by performing colonoscopy before and after 8 weeks of EEN with azathioprine.…”

Section: Introductionmentioning

confidence: 99%

Evolving role of diet in the pathogenesis and treatment of inflammatory bowel diseases

Levine

Boneh

Wine

2018

Gut

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287

284

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Recent advances in basic and clinical science over the last 3 years have dramatically altered our appreciation of the role of diet in inflammatory bowel diseases (IBD). The marked increase in incidence of these diseases along with the important role of non-genetic susceptibility among patients with IBD has highlighted that these diseases have a strong environmental component. Progress in the field of microbiome and IBD has demonstrated that microbiome appears to play an important role in pathogenesis, and that diet may in turn impact the composition and functionality of the microbiome. Uncontrolled clinical studies have demonstrated that various dietary therapies such as exclusive enteral nutrition and newly developed exclusion diets might be potent tools for induction of remission at disease onset, for patients failing biologic therapy, as a treatment for disease complications and in reducing the need for surgery. We review these advances from bench to bedside, along with the need for better clinical trials to support these interventions.

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“…In adults, several systematic reviews have suggested that there is evidence, albeit weak, that EEN is less effective than conventional treatment with corticosteroids . However, the results from individual studies in children are more supportive of EEN . For example, the results from the GROWTH‐CD study demonstrated that EEN was more effective at inducing remission than corticosteroids and also offered greater benefits in terms of improved growth .…”

Section: Introductionmentioning

confidence: 99%

Inducing remission in paediatric Crohn’s disease using nutritional therapies – A systematic review

McVeigh

Payne

2019

J Human Nutrition Diet

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Background Exclusive enteral nutrition (EEN) is known to be a safe and effective treatment option for managing active Crohn’s disease (CD) in children, although no uniform protocol exists. The aim of this systematic review was to evaluate and compare the clinical effectiveness of aspects of EEN protocols to ascertain whether an optimum regimen can be identified. Methods A systematic search of the Cochrane Library, PubMed, MEDLINE, EMBASE, CINAHL and AMED was conducted for studies published between 1998 and 2018 that examined paediatric patients being treated with an enteral nutrition protocol to induce remission. Studies that included patients receiving concurrent medication for active disease were excluded. Quality assessment was performed using separate tools for randomised controlled trials, cohort studies and for studies without a control group. Results Sixteen studies met the inclusion criteria. Of these, six found insufficient evidence to support use of a specific formula. One study examined the route of EEN, finding no difference between oral or nasogastric tube administration with respect to inducing remission. Three examined the use of partial enteral nutrition to induce remission, although conflicting results were seen. No studies explored the effect of length of treatment or energy prescription on remission rates Conclusions An optimum enteral nutrition protocol for inducing remission cannot be identified. Further focused research is required by well designed, adequately powered prospective clinical trials to examine aspects of enteral feeding protocols that remain uncertain, including the use of partial enteral nutrition as a potential alternative to EEN.

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Differences in Outcomes Over Time With Exclusive Enteral Nutrition Compared With Steroids in Children With Mild to Moderate Crohn’s Disease: Results From theGROWTH CDStudy

Abstract: Use of EEN was associated with higher remission rates and a trend toward better growth but with similar relapse and complication rates in new-onset mild to moderate paediatric CD.

Cited by 76 publications

References 19 publications

Response to treatment is more important than disease severity at diagnosis for prediction of early relapse in new‐onset paediatric Crohn’s disease

Response to treatment is more important than disease severity at diagnosis for prediction of early relapse in new‐onset paediatric Crohn’s disease

Evolving role of diet in the pathogenesis and treatment of inflammatory bowel diseases

Inducing remission in paediatric Crohn’s disease using nutritional therapies – A systematic review

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