The lancet. Gastroenterology & hepatology · 2026
Cyclic exclusive enteral nutrition versus partial enteral nutrition to maintain long-term drug-free remission in paediatric Crohn's disease (CD-HOPE): an open-label, endpoint-blinded, randomised controlled trial.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеСравнительное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Pigneur Bénédicte, Martinez-Vinson Christine, Bourmaud Aurélie, Dabadie Alain, Duclaux-Loras Rémi, Hugot Jean-Pierre, Roman Céline, Dumant Clémentine, Spyckerelle Claire, Guinard-Samuel Vincent, Willot Stéphanie, Dupont Claire, Breton Anne, Caron Nicolas, Chaillou Emilie, Rebouissoux Laurent, Bertrand Valérie, Triolo Valérie, Pages Justine, Djeddi Djamal, Bonneton Marjorie, Uhlen Stéphanie, Catteau Natacha, Coopman Stéphanie, Lepage Patricia, Viala Jérôme, Ruemmele Frank M
Аннотация
BACKGROUND: For children with Crohn's disease, there is a marked demand for long-term nutritional treatment strategies to avoid the side-effects related to drug treatment. We aimed to investigate whether paediatric patients with Crohn's disease responding to nutritional induction therapy can be maintained in remission on dietary therapy without the use of medication or surgery.
METHODS: In this open-label, endpoint-blinded, randomised controlled trial (CD-HOPE) done in 21 hospitals of the GETAID pédiatrique network in France, eligible patients were aged 6 years to younger than 18 years with Crohn's disease (newly diagnosed or relapsing after drug treatment) who had reached clinical remission (weighted Paediatric Crohn's Disease Activity Index [wPCDAI] ≤12·5) after induction therapy with 6-12 weeks of exclusive enteral nutrition (EEN; 100% of calories). Stratified by age (≤10 years or >10 years) and relapse status, patients were randomly assigned (1:1) using block randomisation to receive either cyclic EEN (C-EEN; 100% of daily caloric requirements) for 2 weeks every 8 weeks for at least six cycles or daily partial enteral nutrition (PEN; 25% of daily caloric requirements) for 52 weeks. Oral MODULEN IBD was used for both. Except for the 2-week intervals of EEN in the C-EEN group, food access was not restricted. The primary endpoint was relapse rate at 12 months. A relapse was defined as: (1) a wPCDAI score greater than 12·5 at two successive visits, or (2) a wPCDAI greater than 12·5 once and the need for Crohn's disease-related surgery, medication, or study exit, or (3) a wPCDAI score continuously greater than 12·5 since the last study visit, or (4) incomplete wPCDAI and moderate or severe Physician Global Assessment at any timepoint. Primary and safety analyses were performed on an intention-to-treat basis. This trial was registered on ClinicalTrials.gov (NCT02201693) and is complete.
FINDINGS: Between Dec 12, 2014, and Sept 4, 2018 (last patient visit Oct 2, 2019), 112 patients were screened and 100 patients (70 boys and 30 girls) were randomly assigned to C-EEN (n=49) or PEN (n=51). Median age of participants was 12 years (IQR 11-13) in the C-EEN group and 13 years (11-14) in the PEN group. At 12 months, 24 (49%) of 49 patients had relapsed on C-EEN compared with 39 (76%) of 51 patients on PEN (adjusted odds ratio 0·29 [95% CI 0·13-0·70], p=0·0051). 19 adverse events occurred in 17 patients: four serious adverse events in four patients on PEN, not related to treatment, and 15 non-serious adverse events in 13 patients (nine in seven patients on C-EEN and six in six patients on PEN). The serious adverse events were all related to Crohn's disease relapse requiring hospitalisation for rescue therapy. Six adverse events were possibly related to study treatment: one patient in the C-EEN group reported transient vomiting and diarrhoea at the start of the first EEN cycle, one patient in the C-EEN group developed anorexia and, in the PEN group, four patients reported either weight loss, nausea, Crohn's disease relapse, or skin infection. No malignancy or death was reported in this study.
INTERPRETATION: C-EEN was superior to PEN in maintaining clinical remission over 1 year in paediatric patients with Crohn's disease responding to EEN induction therapy. These findings suggest a new way to use nutritional therapy for maintaining drug-free long-term remission in patients with Crohn's disease who are responding to EEN induction therapy.
FUNDING: Assistance Publique-Hôpitaux de Paris and Nestlé Health Science.
METHODS: In this open-label, endpoint-blinded, randomised controlled trial (CD-HOPE) done in 21 hospitals of the GETAID pédiatrique network in France, eligible patients were aged 6 years to younger than 18 years with Crohn's disease (newly diagnosed or relapsing after drug treatment) who had reached clinical remission (weighted Paediatric Crohn's Disease Activity Index [wPCDAI] ≤12·5) after induction therapy with 6-12 weeks of exclusive enteral nutrition (EEN; 100% of calories). Stratified by age (≤10 years or >10 years) and relapse status, patients were randomly assigned (1:1) using block randomisation to receive either cyclic EEN (C-EEN; 100% of daily caloric requirements) for 2 weeks every 8 weeks for at least six cycles or daily partial enteral nutrition (PEN; 25% of daily caloric requirements) for 52 weeks. Oral MODULEN IBD was used for both. Except for the 2-week intervals of EEN in the C-EEN group, food access was not restricted. The primary endpoint was relapse rate at 12 months. A relapse was defined as: (1) a wPCDAI score greater than 12·5 at two successive visits, or (2) a wPCDAI greater than 12·5 once and the need for Crohn's disease-related surgery, medication, or study exit, or (3) a wPCDAI score continuously greater than 12·5 since the last study visit, or (4) incomplete wPCDAI and moderate or severe Physician Global Assessment at any timepoint. Primary and safety analyses were performed on an intention-to-treat basis. This trial was registered on ClinicalTrials.gov (NCT02201693) and is complete.
FINDINGS: Between Dec 12, 2014, and Sept 4, 2018 (last patient visit Oct 2, 2019), 112 patients were screened and 100 patients (70 boys and 30 girls) were randomly assigned to C-EEN (n=49) or PEN (n=51). Median age of participants was 12 years (IQR 11-13) in the C-EEN group and 13 years (11-14) in the PEN group. At 12 months, 24 (49%) of 49 patients had relapsed on C-EEN compared with 39 (76%) of 51 patients on PEN (adjusted odds ratio 0·29 [95% CI 0·13-0·70], p=0·0051). 19 adverse events occurred in 17 patients: four serious adverse events in four patients on PEN, not related to treatment, and 15 non-serious adverse events in 13 patients (nine in seven patients on C-EEN and six in six patients on PEN). The serious adverse events were all related to Crohn's disease relapse requiring hospitalisation for rescue therapy. Six adverse events were possibly related to study treatment: one patient in the C-EEN group reported transient vomiting and diarrhoea at the start of the first EEN cycle, one patient in the C-EEN group developed anorexia and, in the PEN group, four patients reported either weight loss, nausea, Crohn's disease relapse, or skin infection. No malignancy or death was reported in this study.
INTERPRETATION: C-EEN was superior to PEN in maintaining clinical remission over 1 year in paediatric patients with Crohn's disease responding to EEN induction therapy. These findings suggest a new way to use nutritional therapy for maintaining drug-free long-term remission in patients with Crohn's disease who are responding to EEN induction therapy.
FUNDING: Assistance Publique-Hôpitaux de Paris and Nestlé Health Science.