None listed
Conditions
Brief summary
This study will evaluate a reverse-engineered exclusive enteral nutrition (RE-EEN) whole-food smoothie intervention compared with standard exclusive enteral nutrition (EEN) formula for the induction of remission in children with Crohn’s disease. Participants will be randomised to receive either commercially available enteral formula or a nutritionally complete whole-food smoothie diet designed to replicate the therapeutic properties of EEN. The intervention will provide 100% of energy requirements for the first 4 weeks, followed by the gradual introduction of limited whole foods while maintaining nutritional therapy until week 8. Clinical outcomes, inflammatory biomarkers, dietary adherence, and quality of life will be assessed throughout the study. The aim is to determine whether a whole-food–based nutritional therapy can achieve comparable clinical remission and biological responses to standard EEN while potentially improving tolerability and acceptability.
Interventions
Participants will be randomised to one of two dietary treatment arms for the induction of remission in Crohn’s disease over an 8-week period.
Intervention arm – Reverse-Engineered Exclusive Enteral Nutrition (RE-EEN):
Participants will consume a whole-food–based smoothie diet designed to replicate the nutritional composition and therapeutic properties of EEN. Smoothies will be prepared using whole food ingredients blended to liquid consistency and supplemented with a daily multivitamin to ensur
Participants will be randomised to one of two dietary treatment arms for the induction of remission in Crohn’s disease over an 8-week period. Intervention arm – Reverse-Engineered Exclusive Enteral Nutrition (RE-EEN): Participants will consume a whole-food–based smoothie diet designed to replicate the nutritional composition and therapeutic properties of EEN. Smoothies will be prepared using whole food ingredients blended to liquid consistency and supplemented with a daily multivitamin to ensure nutritional adequacy. The smoothie diet will provide 100% of daily energy requirements from baseline to week 4. From week 4 to week 8, selected whole foods will be introduced to provide up to 20% of daily energy intake, mirroring the protocol used in the control arm. Participants will receive dietary counselling from a registered dietitian at baseline and at weeks 2, 4, and 8 to monitor adherence, ensure nutritional adequacy, and adjust energy prescriptions as required. the number/frequency of smoothie consumption each day will be based on their nutritional requirements using the Schofield calculation for pediatric growth. For example, a 9 year old male may require 1800ml at 1ckal/kg of body weight (approximately 7 x 250ml daily). - the mode of dietary counselling will be a combination of face-to-face and telehealth appointments. - the approximate duration of dietary counselling will be 30 minutes.
Sponsors
Seattle Children's Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
6 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
Participants must meet the following criteria to be eligible for enrolment: Children or adolescents diagnosed with Crohn’s disease, confirmed by standard clinical, endoscopic, radiologic, and histologic criteria. Active disease requiring induction therapy, as determined by the treating gastroenterology team. Eligible for dietary induction therapy using exclusive enteral nutrition (EEN) as part of their clinical management. Able to consume oral nutritional therapy, including formula or blended smoothie-based nutrition, or willing to receive nutrition via nasogastric tube if required. Able to provide informed consent/assent, with parent or legally authorised representative consent for participants under 18 years of age. Willing to adhere to study procedures, including dietary intervention, clinical visits, laboratory testing, and questionnaires during the 8-week study period. These criteria ensure enrolment of participants with active Crohn’s disease appropriate for induction with nutritional therapy and who are able to safely participate in the dietary intervention.
Exclusion criteria
Participants will be excluded if they meet any of the following criteria: Diagnosis of ulcerative colitis, IBD-unclassified, or another gastrointestinal disorder rather than Crohn’s disease. Severe Crohn’s disease requiring immediate corticosteroid therapy, biologic therapy, or hospitalisation, where exclusive nutritional therapy would not be appropriate as initial management. Known food allergies or intolerances to key components of the smoothie intervention that would make participation unsafe. Medical conditions that impair the ability to safely consume or tolerate enteral nutrition, including significant swallowing disorders or severe gastrointestinal obstruction. Current use of corticosteroids, biologic therapy, or other induction therapies for Crohn’s disease at the time of enrolment that would confound study outcomes. Inability or unwillingness to adhere to the dietary intervention or study procedures, including scheduled visits, dietary requirements, or laboratory testing. Participation in another interventional clinical trial that could interfere with the outcomes of this study.
Outcome results
None listed