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RECRUITINGINTERVENTIONAL

Reverse-Engineering of Exclusive Enteral Nutrition (RE-EEN) in Crohn's Disease: A Multi-Center Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This study will compare the tolerability and efficacy of conventional formula Exclusive Enteral Nutrition (EEN) and whole-food blended smoothie EEN by enrolling a total of 60 participants with newly diagnosed pediatric Crohn's disease (CD). Participants will be provided either commercial formula or guided on the preparation of the home-blended smoothie. These participants will be given a specific recipe, blender, and be provided the food components to the smoothie. The study will total 8 weeks and will assess tolerance, clinical outcomes, stool microbiome, and quality of life.

Who May Be Eligible (Plain English)

Who May Qualify: - Age 8 -21 years old. - Diagnosis of Crohn's disease within 24 months - Elevation in objective inflammatory markers at enrollment: C-reactive protein (CRP), ESR, or fecal calprotectin - Active Crohn's disease, as defined by Pediatric Crohn's Disease Activity Index (PCDAI) ≥10. - Participant capable of giving willing to sign a consent form, or if a minor the parent/guardian is capable of giving willing to sign a consent form. Who Should NOT Join This Trial: - History of surgery for Crohn's disease. - Perianal disease as part of Crohn's disease phenotype. - Recent use of: - corticosteroids (within 4 weeks), - dose adjustment of immunomodulator (within 8 week) - azathioprine 4 weeks prior to study final visit (week 8) - start or adjust methotrexate 3 weeks prior to final study visit. - Prior use of biological medication - Prior treatment with EEN or other dietary therapy for Crohn's disease. - Prior treatment with antibiotics for Crohn's disease. - Known allergies to any of the food components in the smoothie. - Admission to hospital due to severity of Crohn's disease and associated symptoms. - Unwillingness to provide willing to sign a consent form. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Age 8 -21 years old. * Diagnosis of Crohn's disease within 24 months * Elevation in objective inflammatory markers at enrollment: C-reactive protein (CRP), ESR, or fecal calprotectin * Active Crohn's disease, as defined by Pediatric Crohn's Disease Activity Index (PCDAI) ≥10. * Participant capable of giving informed consent, or if a minor the parent/guardian is capable of giving informed consent. Exclusion Criteria: * History of surgery for Crohn's disease. * Perianal disease as part of Crohn's disease phenotype. * Recent use of: * corticosteroids (within 4 weeks), * dose adjustment of immunomodulator (within 8 week) * azathioprine 4 weeks prior to study final visit (week 8) * start or adjust methotrexate 3 weeks prior to final study visit. * Prior use of biological medication * Prior treatment with EEN or other dietary therapy for Crohn's disease. * Prior treatment with antibiotics for Crohn's disease. * Known allergies to any of the food components in the smoothie. * Admission to hospital due to severity of Crohn's disease and associated symptoms. * Unwillingness to provide informed consent.

Treatments Being Tested

OTHER

Whole-food based smoothie

The smoothies will be based upon the concept of reverse-engineering of exclusive enteral nutrition and provide 100% of calculated caloric needs for weeks 0-4. At week 4, select foods will be introduced to provide up to 20% of daily caloric needs.

OTHER

Formula

Conventional formula (Boost, Ensure, Modulen) as per the direction of their primary Gastroenterology team to provide 100% of calculated caloric needs for weeks 0-4. At week 4, select foods will be introduced to provide up to 20% of daily caloric needs.

Locations (3)

Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Seattle Children's Hospital
Seattle, Washington, United States
Izaak Walton Killam Health Centre
Halifax, Nova Scotia, Canada