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

Seattle Children's Healthcare System

Status: Enrolling

Conditions: Crohn Disease

Treatments: Other: Formula; Other: Whole-food based smoothie

Study type: Interventional

Funder types: Other

Identifiers

NCT06216899

STUDY00004459

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 8 to 21 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Smoothie

Experimental group

Description:

In the smoothie arm, you will be provided instructions, a blender, and food components to prepare the smoothie at home.

Treatment:

Other: Whole-food based smoothie

Formula

Active Comparator group

Description:

In the formula arm, you will be given conventional formula as per the direction of the gastroenterology team along with our dieticians.

Treatment:

Other: Formula