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NCT Number: NCT06216899

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

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Key information

Conditions

Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

8 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Izaak Walton Killam Health Centre, Halifax, Nova Scotia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Whole-food based smoothie

Other

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.

Formula

Other

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.

Primary outcomes

  1. Tolerance- Ability to remain on prescribed nutritional therapy

    Time frame: 4 and 8 weeks

    Tolerance of therapy as measured by ability to continue prescribed nutritional therapy over 4-weeks and 8-weeks without deviation from protocol. Participants will meet with a study dietitian at week 2, week4, and week 8. Dietitians will evaluate caloric needs, specific deficits, and dietary limitations.

Secondary outcomes

  1. Fecal Calprotectin reduction from baseline

    Time frame: 4 and 8 weeks

    Fecal calprotectin (FCP) level <250 μg/gram

  2. Pediatric Crohn's Disease Activity Index (PCDAI) reduction from baseline

    Time frame: 4 and 8 weeks

    Pediatric Crohn's Disease Activity Index (PCDAI) score <10 (clinical remission).

    PCDAI will be calculated at each visit. The total score is calculated from assessments in 11 sections. Minimum score 0. Maximum score 100. A lower score is better.

    History (recall 1 week)

    • Abdominal pain
    • Stools
    • Patient functioning
    • General well-being

    Physical Examination

    • Weight
    • Height
    • Abdomen
    • Peri-rectal disease
    • Extra-intestinal manifestations

    Laboratory

    • Hematocrit (%)
    • Erythrocyte sedimentation rate (ESR) (mm/hr)
    • Albumin (g/L)

Study contacts

Contact information is provided by the study sponsor or research team.

Mason E Nuding

CONTACT

[email protected]

206-987-0055

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Collaborators

  • Children's Hospital of Philadelphia
  • Dalhousie University

Registry information

Acronym: mRE-EEN

Important dates

Study start
2024
Primary completion
2027
Study completion
2030
First posted
Jan 22, 2024
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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