Recruiting

Exclusive Enteral Nutrition

Sponsor:

Seattle Children's Hospital

Code:

NCT06216899

Conditions

Crohn Disease

Eligibility Criteria

Sex: All

Age: 8 - 21

Healthy Volunteers: Not accepted

Interventions

Whole-food based smoothie

Formula

Study Details

Brief summary:

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.

Conditions

Crohn Disease

Study ID

NCT06216899

Start date

Mar 11, 2024

Status verified date

Jun, 2025

Completion date

Jan 10, 2030

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 21

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Smoothie

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

active comparator: Formula

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

Interventions

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.

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.

Primary outcome measure

  • Tolerance- Ability to remain on prescribed nutritional therapy [ Time Frame: 4 and 8 weeks ]

Central Contacts and Locations

Central contacts

Mason E Nuding

206-987-0055mason.nuding@seattlechildrens.org

Locations

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Danny Gagucas

206-987-1062Danny.Gagucas@seattlechildrens.org

Principal Investigator:

Dale Lee, MD, MSCE

More Information

Sponsor

Seattle Children's Hospital

Last update posted

Jun 12, 2025

Last verified

Jun, 2025

Keywords

  • Crohn's
  • Inflammatory Bowel Disease
  • CD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Seattle Children's Hospital on 2025-06-12.