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

NCT06216899 | Recruiting

• 1 other identifier: STUDY00004459
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 3

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

Keywords

Crohn's; Inflammatory Bowel Disease; CD

Outcome Measures

Primary Outcomes (1)

• Tolerance- Ability to remain on prescribed nutritional therapy

  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.

  4 and 8 weeks

Secondary Outcomes (2)

• Fecal Calprotectin reduction from baseline

  4 and 8 weeks

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

  4 and 8 weeks

Study Arms (2)

Smoothie

EXPERIMENTAL

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

Other: Whole-food based smoothie

Formula

ACTIVE COMPARATOR

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

Other: Formula

Interventions

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.

Smoothie

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.

Formula

Eligibility Criteria

• Age: 8 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Seattle Children's Hospital: lead
• Children's Hospital of Philadelphia: collaborator
• Dalhousie University: collaborator

Study Sites (3)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19146, United States

NOT YET RECRUITING

Seattle Children's Hospital

Seattle, Washington, 98105, United States

RECRUITING

Izaak Walton Killam Health Centre

Halifax, Nova Scotia, B3J 0C3, Canada

NOT YET RECRUITING

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases

Interventions

Food, Formulated

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Foods, Specialized; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Dale Lee, MD, MSCE

  Seattle Children's Hospital, University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mason E Nuding

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Medical Director, Clinical Nutrition; Director of the Celiac Disease Program

Study Record Dates

• First Submitted: January 4, 2024
• First Posted: January 22, 2024
• Study Start: March 11, 2024
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): January 10, 2030
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (2)