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

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.

Study Overview

• Status: Recruiting
• Conditions: Crohn Disease
• Intervention / Treatment: Other: Whole-food based smoothie; Other: Formula

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mason E Nuding; Phone Number: 206-987-0055; Email: mason.nuding@seattlechildrens.org

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3J 0C3
      • Not yet recruiting
      • Izaak Walton Killam Health Centre
      • Contact: Bradley MacIntyre MacIntyre; Phone Number: 902-470-7009; Email: Brad.MacIntyre@iwk.nshealth.ca
      • Principal Investigator: Anthony Otley, MD, MSc
• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19146
      • Not yet recruiting
      • Children's Hospital of Philadelphia
      • Principal Investigator: Lindsey Albenberg, DO
      • Contact: Clarice Cook; Phone Number: 445-942-7445; Email: cookc4@chop.edu
  • Washington
    • Seattle, Washington, United States, 98105
      • Recruiting
      • Seattle Children's Hospital
      • Sub-Investigator: David Suskind, MD
      • Contact: Danny Gagucas; Phone Number: 206-987-1062; Email: Danny.Gagucas@seattlechildrens.org
      • Principal Investigator: Dale Lee, MD, MSCE
      • Sub-Investigator: Betty Zheng, MD
      • Sub-Investigator: Ghassan Wahbeh, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smoothie; 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; 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.
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fecal Calprotectin reduction from baseline	Fecal calprotectin (FCP) level <250 μg/gram	4 and 8 weeks
Pediatric Crohn's Disease Activity Index (PCDAI) reduction from baseline	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)	4 and 8 weeks

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital
• Collaborators: Children's Hospital of Philadelphia; Dalhousie University
• Investigators: Principal Investigator: Dale Lee, MD, MSCE, Seattle Children's Hospital, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): January 10, 2027

Study Registration Dates

• First Submitted: January 4, 2024
• First Submitted That Met QC Criteria: January 17, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Estimated): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Inflammatory Bowel Disease; CD; Crohn's
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: STUDY00004459

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No