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

Not Applicable

Recruiting

• Conditions: Crohn Disease

• Registration Number: NCT06216899
• Lead Sponsor: Seattle Children's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-04
• Study First Submitted QC: 2024-01-17
• Study First Posted: 2024-01-22
• Study Start: 2024-03-11
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-09
• Last Update Posted: 2025-06-12
• Primary Completion: 2027-04-01
• Study Completion: 2030-01-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Tolerance- Ability to remain on prescribed nutritional therapy	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 Outcome Measures

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

Trial Locations

Locations (3)

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Seattle Children's Hospital; 🇺🇸 Seattle, Washington, United States

Izaak Walton Killam Health Centre; 🇨🇦 Halifax, Nova Scotia, Canada