Reverse-Engineering of Exclusive Enteral Nutrition (RE-EEN) in Crohn's Disease: A Multi-Center Trial
- Conditions
- Crohn Disease
- Interventions
- Other: Whole-food based smoothieOther: Formula
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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
- Arm && Interventions
Group Intervention Description Smoothie Whole-food based smoothie In the smoothie arm, you will be provided instructions, a blender, and food components to prepare the smoothie at home. Formula Formula In the formula arm, you will be given conventional formula as per the direction of the gastroenterology team along with our dieticians.
- 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)
Izaak Walton Killam Health Centre
🇨🇦Halifax, Nova Scotia, Canada
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States