Clinical trial NCT06216899: Reverse-Engineering of Exclusive Enteral Nutrition (RE-EEN) in Crohn's Disease: A Multi-Center Trial
Official title: Reverse-Engineering of Exclusive Enteral Nutrition (RE-EEN) in Crohn's Disease: A Multi-Center Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Crohn Disease
Keywords: Crohn's
Inflammatory Bowel Disease
CD
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Philadelphia
name: Dalhousie University
First posted: 2024-01-22
Enrollment: 60
Sex: ALL
Minimum age (years): 8
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Tolerance- Ability to remain on prescribed nutritional therapy
timeFrame: 4 and 8 weeks
Secondary outcomes:
measure: Fecal Calprotectin reduction from baseline
timeFrame: 4 and 8 weeks
measure: Pediatric Crohn's Disease Activity Index (PCDAI) reduction from baseline
timeFrame: 4 and 8 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Halifax
country: Canada
facility: Izaak Walton Killam Health Centre
state: Nova Scotia
Study officials:
affiliation: Seattle Children's Hospital, University of Washington
name: Dale Lee, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: