Crohn Disease
Conditions
Keywords
Crohn's, Inflammatory Bowel Disease, CD
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.
Interventions
OTHERWhole-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.
OTHERFormula
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.
Sponsors
Children's Hospital of Philadelphia
Dalhousie University
Seattle Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 21 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Canada, United States
Contacts
Primary ContactMason E Nuding
Outcome results
None listed