Crohn Disease
Conditions
Keywords
Exclusive Enteral Nutrition, Nutrition, Diet, Inflammatory Bowel Disease
Brief summary
Primary: Nutritional therapy in the form of a whole-food based smoothie can be used to induce remission of active Crohn's disease. Secondary: Consuming a whole foods based smoothie will result in measurable changes to the microbiome of individuals with Crohn's disease and healthy controls. The specific aims of this proposal are: 1. To develop a whole-food based smoothie, based on principles of the specific carbohydrate diet, that is comparable in macronutrients and micronutrients to formulas used for exclusive enteral nutritional (EEN) therapy in Crohn's disease. 2. To evaluate the ability of a whole-food based smoothie to induce remission of active Crohn's disease. 3. To evaluate changes to the intestinal microbiome in healthy individuals consuming a whole-food based smoothie diet.
Detailed description
This will be an open label, pilot study over 4 weeks in children with newly diagnosed Crohn's disease treated with a smoothie designed to emulate formulas used for exclusive enteral nutritional therapy. In place of formula, whole-foods based smoothie recipes and the food to create the smoothies will be given to each participant/family. The smoothies will be based upon the concept of reverse-engineering of exclusive enteral nutrition (RE-EEN). The smoothie recipes will involve whole foods that can be blenderized to liquid consistency. Similar to the formulas used for EEN, the smoothies will provide calories, protein, fat, and carbohydrates in a distribution to support growth and development.
Interventions
OTHERNutritional therapy
Whole-foods based smoothie designed to emulate formulas used in EEN
Sponsors
Dale Lee
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
1. Age 8 -21 years old 2. Diagnosis of Crohn's disease within 4 weeks of study entry 3. Active Crohn's disease, as defined by Pediatric Crohn's Disease Activity Index (PCDAI) ≥10. 4. Participant capable of giving informed consent, or if a minor the parent/guardian is capable of giving informed consent
Exclusion criteria
1. History of surgery for Crohn's disease 2. Perianal disease as part of Crohn's disease phenotype 3. Prior treatment with EEN or the specific carbohydrate for Crohn's disease 4. Prior treatment with any immunosuppressive medication (corticosteroids, anti-TNF-alpha agent, azathioprine, methotrexate, etc.) 5. Prior treatment with antibiotics for Crohn's disease 6. Known allergies to any of the food components in the smoothie 7. Admission to hospital due to severity of Crohn's disease and associated symptoms 8. Unwillingness to provide informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fecal calprotectin <250 micrograms/gram | 4 weeks | surrogate marker of intestinal inflammation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life as measured by IMPACT III Questionnaire | 4 weeks | validated quality of life measure for pediatric inflammatory bowel disease |
Countries
United States
Outcome results
None listed