Reverse Engineering of Exclusive Enteral Nutrition

Crohn Disease Clinical Trial

— RE-EEN  

Official title:

Reverse-Engineering of Exclusive Enteral Nutrition (RE-EEN) in Crohn's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03508193
• Other study ID #: STUDY00000619
• Status: Completed
• Phase: N/A
• Start date: November 4, 2017
• Est. completion date: January 5, 2022

Study information

• Verified date: November 2022
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 5, 2022
• Est. primary completion date: January 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Other:
• Nutritional therapy
Whole-foods based smoothie designed to emulate formulas used in EEN

Locations

Country	Name	City	State
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Dale Lee

Country where clinical trial is conducted

United States, 

References & Publications (2)

Johnson T, Macdonald S, Hill SM, Thomas A, Murphy MS. Treatment of active Crohn's disease in children using partial enteral nutrition with liquid formula: a randomised controlled trial. Gut. 2006 Mar;55(3):356-61. Epub 2005 Sep 14. — View Citation

Lee D, Baldassano RN, Otley AR, Albenberg L, Griffiths AM, Compher C, Chen EZ, Li H, Gilroy E, Nessel L, Grant A, Chehoud C, Bushman FD, Wu GD, Lewis JD. Comparative Effectiveness of Nutritional and Biological Therapy in North American Children with Active Crohn's Disease. Inflamm Bowel Dis. 2015 Aug;21(8):1786-93. doi: 10.1097/MIB.0000000000000426. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fecal calprotectin <250 micrograms/gram	surrogate marker of intestinal inflammation	4 weeks
Secondary	Quality of life as measured by IMPACT III Questionnaire	validated quality of life measure for pediatric inflammatory bowel disease	4 weeks