Reverse-Engineering of Exclusive Enteral Nutrition (RE-EEN) in Crohn's Disease: A Multi-Center Trial

Crohn Disease Clinical Trial

— mRE-EEN  

Official title:

Reverse-Engineering of Exclusive Enteral Nutrition (RE-EEN) in Crohn's Disease: A Multi-Center Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06216899
• Other study ID #: STUDY00004459
• Status: Recruiting
• Phase: N/A
• Start date: March 11, 2024
• Est. completion date: January 10, 2027

Study information

• Verified date: May 2024
• Source: Seattle Children's Hospital
• Contact: Mason E Nuding
• Phone: 206-987-0055
• Email: mason.nuding[@]seattlechildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 10, 2027
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Other:
• Whole-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.
• Formula
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.

Locations

Country	Name	City	State
Canada	Izaak Walton Killam Health Centre	Halifax	Nova Scotia
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Seattle Children's Hospital	Children's Hospital of Philadelphia, Dalhousie University

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerance- Ability to remain on prescribed nutritional therapy	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.	4 and 8 weeks
Secondary	Fecal Calprotectin reduction from baseline	Fecal calprotectin (FCP) level <250 µg/gram	4 and 8 weeks
Secondary	Pediatric Crohn's Disease Activity Index (PCDAI) reduction from baseline	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)	4 and 8 weeks