RECRUITING

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

Conditions

Crohn Disease Crohn's Inflammatory Bowel Disease CD

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-03-11

Study Completion:2027-01-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06216899

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:8 Years to 21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Mason E Nuding

CONTACT

206-987-0055

mason.nuding@seattlechildrens.org

Principal Investigator

Dale Lee, MD, MSCE

PRINCIPAL_INVESTIGATOR

Seattle Children's Hospital, University of Washington

Study Locations (Sites)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19146

United States

Seattle Children's Hospital

Seattle, Washington, 98105

United States

Collaborators and Investigators

Sponsor: Seattle Children's Hospital

Dale Lee, MD, MSCE, PRINCIPAL_INVESTIGATOR, Seattle Children's Hospital, University of Washington

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-11

Study Completion Date2027-01-10

Study Record Updates

Study Start Date2024-03-11

Study Completion Date2027-01-10

Terms related to this study

Keywords Provided by Researchers

Crohn's
Inflammatory Bowel Disease
CD

Additional Relevant MeSH Terms

Crohn Disease