Liquid Diets for Crohn's Disease
(mRE-EEN Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop all current medications, but you cannot have recently used corticosteroids, adjusted immunomodulators, or started certain medications like azathioprine or methotrexate close to the study's end. It's best to discuss your current medications with the study team.
What data supports the effectiveness of the treatment for Crohn's disease?
Research shows that liquid diets, like defined formula diets, can be effective in reducing inflammation and improving growth in children with Crohn's disease. These diets have been found to be as effective as corticosteroids in managing symptoms and may help maintain remission, especially in pediatric patients.12345
Is a liquid diet safe for people with Crohn's disease?
How is the liquid diet treatment for Crohn's disease different from other treatments?
What is the purpose of this trial?
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.
Research Team
Dale Lee, MD, MSCE
Principal Investigator
Seattle Children's Hospital, University of Washington
Eligibility Criteria
This trial is for children and young adults aged 8-21 who have been diagnosed with Crohn's disease within the last two years. They must show active symptoms, as indicated by a specific activity index score (PCDAI ≥10) and elevated inflammation markers. Participants or their guardians must be able to give informed consent.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either conventional formula or whole-food blended smoothie EEN for 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Formula
- Whole-food based smoothie
Formula is already approved in European Union, United States, Canada for the following indications:
- Nutritional support for infants
- Nutritional support for infants
- Supplementation for breastfeeding
- Nutritional support for infants
- Supplementation for breastfeeding in well-baby units
Find a Clinic Near You
Who Is Running the Clinical Trial?
Seattle Children's Hospital
Lead Sponsor
Children's Hospital of Philadelphia
Collaborator
Dalhousie University
Collaborator