Liquid Diets for Crohn's Disease
(mRE-EEN Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness of two different liquid diets for children recently diagnosed with Crohn's disease. One group will consume a regular formula, similar to infant or baby formula, while the other will prepare and drink a special smoothie using provided ingredients and a blender. Researchers aim to determine which diet is easier to adhere to and more effective at improving symptoms, gut health, and overall quality of life over 8 weeks. Suitable candidates for the trial are children diagnosed with Crohn's disease within the last two years who continue to experience symptoms. As an unphased trial, this study offers a unique opportunity to enhance understanding of dietary impacts on Crohn's disease in children.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that both the whole-food blended smoothie and the commercial formula used in Exclusive Enteral Nutrition (EEN) for Crohn's disease are well-tolerated by patients. Studies have found that the whole-food smoothie is as effective and safe as the commercial formulas typically used in EEN. Patients experienced similar improvements in symptoms and reductions in FCP, a marker for inflammation, as those using commercial formulas.
This indicates that both treatment options in the study are generally safe for children newly diagnosed with Crohn's disease. Studies involving these treatments reported no major side effects, which is reassuring for those considering participation in this clinical trial.12345Why are researchers excited about this trial?
Researchers are excited about these treatments because they offer a new approach to managing Crohn's Disease through diet. Unlike traditional treatments that often rely on medications like corticosteroids or immunosuppressants, these dietary interventions use nutrition to potentially ease symptoms. The smoothie arm is unique as it involves a whole-food based approach, allowing patients to prepare and consume a nutrient-rich smoothie at home, which may be more palatable and engaging for some individuals. Meanwhile, the formula arm provides a conventional nutritional formula under expert guidance, aiming to simplify dietary management. Both options explore how dietary changes can impact Crohn's Disease, offering a potentially less invasive and more natural management strategy.
What evidence suggests that this trial's treatments could be effective for Crohn's disease?
Research has shown that using whole-food blended smoothies as the sole source of nutrition can be very effective for children with Crohn's disease. One study found that 80% of children who tried this smoothie method experienced significant symptom improvement, achieving remission. In this trial, participants in the smoothie arm will prepare these smoothies at home, offering a natural and potentially more enjoyable way to manage Crohn's symptoms. Participants in the formula arm will receive conventional formula, which previous studies have shown to be as effective as the smoothie method. Early research also suggests that whole foods might benefit gut health. This method could offer a refreshing alternative to standard formulas, which some find less appealing.12367
Who Is on the Research Team?
Dale Lee, MD, MSCE
Principal Investigator
Seattle Children's Hospital, University of Washington
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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