Crohn Disease
Whole-Food Smoothie vs Formula Nutrition for Young People With Crohn’s Disease
This randomized study compares the tolerability and clinical outcomes of whole-food blended smoothie nutrition and conventional formula nutrition over eight weeks in people ages 8 to 21 with recently diagnosed, active Crohn’s disease.
Registry title: Reverse-Engineering of Exclusive Enteral Nutrition (RE-EEN) in Crohn's Disease: A Multi-Center Trial
2 recruiting U.S. sites ↓Study at a glance
- Age
- 8 Years–21 Years
- Treatment
- Whole-food based smoothie or Formula
- Design
- Randomized
- Central study contact
- Mason E Nuding206-987-0055mason.nuding@seattlechildrens.org
- Sponsor
- Seattle Children's Hospital
Research question
How do whole-food blended smoothie nutrition and conventional formula nutrition compare in tolerability, clinical outcomes, stool microbiome, and quality of life among young people with recently diagnosed Crohn’s disease?
Participant snapshot
Who the study is looking for
- The study is looking for people ages 8 to 21.
- The study is looking for people diagnosed with Crohn’s disease within the past 24 months.
- The study is looking for people with active Crohn’s disease, defined as a Pediatric Crohn’s Disease Activity Index score of at least 10.
- The study is looking for people with an elevated C-reactive protein, erythrocyte sedimentation rate, or fecal calprotectin result at enrollment.
- Study locations are listed in Seattle, Philadelphia, and Halifax, but only the Seattle site was listed as recruiting when the registry status was verified.
Participation overview
What participation may involve
Participation lasts eight weeks. Participants follow either the whole-food smoothie plan or conventional formula plan, initially meeting all calculated calorie needs with the assigned nutrition and adding selected foods beginning at week 4. What participation may involve: - Follow the assigned smoothie or formula nutrition plan, providing 100% of calculated calorie needs during weeks 0 through 4. - Introduce selected foods at week 4 to provide up to 20% of daily calorie needs. - Meet with a study dietitian at weeks 2, 4, and 8 to review calorie needs, nutritional deficits, and dietary limitations. - Complete assessments of treatment tolerance, Crohn’s disease activity, fecal calprotectin, stool microbiome, and quality of life. The registry states that the study lasts eight weeks. The registry explicitly reports dietitian meetings at weeks 2, 4, and 8, but does not provide a complete schedule of every study visit or activity.
Study interventions
What participants may receive or do
- Whole-food based smoothie: Participants assigned to this group prepare a specified smoothie at home using provided instructions, a blender, and food components. The smoothie supplies all calculated calorie needs during weeks 0 through 4; selected foods are then introduced to supply up to 20% of daily calorie needs.
- Formula: Participants assigned to this group receive conventional formula, such as Boost, Ensure, or Modulen, under guidance from their gastroenterology team and study dietitians. Formula supplies all calculated calorie needs during weeks 0 through 4; selected foods are then introduced to supply up to 20% of daily calorie needs.
Study design
How the comparison works
This is an open-label, randomized, parallel-group study comparing a whole-food smoothie approach with conventional formula nutrition in an estimated 60 participants. Participants are randomly assigned to the smoothie group or the formula group. The study uses no masking, so participants and the study team know which nutrition approach is assigned. Conventional formula nutrition is the active comparison group. The registry does not list a placebo or sham group; both groups receive a nutritional intervention.
Reported activities
Procedures and tests
- Dietitian assessments at weeks 2, 4, and 8 review calorie needs, nutritional deficits, and dietary limitations.
- Fecal calprotectin is measured to assess change from baseline at weeks 4 and 8.
- The Pediatric Crohn’s Disease Activity Index is calculated at each visit using symptoms, functioning, general well-being, physical examination findings, and laboratory results.
- The disease-activity assessment includes abdominal pain, stools, weight, height, abdominal and perirectal findings, extraintestinal manifestations, hematocrit, erythrocyte sedimentation rate, and albumin.
- The study assesses the stool microbiome and quality of life, although the registry does not describe the collection or questionnaire methods.
- Screening may involve confirming elevated C-reactive protein, erythrocyte sedimentation rate, or fecal calprotectin and a Pediatric Crohn’s Disease Activity Index score of at least 10.
Eligibility highlights
Details that may affect whether you contact the study
These are selected highlights, not a complete eligibility check. Exact criteria remain in the full registry record below.
Common requirements
- Participants must be 8 through 21 years old.
- Crohn’s disease must have been diagnosed within the previous 24 months.
- At enrollment, at least one objective inflammation marker—C-reactive protein, erythrocyte sedimentation rate, or fecal calprotectin—must be elevated.
- Crohn’s disease must be active, defined by a Pediatric Crohn’s Disease Activity Index score of at least 10.
- The participant must be able to provide informed consent, or a parent or guardian must be able to consent for a minor.
Possible reasons someone may not be able to join
- People with a history of surgery for Crohn’s disease are excluded.
- People whose Crohn’s disease includes perianal disease are excluded.
- Corticosteroid use within the previous four weeks is excluded.
- An immunomodulator dose adjustment within the previous eight weeks is excluded.
- The registry lists restrictions involving azathioprine during the four weeks before the final week-8 visit and starting or adjusting methotrexate during the three weeks before that visit; the exact intended timing should be confirmed with the study team.
- Any previous use of a biologic medication is excluded.
- Previous exclusive enteral nutrition or another dietary therapy for Crohn’s disease is excluded.
- Previous antibiotic treatment for Crohn’s disease is excluded.
- A known allergy to any food component in the smoothie is excluded.
- People admitted to a hospital because of the severity of Crohn’s disease and related symptoms are excluded.
Important unknowns
What the record does not make clear
- Dietitian meetings at weeks 2, 4, and 8 are reported, but the complete schedule, visit locations, and time required for all assessments are not provided.
- The registry lists restrictions on several current or previous Crohn’s treatments but does not clearly state which ongoing medications may remain unchanged during the study.
- Some medication timing windows are listed, but the azathioprine and methotrexate wording is difficult to interpret and no complete washout plan is provided.
- The registry does not state what treatment is available if Crohn’s disease worsens or the assigned nutrition cannot be continued.
- The registry does not state whether endoscopy or other imaging is required for screening or follow-up.
- The registry says smoothie supplies and a blender are provided and formula is given, but it does not explain other study-related costs, routine-care charges, or insurance billing.
- The registry does not report whether participants receive compensation.
- The registry does not report whether transportation, lodging, parking, or meal expenses are reimbursed.
- The registry does not state whether any visits or dietitian meetings can occur remotely.
- The overall study is recruiting, Seattle is listed as recruiting, and the Philadelphia and Halifax sites are listed as not yet recruiting; current openings still require confirmation.
Before contacting the site
Questions for the study team
- What is the complete schedule of in-person and remote visits, tests, stool collections, and questionnaires?
- Which current Crohn’s disease medications can continue, and would any medication need to be stopped or kept at a stable dose?
- What treatment or medical support is available if symptoms worsen or the assigned nutrition cannot be tolerated?
- Are endoscopy, imaging, blood draws, or additional stool samples required beyond the assessments described in the registry?
- How are calorie needs calculated, and how are food allergies, dietary limitations, and nutritional deficits handled in each group?
- Which study-related costs are covered, and are compensation or travel reimbursements available?
- Which listed sites are currently enrolling, and can participants enroll at a site other than Seattle?
Before changing care
Questions for your gastroenterologist
- Would following either nutrition plan affect the stability of my current Crohn’s disease or nutritional status?
- How might the study’s medication restrictions affect my current treatment, and should any changes be discussed with the research team?
- What approved treatment alternatives should I understand while considering whether to contact this study?
- What signs of worsening disease or nutritional problems would require prompt clinical care during an eight-week nutrition plan?
- How should my gastroenterology team and the research dietitian coordinate disease monitoring, laboratory results, and medication decisions?
This plain-language digest is provided by the Aidy clinical trials API. It may omit details and is not medical advice or an eligibility decision. Review the full registry record and confirm details with the study team.
Source record
Full registry record
The sections below preserve the study information supplied through ClinicalTrials.gov, including complete descriptions, criteria, outcomes, and locations.
About this study
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.
Study design and administration
- Organization
- Seattle Children's Hospital
- Organization class
- Other
- Organization study ID
- STUDY00004459
- Lead sponsor
- Seattle Children's Hospital
- Sponsor class
- Other
- Enrollment type
- Estimated
- Allocation
- Randomized
- Intervention model
- Parallel
- Primary purpose
- Treatment
- Masking
- None
- Who is masked
- Not provided
- Standard age groups
- Child, Adult
Study arms
Experimental
Smoothie
In the smoothie arm, you will be provided instructions, a blender, and food components to prepare the smoothie at home.
Interventions: Other: Whole-food based smoothie
Active Comparator
Formula
In the formula arm, you will be given conventional formula as per the direction of the gastroenterology team along with our dieticians.
Interventions: Other: Formula
Interventions
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.
Other
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.
Eligibility
8 Years–21 Years
All
Not accepted
Inclusion criteria (5)
- Age 8 -21 years old.Registry-derived · unreviewed
- Diagnosis of Crohn's disease within 24 monthsRegistry-derived · unreviewed
- Elevation in objective inflammatory markers at enrollment: C-reactive protein (CRP), ESR, or fecal calprotectinRegistry-derived · unreviewed
- Active Crohn's disease, as defined by Pediatric Crohn's Disease Activity Index (PCDAI) ≥10.Registry-derived · unreviewed
- Participant capable of giving informed consent, or if a minor the parent/guardian is capable of giving informed consent.Registry-derived · unreviewed
Exclusion criteria (13)
- History of surgery for Crohn's disease.Registry-derived · unreviewed
- Perianal disease as part of Crohn's disease phenotype.Registry-derived · unreviewed
- Recent use of:Registry-derived · unreviewed
- corticosteroids (within 4 weeks),Registry-derived · unreviewed
- dose adjustment of immunomodulator (within 8 week)Registry-derived · unreviewed
- azathioprine 4 weeks prior to study final visit (week 8)Registry-derived · unreviewed
- start or adjust methotrexate 3 weeks prior to final study visit.Registry-derived · unreviewed
- Prior use of biological medicationRegistry-derived · unreviewed
- Prior treatment with EEN or other dietary therapy for Crohn's disease.Registry-derived · unreviewed
- Prior treatment with antibiotics for Crohn's disease.Registry-derived · unreviewed
- Known allergies to any of the food components in the smoothie.Registry-derived · unreviewed
- Admission to hospital due to severity of Crohn's disease and associated symptoms.Registry-derived · unreviewed
- Unwillingness to provide informed consent.Registry-derived · unreviewed
This information can identify a possible match, conflict, or item needing confirmation. Only the study team can determine eligibility.
Study outcomes
Primary outcome
Tolerance- Ability to remain on prescribed nutritional therapy
Time frame: 4 and 8 weeks
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.
Secondary outcome
Fecal Calprotectin reduction from baseline
Time frame: 4 and 8 weeks
Fecal calprotectin (FCP) level \<250 μg/gram
Secondary outcome
Pediatric Crohn's Disease Activity Index (PCDAI) reduction from baseline
Time frame: 4 and 8 weeks
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)
Recruiting locations in the United States
Children's Hospital of Philadelphia
Not Yet RecruitingPhiladelphia, Pennsylvania, 19146, United States
Clarice Cook445-942-7445cookc4@chop.edu
Lindsey Albenberg, DO
Seattle Children's Hospital
RecruitingSeattle, Washington, 98105, United States
Danny Gagucas206-987-1062Danny.Gagucas@seattlechildrens.org
Dale Lee, MD, MSCE
David Suskind, MD
Betty Zheng, MD
Ghassan Wahbeh, MD
This study also lists 1 location outside the United States. It is not shown here.
Central study contacts
Registry dates
- First posted
- Jan 22, 2024
- Primary completion
- Apr 1, 2027
- Overall completion
- Jan 10, 2030
Trial information comes from ClinicalTrials.gov and may change. Confirm current status, eligibility, and site details with the study team. Aidy does not provide medical advice or determine eligibility.