Crohn DiseasemRE-EENNCT06216899
Reverse-Engineering of Exclusive Enteral Nutrition (RE-EEN) in Crohn's Disease: A Multi-Center Trial
A study testing Whole-food based smoothie and Formula in people with Crohn Disease, run by Seattle Children's Hospital at 3 sites in 2 countries.
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). Read more about this study
- Who is it for?
- Ages 8 to 21 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Whole-food based smoothie and Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 11 Mar 2024to 10 Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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)
Show all 13Show fewer
- 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.
Trial locations and contacts
3 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 2 countries
United States2 sites, 2 recruiting
- Not yet recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19146
Clarice Cook, 445-942-7445, cookc4@chop.edu
Lindsey Albenberg, DO
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Danny Gagucas, 206-987-1062, Danny.Gagucas@seattlechildrens.org
Dale Lee, MD, MSCE
Canada1 site, 1 recruiting
- Not yet recruiting
Izaak Walton Killam Health Centre
Halifax, Nova Scotia, B3J 0C3
Bradley MacIntyre MacIntyre, 902-470-7009, Brad.MacIntyre@iwk.nshealth.ca
Anthony Otley, MD, MSc
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.
- Conditions
- Crohn Disease
- Being tested
- Whole-food based smoothie, Formula
- Keywords
- Crohn's, Inflammatory Bowel Disease, CD
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole-food based smoothieOther
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.
FormulaOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Smoothie | Experimental | In the smoothie arm, you will be provided instructions, a blender, and food components to prepare the smoothie at home. Receives: Other: Whole-food based smoothie |
| Formula | Active comparator | In the formula arm, you will be given conventional formula as per the direction of the gastroenterology team along with our dieticians. Receives: Other: Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 and 8 weeks
Secondary outcomes (2)
Fecal Calprotectin reduction from baseline
Fecal calprotectin (FCP) level <250 μg/gram
Measured: 4 and 8 weeks
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)
Measured: 4 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start11 Mar 2024
- Primary completion1 Apr 2027 (estimated)
- Study completion10 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, Dalhousie University
- Responsible party
- Principal investigator, Dale Lee, Seattle Children's Hospital
- Investigators
- Dale Lee, MD, MSCE, Principal investigator, Seattle Children's Hospital, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216899
- Sponsor's protocol ID
- STUDY00004459
- Acronym
- mRE-EEN
- Status last verified
- Jun 2025
- First submitted
- 4 Jan 2024
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reverse-Engineering of Exclusive Enteral Nutrition (RE-EEN) in Crohn's Disease: A Multi-Center Trial
- ClinicalTrials.gov ID
- NCT06216899
- Acronym / sponsor ID
- mRE-EEN / STUDY00004459
- Conditions
- Crohn Disease
- Keywords
- Crohn's, Inflammatory Bowel Disease, CD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- Children's Hospital of Philadelphia, Dalhousie University
- Study start
- 11 Mar 2024 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 10 Jan 2030 (estimated)
- First posted
- 22 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smoothie | Experimental | Other: Whole-food based smoothieIn the smoothie arm, you will be provided instructions, a blender, and food components to prepare the smoothie at home. |
| Formula | Active comparator | Other: FormulaIn the formula arm, you will be given conventional formula as per the direction of the gastroenterology team along with our dieticians. |
Who may qualify
- Ages
- 8 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole-food based smoothieThe 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 | Smoothie |
| FormulaConventional 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. | Other | Formula |
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.
2 secondary outcomes
Fecal Calprotectin reduction from baseline
Time frame: 4 and 8 weeks
Pediatric Crohn's Disease Activity Index (PCDAI) reduction from baseline
Time frame: 4 and 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dale Lee, MD, MSCE principal investigator
Seattle Children's Hospital, University of Washington
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole-food based smoothie and Formula in people with Crohn Disease, run by Seattle Children's Hospital at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mason E Nuding (206-987-0055, mason.nuding@seattlechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerance- Ability to remain on prescribed nutritional therapy (time frame: 4 and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.